Active infection including hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg]) result or, hepatitis C; patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA); negative serologies documented over the past year are sufficient evidence of this
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease.\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment
Current treatment with anti-viral therapy for hepatitis B virus (HBV)
Participants who have hepatitis C (both reactive anti-hepatitis C virus [HCV] antibody and detectable HCV RNA) and hepatitis B (hepatitis B surface antigen [HBsAg] positive and anti-hepatitis B core [HBc]-total positive), may be enrolled, provided total bilirubin is =< 1.5 x institutional ULN, and AST (SGOT) and ALT (SGPT) must be =< 3 X institutional upper limit of normal, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 100 IU/mL (if hepatitis B positive) within 2 weeks prior to enrollment
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible)
Negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy; all participants will be required to be screened for hepatitis B; per Infectious Disease Society of America (IDSA) and Assistance for AIDS Specific Drugs (AASD) guidelines, those participants that show no immunity, defined by the lack of hepatitis B surface antigen antibody, and show evidence of chronic infection (i.e. hepatitis B surface antigen [HBsAg]+, hepatitis B core [HBcore]+, hepatitis B surface antibody [HBsAB]-) will be required to be on anti-hepatitis B therapy during the study in order to be eligible; patients will be permitted to enroll in the study provided normal liver function tests and no evidence of cirrhosis; the exact hepatitis B therapy will be at the discretion of the infection disease specialist or investigator; however all patients who present with acute hepatitis B or show normal transaminases and are hepatitis B virus HBsAg surface protein antigen (HBsAg) positive (+) and immunoglobulin M (IgM)+ for hepatitis core antigen will not be eligible for trial enrollment
Patients diagnosed with hepatitis C who are hepatitis C antibody positive, whether hepatitis C RNA level is measurable or not, must have no evidence of cirrhosis and have liver function tests
Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.
Positive screen for hepatitis B or C
Patients with known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection are not eligible; NOTE: patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load; patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load
Patients must not have known human immunodeficiency virus (HIV), or a known positive test for hepatitis B virus surface antigen (HBV sAg), or hepatitis C virus ribonucleic acid (HCV antibody) indicating current acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed
Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load, or in the opinion of the treating investigator is well-controlled, are eligible
No history of the following:\r\n* Active known or suspected autoimmune disease\r\n* Patients with human immunodeficiency virus (HIV) are eligible if the lymphocytes > 350 cluster of differentiation (CD)4+ cells and no detectable viral load\r\n* Symptomatic, untreated, or uncontrolled brain metastases present\r\n* Active autoimmune colitis \r\n* Autoimmune panhypopituitarism \r\n* Autoimmune adrenal insufficiency \r\n* Known active hepatitis B or C\r\n** Hepatitis B can be defined as:\r\n*** Hepatitis B surface antigen (HBsAg) > 6 months\r\n*** Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B\r\n*** Persistent or intermittent elevation in alanine aminotransferase (ALT)/alanine aminotransferase (AST) levels\r\n*** Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation\r\n** Hepatitis C can be defined as:\r\n*** Hepatitis C antibody (Ab) positive\r\n*** Presence of hepatitis C virus (HCV) ribonucleic acid (RNA)\r\n* Known active pulmonary disease with hypoxia defined as:\r\n** Oxygen saturation < 85% on room air or\r\n** Oxygen saturation < 88% despite supplemental oxygen
Patients with evidence of active hepatitis B virus (HBV) or hepatitis C Virus (HCV) infection are not eligible; patients with cleared HBV and HCV infection will be allowed
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, patients are excluded
No known active hepatitis B or C\r\n* Active hepatitis B can be defined as: \r\n** Hepatitis B virus surface antigen (HBsAg) detectable for > 6 months;\r\n** Serum hepatitis B virus (HBV) DNA 20,000 IU/ml (105 copies/ml); lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B\r\n** Persistent or intermittent elevation in ALT/AST levels \r\n** Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation\r\n* Active hepatitis C can be defined as: \r\n** Hepatitis C antibody (AB) positive AND \r\n** Presence of hepatitis C virus (HCV) RNA
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Patients with hepatitis B virus (HBV) infection are eligible provided they meet the other eligibility criteria and:\r\n* There is no evidence of hepatic damage related to HBV infection\r\n* They have had consistently suppressed HBV viral load to undetectable levels by polymerase chain reaction (PCR) for a minimum of 12 months
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease; however, \r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
No known chronic active liver disease or evidence of acute or chronic hepatitis B virus (HBV) or hepatitis C (HCV)
Patients cannot have:\r\n* Active central nervous system or meningeal involvement by lymphoma; patients with a history of central nervous system (CNS) or meningeal involvement must be in a documented remission by cerebrospinal fluid (CSF) evaluation and contrast-enhanced magnetic resonance imaging (MRI) imaging for at least 91 days prior to registration\r\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\r\n* A known bleeding diathesis\r\n* Requirement for warfarin or similar vitamin K antagonists; these drugs are prohibited 28 days prior to the first treatment and throughout the trial\r\n* History of stroke or intracranial hemorrhage =< 6 months before treatment\r\n* Currently active, clinically significant hepatic impairment (Child-Pugh class B or C according to the Child Pugh classification\r\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib or other agents used in study\r\n* Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment; (PCR positive patients will be excluded)
Patients must not have active hepatitis B (chronic or acute) or active hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection as evidenced by testing performed within 28 days prior to registration; patients with past or resolved HBV infection are eligible; active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test; past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test; patient must not have active hepatitis C virus (HCV) infection as evidenced by testing performed within 28 days prior to registration; active HCV is defined as having a positive HCV antibody test followed by a positive HCV RNA test
Negative serology (antibody test) for the following infectious diseases:\r\n* Human immunodeficiency virus (HIV) type 1 and 2\r\n* Human T-cell leukemia virus (HTLV) type 1 and 2 (mandatory in United States [US] but optional in Canada and Europe)\r\n* Hepatitis B surface antigen\r\n* Hepatitis C antibody
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA
Patient has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, human immunodeficiency virus HIV-1 or HIV-2 antibody, or has a history of a positive result for hepatitis C virus (HCV) or HIV
Positive hepatitis B or C serology.
Active infection with hepatitis B virus (HBV) (positive hepatitis B surface antigen); HCV is allowed only in HCC participants. HCC participants at risk for HBV reactivation (as defined by anti-hepatitis B core antibody positive) are only eligible in the HCC cohort.
Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (subjects with laboratory evidence of cleared HBV and/or HCV will be permitted)
Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection.
Negative for active HBV and HCV at screening
Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
Positive for hepatitis C virus (HCV) antibody at screening
Participants known to be human immunodeficiency virus (HIV)-positive or known to have active hepatitis B or C; Note: Participants in whom hepatitis C virus (HCV) infection resolved spontaneously (positive HCV antibodies without detectable HCV-ribonucleic acid [RNA]) or those that achieved a sustained virological response after antiviral treatment and show absence of detectable HCV RNA >= 6 months (with the use of IFN-based regimens) after cessation of antiviral treatment are eligible
Active hepatitis B virus (HBV) or hepatitis C (HCV) infection;
Positive serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection
Significant acute or chronic infection including, among others: Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as, HBV surface antigen positive and HBV core antibody positive with reflex to positive HBV DNA or HBV core antibody positive alone with reflex to positive HBV DNA or positive HCV antibody with reflex to positive HCV RNA).
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Known hepatitis B surface antigen seropositivity or known or suspected active hepatitis C infection; Note: Patients who have isolated positive hepatitis B core antibody (i.e. in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load
Positive for Hepatitis B surface antigen.
Any positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAG) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection
Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Subjects who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation. Prophylaxis should be initiated prior to lymphodepleting therapy and continued for 6 months.
Active hepatitis C subjects as demonstrated by test for hepatitis C ribonucleic acid (RNA). Subjects who are HCV antibody positive will be screened for HCV RNA by any RT-PCR or by DNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.
No known positivity of hepatitis B surface antigen (HBsAg), or of positive hepatitis C antibody
Current or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or HCV antibody at screening
Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Negative hepatitis B surface antigen (HBsAg) test at screening
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test.
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
Active hepatitis C (defined as a positive HCV viral load)
Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
Patients should be excluded if they are positive test for hepatitis B virus surface antigen (hepatitis B virus [HBV] surface antigen [sAg]) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection
Escalation part: Active Hepatitis B (HBV) or Hepatitis C (HCV) virus infection at screening. Expansion part: Patients with active HBV or HCV are excluded, excepting those patients undergoing treatment for HBV or HCV.
Subject who tests positive for hepatitis B surface antigen (HBVsAg) or hepatitis C ribonucleic acid (RNA) indicating acute or chronic infection;
Subject has known positivity for Hepatitis B surface antigen or Hepatitis C antibody
Patients with known clinically significant liver disease (have previously tested positive), including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Known chronic hepatitis B or C virus (HBV/HCV) infection
Participants who are hepatitis C virus antibody positive, or hepatitis B virus surface antigen positive must be free of clinical evidence of cirrhosis as determined by the principal investigator in consultation with the gastroenterology service; timeline: within 3 weeks prior to enrollment
Active infection requiring therapy, positive tests for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive at screening must not be enrolled until further definite testing with Hepatitis B virus (HBV) DNA titers and HCV RNA tests can conclusively rule out presence of active infection.
Active viral disease or positive test for hepatitis B virus using hepatitis B surface antigen test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid or HCV antibody test indicating acute or chronic infection. Positive test for HIV or AIDS; testing is not required in the absence of history
Hepatitis B surface antigen (HBsAg) positivity without active treatment; a subject found to be HBsAg positive should be on antiviral therapy for at least two weeks prior to study registration
Active infection requiring therapy, including known positive tests for Hepatitis B surface antigen and hepatitis C virus (HCV) RNA
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Symptomatic congestive heart failure of New York heart Association class III or IV\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function as defined as spirometry and carbon monoxide diffusing capability test (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 89% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Patients who have a clinically active hepatitis B or C virus infection are not eligible; NOTE: those with documented evidence of past exposure to hepatitis B virus (HBV) or hepatitis C virus (HCV) may enroll so long as the respective viral load is negative AND subject is willing/able to take appropriate antiviral prophylaxis to prevent reactivation
Child-Pugh B or C hepatic impairment; patients with a history of hepatitis or significant exposure risk should be tested for hepatitis B and C with serologic markers: hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBs Ab), hepatitis B core immunoglobulin G antibody (HBcoreIgG Ab), hepatitis C virus antibody (HCV Ab); patients with active hepatitis B or C are excluded
Active hepatitis C infection, defined as presence of hepatitis C virus (HCV) antibody; active hepatitis B infection is allowed, defined as presence of hepatitis B virus (HBV) surface antigen by polymerase chain reaction (PCR) if subject is agreeable to antiviral therapy with entecavir or lamivudine (must have virologic control of hepatitis B); subjects will require HBV PCR monitoring per institutional standard
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen or hepatitis B core antibody
Known history of hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible); it is not necessary to conduct HBV and HCV testing at screening
Patients should be excluded if they are known to be positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection
Patients are not eligible who have clinically active hepatitis B (tested at screening) or known hepatitis A or C infections;\r\n* NOTE: Patients with chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection may enroll if other laboratory criteria are met; those with HBV surface antigen positivity may enroll only if maintained on appropriate suppressive antiviral therapy, per treating investigator’s discretion, for the duration of enrollment in the trial
Known hepatitis B surface antigen (HBsAg) positive.
Known hepatitis C virus (HCV) antibody positive.
Negative hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) DNA
Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA)
Known to be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels . Those who are polymerase chain reaction (PCR) positive will be excluded
Known to be seropositive for hepatitis C (anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy
Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb), unless hepatitis C virus ribonucleic acid (HCV RNA) undetected/negative.
Known human immunodeficiency virus carrier or a diagnosis of immunodeficiency; any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, eg, hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-hepatitis C virus [HCV]) positive (except if HCV-ribonucleic acid [RNA] negative)
Active infection including hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Subjects with known active hepatitis B (HBV) or hepatitis C (HCV) infection as defined by the following (hepatitis screening studies are required):\r\n* Positive test for hepatitis B surface antigen\r\n* Positive test for hepatitis C antibody and/ or hepatitis C quantitative viral load (Note: subjects with a positive hepatitis C antibody and negative quantitative hepatitis C polymerase chain reaction [PCR] viral load are eligible)
HBV surface antigen (HBsAg) positive
HBV surface antigen (HBsAg) negative, HBV surface ant ibody (ant i-HBs) posit ive and/or HBV core antibody (ant i-HBc) positive, and detectable viral DNA Subjects who are seropositive because of prior HBV vaccination are eligible (anti- HBs positive, anti-HBc negative, and HBsAg negative).
Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines.
Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA.
Obtained within 14 days prior to C1D1: Hepatitis B virus (HBV) surface antigen negative
Obtained within 14 days prior to C1D1: HBV surface antibody positive or negative
Obtained within 14 days prior to C1D1: HBV core antibody negative\r\n* Subjects whose HBV core antibody is positive must have a negative HBV viral load measurement
Obtained within 14 days prior to C1D1: Anti-hepatitis C virus (HCV) total antibody negative
Patients with a positive hepatitis B core antibody (HBVcAb) must have negative viral load measurement
Active hepatitis B or hepatitis C (defined as positive-HBV surface antigen or detectable HCV-antibody); patients with a positive Hepatitis B core antibody (HBVcAb) must have negative viral load measurement
Presence of positive test results for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HcAb) (for participants receiving regimen including rituximab)
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment; ongoing infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen [HBsAg] positive) or hepatitis C virus (anti hepatitis C virus [HCV] positive); a history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing
Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive because of hepatitis B virus vaccine are eligible; patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Suppression of hepatitis B (HBV) (=< 100 IU/mL by HBV polymerase chain reaction [PCR]) with antivirals per the local standard of care if prior or current HBV exposure or infection
Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus
Subjects with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) (cannot have an elevated viral load of HBV or HCV if known history) are ineligible
If active hepatitis B virus (HBV), viral load must be < 100 IU/mL; if active HBV, subjects must be on anti-viral medication for >= 3 months prior to study registration and remain on the same anti-viral regimen throughout study treatment; NOTE: those subjects who are positive for hepatitis B core antibody (anti-HBc), negative for hepatitis B surface antigen (HBsAg) and negative for hepatitis B surface antibody (anti-HBs), and have an HBV viral load < 100 IU/mL do not require HBV anti-viral prophylaxis
Dual infection with HBV/HCV or other hepatitis combinations at study entry
Acute or active hepatitis B or hepatitis C infection. Patients with anti-hepatitis B core antigen (HBc) positive, or hepatitis B surface antigen (HBsAg) but viral deoxyribonucleic acid (DNA) negative are exception(s).
The subject is known to be positive for hepatitis B surface antigen (HepBsAg), or hepatitis C virus (HCV) ribonucleic acid (RNA)
Active systemic infection requiring therapy, positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
Hepatitis B - antigen positive
Hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb) blood test must be done at screening for all patients; patients who test positive for hepatitis C antibodies or the hepatitis B antigen are ineligible
No history of the following:\r\n* Child Pugh class B or C liver disease\r\n* “Chronic active” hepatitis defined as: \r\n** Hepatitis B surface antigen (HBsAg) > 6 months\r\n** Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B\r\n** Persistent or intermittent elevation in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels\r\n** Liver biopsy showing chronic hepatitis with moderate or severe necroin?ammation
Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Participant has active hepatitis B infection as determined by NAAT or surface antigen assay. Participants who have acquired immunity from past exposure (HBcAb positive / HBsAb positive / HBsAg negative) are eligible.
Active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)\r\n* Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, hepatitis C antibody, must have a negative polymerase chain reaction (PCR) result for the respective disease before enrollment; those who are PCR positive will be excluded
Patients with a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with/without active treatment
The subject is known to be positive for the human immunodeficiency virus (HIV), hepatitis B surface antigen (HepBsAg), or hepatitis C virus (HCV) ribonucleic acid (RNA)
Active Hepatitis B or C determined by a detectable viral load of HBV or HCV.
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Seropositive for Human Immunodeficiency Virus (HIV) 1 or HIV 2, or positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody
Patients with known hepatitis B or C virus (hepatitis B virus [HBV] or hepatitis C virus [HCV]) infection are eligible provided liver function parameters meet laboratory eligibility criteria\r\n* Patients with active HBV infection must have monitoring of viral load and demonstrate adequate treatment with appropriate antiviral therapy according to institutional practice\r\n* Patients with active HCV infection must have monitoring of liver function tests and viral load if indicated according to institutional practice
Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
DONOR: HIV negative, hepatitis B virus surface antigen negative, and hepatitis C virus antibody negative
Active hepatitis B infection (defined as presence of hepatitis [hep] B surface antigen [sAg] and/ or hep B deoxyribonucleic acid [DNA]), active hepatitis C infection (defined as presence of hep C ribonucleic acid [RNA]) and/or known human immunodeficiency virus (HIV) carrier
Known active hepatitis B (hepatitis B virus [HBV]) or hepatitis C (hepatitis C virus [HCV]) infection; patients who are positive only for HBV surface antibody as a result of prior vaccination are eligible; patients with a positive HBV core antibody but undetectable HBV viral load are eligible
Positive for Hepatitis B
Hepatitis B surface antigen (HBsAG) positive or hepatitis B core antibody positive
Hepatitis C virus (HCV) antibody positive
Human immunodeficiency virus (HIV) or active hepatitis B virus (HBV? chronic or acute? defined as having a positive hepatitis B surface antigen [Bag] test at screening) or active hepatitis C\r\n* Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBc Ab] and absence of hepatitis B surface antigen [HBsAg]) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to cycle 1, day 1, but detection of HBV DNA in these patients will not exclude study participation\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Known chronic hepatitis B or C (HBV/HCV) infection.
Patients who have a known active hepatitis B or hepatitis C infection are ineligible; patient must have documented evidence of negative tests for the presence of hepatitis B surface antigen and hepatitis C (anti-hepatitis C virus [HCV] antibody OR hepatitis [Hep] C RNA-qualitative); human immunodeficiency virus (HIV)-positive patients are eligible if the following criteria are met:\r\n* Stable on their antiretroviral agents\r\n* Have CD4 counts above 400\r\n* Undetectable viral loads, and\r\n* No need for prophylactic medications for an opportunistic infections
EXCLUSION CRITERIA FOR STRATUM C: Patients who have a known active hepatitis B or hepatitis C infection are ineligible; patient must have documented evidence of negative tests for the presence of hepatitis B surface antigen and hepatitis C (anti-HCV antibody OR Hep C RNA-qualitative); HIV-positive patients are eligible if the following criteria are met:\r\n* Stable on their antiretroviral agents\r\n* Have CD4 counts above 400\r\n* Undetectable viral loads, and\r\n* No need for prophylactic medications for an opportunistic infections
Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected); NOTE: patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of hepatitis B deoxyribonucleic acid (DNA) are not eligible for this study; patients with a positive hepatitis B core antibody but with negative hepatitis B DNA may participate, but must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician\r\n* NOTE: intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] or positive hepatitis B virus [HBV] deoxyribonucleic acid [DNA] test at screening) or hepatitis C
Seropositive for or active viral infection with hepatitis B virus (HBV):\r\n* Hepatitis B surface antigen (HBsAg) positive\r\n* HBsAg negative, anti-hepatitis B surface antibody (HBs) positive and/or anti-hepatitis B core antibody (HBc) positive and detectable viral deoxyribonucleic acid (DNA)\r\nNotes:\r\n* Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, but viral DNA negative are eligible\r\n* Subjects who are seropositive because of HBV vaccination are eligible (HBV surface antibody positive, HBV core antibody negative, and HBV surface antigen negative)
True positive test results for hepatitis A (immunoglobulin [Ig]M positive); subjects with a history of hepatitis A with IgG blood test are not excluded; true positive test results hepatitis B, or C infection
Patients with a history of hepatitis B (surface antigen or core antibody positive and polymerase chain reaction [PCR] positive) must take lamivudine or equivalent drug during study therapy and for one year after completion of all therapy; patients on intravenous immunoglobulin (IVIG) who are core antibody positive but PCR negative are not mandated to take prophylaxis
Known positive for HIV, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
Seronegative for active hepatitis B, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase (RT)-polymerase chain reaction (PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Documented negative human immunodeficiency infection virus (HIV) antigen and antibody, hepatitis B surface antigen, and hepatitis C antibody within 3 months prior to enrollment; for patient with positive hepatitis C antibody (Ab), negative polymerase chain reaction (PCR) testing must be documented in order to be eligible
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase (RT)-polymerase chain reaction (PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Haematological malignancy associated with human immunodeficiency virus (HIV) infection or solid organ transplant or history of known Hepatitis B Antigen or positive Hepatitis C antibody (confirmed by Recombinant ImmunoBlot Assay [RIBA], if available or alternately confirmed by Hepatitis C Virus [HCV] Ribonucleic acid [RNA]).
Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, hepatitis C or HTLV-II infection\r\n* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion\r\n* A positive hepatitis C serology is an exclusion criterion
Hepatitis B surface antigen or hepatitis B core antibody positive
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Patients with evidence of chronic active Hepatitis B (positive for HbsAg) and Hepatitis C (positive for viral RNA).
Seronegative for active hepatitis B, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.\r\n* Hepatitis B and C testing required =< 28 days prior to initiating protocol-indicated treatment, including at least: hepatitis B surface antigen (HBV sAg); and hepatitis C virus antibody (HCV Ab) or hepatitis C virus ribonucleic acid (HCV RNA).
Patients with known active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Significant acute or chronic infections including, among others:\r\n* Known history of testing positive for human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS).\r\n* Active tuberculosis.\r\n* Positive test for hepatitis B virus (HBV) surface antigen (and/or core antibody) and/or confirmatory hepatitis C virus (HCV) RNA (if anti-HCV antibody tested positive).
Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Active human immunodeficiency virus (HIV) infection or infectious hepatitis, type B or C.\r\n* Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of hepatitis B surface antigen [HBsAg]) may be included if HBV deoxyribonucleic acid (DNA) is undetectable. If enrolled, patients must be willing to undergo monthly HBV DNA testing.\r\n* HIV positive patients may enroll if they meet all of the below criteria:\r\n** HIV is sensitive to antiretroviral therapy.\r\n** Must be willing to take effective antiretroviral therapy if indicated.\r\n** No history of CD4 prior to or at the time of lymphoma diagnosis < 300 cells/mm^3.\r\n** No history of acquired immunodeficiency syndrome (AIDS)-defining conditions.\r\n** If on antiretroviral therapy, must not be taking zidovudine or stavudine.\r\n** Must be willing to take prophylaxis for pneumocystis jiroveci pneumonia (PCP) during therapy and until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm^3, whichever occurs later.
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative.
Active infection requiring systemic therapy including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).\r\n* Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
Significant acute or chronic infections including, among others: a. Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. b. Active hepatitis B virus (HBV) (HBV surface antigen positive) or hepatitis C virus (HCV) (HCV RNA positive). c. Subjects with known active tuberculosis (history of exposure or history of positive tuberculosis test plus presence of clinical symptoms, physical or radiographic findings).
Subjects are eligible to enroll if they have non-viral-HCC, or if they have hepatitis B virus (HBV)HCC, or hepatitis C virus (HCV)-HCC defined as follows:\r\n* HBV-HCC: controlled (treated) hepatitis B subjects will be allowed if they meet the following criteria:\r\n** Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be less than 100 IU/mL prior to first dose of study drug. Subjects on active HBV therapy with viral loads under 100 IU/ml should stay on the same therapy throughout study treatment. Subjects who are hepatitis B virus core antibody (anti-HBc) (+), negative for hepatitis B surface antigen (HBsAg), negative for hepatitis B virus surface antibody (anti-HBs), and have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis\r\n*** HCV-HCC: active or resolved HCV infection as evidenced by detectable HCV ribonucleic acid (RNA) or antibody. Patients who have failed HCV therapy as evidenced by detectable HCV RNA will be eligible. Subjects with chronic infection by HCV who are treated (successfully or treatment failure) or untreated are allowed on study. In addition, subjects with successful HCV treatment are allowed as long as there are >= 4 weeks between completion of HCV therapy and start of study drug. Successful HCV treatment definition: SVR12
Has dual active HBV infection (HBsAg [+] and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV infection (anti-HCV Ab [+] and detectable HCV RNA) at study entry
Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Previous test results obtained as part of standard of care (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with previous positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment
Patients with successfully treated hepatitis C virus (HCV) are eligible if HCV viral load is undetectable
Patients with a history of hepatitis B virus (HBV) are excluded
Known active hepatitis B (defined as most recent serum polymerase chain reaction [PCR] or hepatitis B surface antigen positive) or active hepatitis C (note, hepatitis C in sustained virologic response defined as negative ribonucleic acid [RNA] PCR at least 12 weeks after any therapy is permitted)
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Viral status (hepatitis B and C) must be known. All hepatitis B virus (HBV)-positive patients must be on antiviral medication for viral suppression.\r\n* Patients with concomitant HBV infection must have a confirmed diagnosis of HBV characterized by the presence of hepatitis B core antibodies, and be sufficiently suppressed with active antiviral treatment (per local institutional practice) prior to enrollment to ensure adequate viral suppression (HBV deoxyribonucleic acid [DNA] < 2000 IU/mL).\r\n* Patients with concomitant hepatitis C virus (HCV) infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV ribonucleic acid (RNA or anti-HCV antibody upon enrollment.
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV, as determined by enzyme-linked immunosorbent assay [ELISA] and confirmed by western blot) and hepatitis B and hepatitis C virus (HBV/HCV, as determined by hepatitis B surface antigen [HBsAg] and hepatitis C serology)
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) RNA negative
Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody\r\n* Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\r\n* Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV deoxyribonucleic acid (DNA )is undetectable. These patients must be willing to undergo monthly DNA testing
Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load; hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to hepatitis B virus (HBV) (i.e., hepatitis B surface antigen [HBsAg], hepatitis B surface antibody positive (anti-HBs+) and antibody to hepatitis B core antigen [anti-HBc–]) may participate
History of human immunodeficiency virus (HIV) infection or active hepatitis B or C; intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B deoxyribonucleic acid [DNA]) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
Positive test for hepatitis B virus surface antigen (HBV sAg) or detectable hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection.
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or chronic infection
Human immunodeficiency virus (HIV)/hepatitis B virus (HBV)/hepatitis C positive (HCV) infection:\r\n* Seropositive for HIV antibody; (patients with HIV are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy in the future should study results indicate effectiveness) \r\n* Seropositive for hepatitis C or positive for hepatitis B surface antigen (HbsAG)
Positive for acute or chronic Hepatitis B virus (HBV) infection
Acute or chronic Hepatitis C virus (HCV) infection
Positive hepatitis serology:\r\n* Hepatitis B virus (HBV): Patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B virus core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n** Patients with positive hepatitis B surface antigen (HBSAg) consistent with prior vaccination to HBV (i.e., hepatitis B virus surface antibody [anti-HBs]+, anti-HBc-) may participate\r\n** Patients suspected to have false positive serologic studies because of IV immunoglobulin administration are potentially eligible after negative PCR studies for viral DNA/ribonucleic acid (RNA) and discussion with the principal investigator\r\n* Hepatitis C virus (HCV): Patients with positive hepatitis C serology unless HCV RNA is confirmed negative and may be considered for inclusion in the study on a case-by-case basis (e.g., patients with negative viral load after HCV-specific treatment)
Active human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who have an undetectable HIV viral load with CD4 >= 200 and are on highly active antiretroviral therapy (HAART) medication are allowed; subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded; patients who have had hepatitis C but have finished treatment and are PCR negative will be allowed; (testing to be done only in patients suspected of having infections or exposures)
If HBV surface antigen (sAg) and/or core antibody (Ab) positive, must be treated with appropriate antiviral therapy according to institutional practice with HBV deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) less than 500 IU/mL
Active coinfection with HBV plus hepatitis delta (D) virus (HDV) or HCV:\r\n* Both hepatitis B and C as evidenced by detectable HBV surface antigen or HBV DNA and detectable HCV ribonucleic acid (RNA)\r\n* Hepatitis D infection (HDV antibody positive) in subjects with detectable hepatitis B surface antigen or HBV DNA
Significant acute or chronic infections including, among others: a) Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome; b) Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV surface antigen positive and HBV core antibody positive with reflex to positive HBV DNA or HBV core antibody positive alone with reflex to positive HBV DNA or positive HCV antibody with reflex to positive HCV ribonucleic acid [RNA]); c) Subjects with active tuberculosis (history of exposure or history of positive tuberculosis test plus presence of clinical symptoms, physical or radiographic findings).
Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice for patients suspected of having active infection), hepatitis B (known positive hepatitis B virus [HBV] surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
Positive serology for hepatitis B defined by a positive test for HBsAg
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or undetectable hepatitis B (HBV) deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (PCR) testing.
Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA) by quantitative PCR.
Seronegative for active hepatitis B, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcription polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody\r\n* Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\r\n* Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV deoxyribonucleic acid (DNA) is undetectable; these patients must be willing to undergo monthly DNA testing
Evidence of active hepatitis B infection, based on positive surface antigen or hepatitis B deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), or active hepatitis C infection; patients who are hepatitis B core antibody positive must take prophylaxis with lamivudine or equivalent and be willing to undergo monthly hepatitis B DNA PCR testing
Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
GENERAL: History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B
Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
Patients should be excluded if they are known to be positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive.
Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.
Key Inclusion Criteria:\n\n        Up to 5 prior regimens for MCL. Prior therapy must have included:\n\n          -  Anthracycline or bendamustine-containing chemotherapy and\n\n          -  Anti-CD20 monoclonal antibody therapy and\n\n          -  Ibrutinib or acalabrutinib\n\n        At least 1 measurable lesion\n\n        Platelet count ? 75,000/uL\n\n        Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min\n\n        Cardiac ejection fraction ? 50%, no evidence of pericardial effusion as determined by an\n        ECHO, and no clinically significant ECG findings\n\n        Baseline oxygen saturation >92% on room air.\n\n        Key Exclusion Criteria:\n\n          -  Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C\n             virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the\n             viral load is undetectable per standard serological and genetic testing\n\n          -  History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,\n             cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or\n             any autoimmune disease with CNS involvement\n\n          -  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or\n             requiring IV antimicrobials for management.
Subjects with a positive Hepatitis B surface antigen and/or antihepatitis B core antibody. Subjects with a negative polymerase chain reaction (PCR) assay are permitted with appropriate antiviral prophylaxis.
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive).
Positive HBV or HCV test indicating acute or chronic infection
Participant is known to be positive for hepatitis B or C infection [HCV Ab indicative of a previous or current infection; and/or positive HBs Ag or detected sensitivity on HBV DNA PCR test for HBc Ab and/or HBs Ab positivity] with the exception of those with an undetectable viral load within 3 months screening. Hepatitis B or C testing is not required.
Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
Patients must have no evidence of significant hematologic, renal, or hepatic dysfunction; patients with underlying hepatocellular disease should be given careful risk/benefit consideration prior to enrollment; patients with a history of any chronic hepatitis as evidenced by the following are ineligible:\r\n* Positive test for hepatitis B surface antigen (HBsAg)\r\n* Positive test for qualitative hepatitis C viral load (by PCR) (Note: subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible; history of resolved hepatitis A virus infection is not an exclusion criterion)\r\n* History of alcoholic or non-alcoholic steatohepatitis (NASH), auto-immune hepatitis, or previous grade 3-4 drug-related hepatitis, or any form of chronic liver disease
Patients must be hepatitis C virus (HCV) negative (by quantitative PCR [qPCR]) and hepatitis B virus core antibody (HBcAb) negative (no prior hepatitis B infection)
Active replication of hepatitis B or active hepatitis C (hepatitis C virus [HCV] ribonucleic acid [RNA] positive); those with prior disease who are PCR negative at enrollment and meet liver function eligibility criterion are eligible
Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV antibody) indicating acute or chronic infection
Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening
Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening\r\n* Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody test at screening, are eligible for the study\r\n* Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening; the HCV RNA test will be performed only for patients who have a positive HCV antibody test
Has active hepatitis B or hepatitis C infection; patients with a history of hepatitis B/C infection who have received anti-viral therapy and are disease free (hepatitis [Hep] B - negative hepatitis B surface antigen [HBsAg] and HBV deoxyribonucleic acid [DNA]; Hep C – negative HCV ribonucleic acid [RNA]) may be considered for enrollment after discussion with principal investigator
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection.\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
Current treatment with anti-viral therapy for hepatitis B virus (HBV)
Serologic status reflecting active hepatitis B or C infection; patients who are hepatitis B core antibody positive and who are antigen negative, will need to have a negative polymerase chain reaction (PCR) result prior to enrollment; those who are hepatitis B antigen positive or PCR positive, will be excluded
Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\r\n* Note: patients who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load
Documented negative human immunodeficiency virus (HIV) antigen and antibody, hepatitis B surface antigen, and hepatitis C antibody within 3 months prior to enrollment; for patient with positive hepatitis C antibody (Ab), negative PCR testing must be documented in order to be eligible
Patients who test positive for HBV or HCV
Clinically significant infection, including known human immunodeficiency virus (HIV) or hepatitis C infection, or known hepatitis B (Hep B) surface antigen positivity; patients with Hep B core positivity can be enrolled if the Hep B polymerase chain reaction (PCR) is negative, and they are on antiviral suppression
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; patients with documented cure from HCV infection will be included
Any positive test result for hepatitis B or C virus indicating acute or chronic infection.
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Antiviral therapy per local standard of care with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 100 IU/ml if active hepatitis B (HBV) infection
Has active co-infection with both HBV and hepatitis C virus (HCV) (detectable HCV ribonucleic acid [RNA] plus positive HBV surface antigen or HBV DNA)
Active hepatitis B virus (HBV, chronic or acute, defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C antibody; patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to cycle 1, day 1 and confirmed to be negative; patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Patients must be screened for hepatitis B virus (HBV); patients who are either hepatitis B surface antigen (HBsAg) positive or HBV-DNA positive must be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of study treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816; additional management of the patients would be provided by a physician with expertise in management of HBV, if needed; patients must have negative hepatitis C antibody (HCV-Ab) or positive HCV-Ab but undetectable level of HCV-ribonucleic acid (RNA); Note: patients with detectable HCV-RNA are not eligible for the study
hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
Active infection, including tuberculosis (clinical evaluation), hepatitis B, hepatitis C, or human immunodeficiency virus (HIV, positive HIV 1 or 2 antibodies); active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result; patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible; patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. If hepatitis C antibody test is positive then active infection has to be confirmed by hepatitis C RNA testing for the patient to be excluded.
No known active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with chronic or cleared HBV infection and HCV infection are eligible.
Known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B positivity (subjects with hepatitis B surface antigen [SAg] or core antibody positivity, who are receiving and responding to antiviral therapy directed at hepatitis B or are negative for hepatitis B virus [HBV] deoxyribonucleic acid [DNA], are allowed)
Has known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load.
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
Known active hepatitis B or hepatitis C virus (HBV or HCV):\r\n* Patients with past or resolved HBV infection (defined by a negative hepatitis B surface antigen [HBsAg] test and a positive anti-hepatitis B core antigen [anti-HBc] antibody test) are eligible; HBV DNA must be obtained in these patients prior to first day of study treatment\r\n*Patients who have been recently discovered to have HBV with positive HBsAg test and positive anti-HBc antibody test but who have been started on antiretroviral treatment with non-detectable HBV DNA are eligible; HBV DNA must be obtained in these patients prior to first day of study treatment
Patients with known active hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection:\r\n* Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Has known chronic or acute hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C infection (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\r\n* Note: To qualify for enrollment, antiviral therapy for hepatitis B virus (HBV) must be given for at least 3 months, and HBV viral load must be less than 100 IU/mL prior to first dose of stud drug; those on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout trial treatment; those subjects who are hepatitis B virus core antibody (anti-HBc) (+), and negative for HBsAg, and negative for hepatitis B virus surface antibody (anti-HBs), and have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis, but need close monitoring
Has dual infection with HBV/HCV or other hepatitis combinations at study entry
If positive for hepatitis B virus (HBV) exposure or prior infection, can continue to participate in trial with prophylactic entecavir (for HBV); if positive for hepatitis C virus (HCV) exposure or active infection, can participate in trial with monitoring for liver function abnormalities
Known hepatitis B virus (HBV) surface antigen seropositive or detectable hepatitis C virus (HCV) infection viral load. Note: Participants who have positive HBV core antibody or HBV surface antigen antibody can be enrolled but must have an undetectable HBV viral load.
Active infection with tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and purified protein derivative [PPD] testing if indicated), hepatitis B (known positive hepatitis B virus [HBV] surface antigen (HBsAg) result, hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies); subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; subjects positive for hepatitis C (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Hepatitis B virus surface antigen positive
Active hepatitis C infection with a positive PCR; subjects who are hepatitis C antibody positive and PCR negative may be eligible; in these cases the subjects will be monitored via hepatitis C virus (HCV) PCR throughout the study
Seronegative test for HIV-1/2 and hepatitis C antibodies (HCV), and a negative test for Hepatitis B antigen (HBsAg). If hepatitis C antibody test is positive, then the subject must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection.
Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\r\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\r\n* History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis\r\n* Hepatitis B virus surface antigen or hepatitis B core antibody positive\r\n* Active hepatitis C infection; NOTE: Subjects who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before enrollment; those with a positive PCR for hepatitis C are excluded\r\n* Uncontrolled and/or symptomatic thyroid disease\r\n* Active graft-versus (vs)-host disease (GVHD) requiring treatment or any history of >= grade II acute GVHD\r\n* Seizure activity within the past 4 weeks\r\n* Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study
Antiviral therapy for hepatitis C virus (HCV) and hepatitis B virus (HBV) is allowed, but patient should not be on interferon.
Subject with known history of human immunodeficiency virus (HIV) or if known seropositive for hepatitis C virus (HCV) or hepatitis B virus (HBV); HIV-positive patients on combination antiretroviral therapy are ineligible\r\n* NOTE: Patients seropositive for hepatitis B or C may be included if confirmed hepatitis C recombinant immunoblot assay (RIBA) negative or HCV ribonucleic acid (RNA) negative (qualitative)
Patients with treated hepatitis virus infections (hepatitis B or hepatitis C) are eligible if they have been definitively treated for 6 months, have no detectable viral load on quantitative PCR, and liver function tests (LFTs) meet eligibility requirements
Documented negative human immunodeficiency virus (HIV) antigen and antibody, hepatitis B surface antigen, and hepatitis C antibody within 3 months prior to enrollment; for patient with positive hepatitis C antibody (Ab), negative PCR testing must be documented in order to be eligible
Liver disease: Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Subjects cannot be positive for hepatitis B surface antigen or anti-hepatitis B core antibody.
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment; known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen [HBsAg] positive) or hepatitis C virus (anti hepatitis C virus [HCV] positive); a history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing
Active hepatitis B (hepatitis [Hep] B core antibody positive and subsequent Hep B surface antigen positive or Hep B deoxyribonucleic acid [DNA] positive) or hepatitis C infection (Hep C antibody positive and subsequent detectable viral load)
Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\r\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\r\n* Uncontrolled and/or symptomatic thyroid disease\r\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to cycle 1, day 1;\r\n* Known infection with human T-cell leukemia virus 1 (HTLV-1)\r\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV):\r\n** Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\r\n** Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative hepatitis B surface antigen [HBsAg]) may be included if HBV DNA is undetectable; these patients must be willing to undergo monthly DNA testing during treatment and for at least 12 months after completion of study therapy\r\n* Malabsorption syndrome or other condition that precludes enteral route of administration\r\n* Psychiatric illness/social situations that would limit compliance with study requirements
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid (RNA) if anti-HCV antibody screening test positive).
Patients known to be human immunodeficiency virus (HIV) positive, hepatitis B or C positive, or both rapid plasma reagin (RPR) and fluorescent treponemal antibody (FTA) positive; (hepatitis B surface or core antibody alone is not indicative of hepatitis B virus [HBV] infection)
Patients who are human immunodeficiency virus (HIV) positive but who have no prior acquired immunodeficiency syndrome (AIDS)-defining illness and have CD4 cells of at least 350/mm^3 are eligible; HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions; patients must not be sero-positive for hepatitis B (hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or seropositive for hepatitis C (anti-hepatitis C antibody positive); however, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
Participants with dual active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive [+] and /or detectable HBV deoxyribonucleic acid [DNA]) and, hepatitis C virus (HCV) infection (anti-HCV antibody [Ab] [+] and detectable HCV ribonucleic acid [RNA]) at study entry\r\n* Subjects with chronic infection by HCV who are treated with anti-hepatitis B therapy (successfully or treatment failure) or untreated are allowed on study; controlled (treated) hepatitis B subjects will be allowed if they meet the following criteria:\r\n** Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be less than 100 IU/mL prior to first dose of study drug; subjects on active HBV therapy with viral loads under 100 IU/ml should stay on the same therapy throughout study\r\ntreatment\r\n** Subjects who are anti-HBc (+), negative for HBsAg, negative for anti-HBs, and have a HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis\r\n* In addition, subjects with successful HCV treatment are allowed as long as there are >= 4 weeks between achieving sustained viral response (SVR) and start of study drug
Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C; patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible; patients positive for hepatitis c virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
Serologic evidence of current or past hepatitis B infection based on the results of testing for hepatitis B virus surface antigen (HBsAg) and anti-hepatitis B virus core (HBc) – patients positive for HBsAg or hepatitis B virus core antibody (HBcAb) are excluded
Positive test for hepatitis C antibody (patients with documented clearance of hepatitis C by polymerase chain reaction [PCR] following treatment will be permitted)
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing (if clinically indicated), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C; patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Known history of positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection.
Patients with hepatitis B virus (HBV) viral load > 100 IU/mL (antiviral therapy per local practice is required)
Known history of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection; but: a. patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for hepatitis C virus (HCV) RNA; b. patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible, but should sample for hepatitis B virus (HBV) DNA and referral to virologist to monitor for HBV reactivation
Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV RNA if anti-HCV antibody screening test positive)
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies); subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg) are eligible; subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Viral hepatitis:\r\n* Patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of detectable serum hepatitis B deoxyribonucleic acid (DNA) viremia are not eligible for this study\r\n* Patients with a positive hepatitis B core antibody but with negative hepatitis B DNA maybe considered for participation, but must agree to receive appropriate anti-hepatitis B viral therapy suppression therapy while on obinutuzumab and have hepatitis B DNA monitored every 4 weeks with real-time polymerase chain reaction (PCR) by the treating physician; these patients should be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n* Hepatitis C: patients with positive hepatitis C serology unless hepatitis C virus (HCV) ribonucleic acid (RNA) is confirmed negative by PCR
Seronegative for hepatitis B antigen and hepatitis C antibody; if hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcriptase polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative
No significant medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy, including\r\n* Unstable cardiovascular function\r\n* Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or hepatitis B surface antigen (HBsAg) (hepatitis B virus [HBV] surface antigen)\r\n* Markedly decreased visual acuity\r\n* Active infection requiring intravenous antibiotics
Hepatitis B virus (HBV) (hepatitis B surface antigen [HBs Ag] positive) or hepatitis C virus (HCV) (anti-HCV positive) patients are ineligible because of potential reactivation of hepatitis virus with temozolomide use
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection; a) Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible; b)\r\nPatients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR)\r\nis negative for HCV ribonucleic acid (RNA)
No active or chronic hepatitis infection; hepatitis C virus (HCV) antibody (for hepatitis C) and hepatitis B Surface antigen must be negative within 14 days prior to Step 2 registration
Ongoing or active systemic infection, known human immunodeficiency virus-ribonucleic acid (RNA) positive, known hepatitis B surface antigen seropositive, or known hepatitis C virus-RNA positive.
Significant acute or chronic infections including, among others:\r\n* Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Positive test for hepatitis B virus (HBV) surface antigen and / or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid indicating acute or chronic infection
Human immunodeficiency virus (HIV)-positive patients regardless of treatment are excluded; patients with evidence of active hepatitis B and hepatitis C infection with positive real time polymerase chain reaction (qPCR) are also excluded but patients with prior exposure to hepatitis B or C with negative qPCR are allowed
Hepatitis B virus (HBV) positive participants will be excluded
Subjects with active hepatitis B virus (HBV) (chronic or acute, defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C virus (HCV)\r\n* Subjects with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible\r\n* Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Active hepatitis B infection (defined as the presence of detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA] or hemoglobin E [HBe] antigen). Patients who are hepatitis B surface antigen (HBsAg) negative/hepatitis B surface antibody (HBsAb) positive but hepatitis B core antibody (HBcAb) positive are eligible, provided HBV DNA is negative. These patients must have monthly monitoring of HBV DNA for the duration of the study
Active hepatitis C, defined by the detection of hepatitis C ribonucleic acid (RNA) in plasma by polymerase chain reaction (PCR)
FOR ALL PHASES (Ib AND II): Hepatitis B (HBV) or hepatitis C (HCV); all patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel
Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
DONOR: Infectious disease screening performed within 30 days prior to stem cell mobilization per federal guidelines and is:\r\n* Seronegative for HIV 1+2 antibody (Ab) and/or HIV polymerase chain reaction (PCR), human T-cell leukemia virus (HTLV) I/II Ab, hepatitis B virus surface antigen (HBsAg), hepatitis B virus surface antibody (HBcAb), hepatitis C virus (HCV) Ab\r\n* Negative rapid plasma reagin (RPR) for syphilis
DONOR: Sero-positive for HIV-1 & 2 antibody, HTLV-I & II antibody, hepatitis B virus (HBV) and HCV
Positive hepatitis serology:\r\n* Hepatitis B virus (HBV): Patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B virus core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n* Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
Patients with a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection are not eligible
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection. a. Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. b. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Physical and laboratory test findings; a) positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or chronic infection; b) known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Known hepatitis B virus (HBV) or hepatitis B virus (HCV) (patients are excluded if they are positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection)
A history of hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (subjects with laboratory evidence of cleared HBV and/or HCV will be permitted
Active infection requiring systemic therapy or significant acute or chronic infections including, among others:\r\n* Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)\r\n* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
Immunocompromised patients, patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) and currently receiving antiretroviral therapy, active hepatitis B virus surface antigen (HBV sAg+), active hepatitis C (if antibody [Ab]+ then polymerase chain reaction [PCR]+) indicating acute or chronic infection
Significant acute or chronic infections including, among others:\r\n* Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Positive test for hepatitis B virus (HBV) surface antigen and/or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
Positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection
Participant is known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals (non-exclusionary medications) are not excluded.
Subject is known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc, respectively]) or hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-ribonucleic acid [RNA] quantitation positive)
Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Significant acute or chronic infections including, among others:\r\n* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Known history of testing positive for hepatitis B virus (HBV) surface antigen and/or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
Performance of a donor infectious disease screen panel including cytomegalovirus (CMV) antibody, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, HIV 1/2 antibody, HTLVA 1/2 antibody, rapid plasma reagin and Trypanosoma cruzi (T. cruzi) or per current standard institutional donor screen – must be negative for HIV and active hepatitis B
Negative for hepatitis B surface antigen; positive hepatitis B tests can be further evaluated by confirmatory tests; and if confirmatory tests are negative, the patient can be enrolled; patients with a known history of hepatitis B are not eligible
Seronegative for hepatitis C antibody unless antigen negative; if hepatitis C antibody test is positive, then patients must be tested for the presence of ribonucleic acid RNA by reverse transcription (RT)-polymerase chain reaction (PCR) and be hepatitis C virus (HCV) RNA negative; patients with a known history of hepatitis C are not eligible
Patients who have any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection are excluded
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Documented virology status of hepatitis, as confirmed by screening anti-hepatitis B surface antigen (HBsAg), anti-hepatitis B virus core antibody (HBc), and/or anti-hepatitis C virus (HCV)
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study including:\r\n* Symptomatic congestive heart failure of New York heart Association class III or IV\r\n* Unstable angina pectoris, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease\r\n* Severely impaired lung function with a previously documented spirometry and Carbon Monoxide Diffusing Capability Test (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air\r\n* Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* A known history of human immunodeficiency virus (HIV) seropositivity as reported by the patient\r\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of EVE (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)\r\n* Patients with an active, bleeding diathesis\r\n* Active or latent, untreated hepatitis B or C; a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) DNA and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
History of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies) or active hepatitis B (chronic or acute) or hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test must be performed in these patients prior to study treatment\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV) antibody indicating acute or chronic infection
DONOR: Performance of a donor infectious disease screen panel including cytomegalovirus (CMV) antibody, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus (HIV) polymerase chain reaction (PCR), HIV ½ antibody, human T-lymphotropic virus antibody (HTLVA) ½ antibody, rapid plasma reagin (RPR), treponema and trypanosoma Cruzi (T. Cruzi), plus nucleic acid testing (NAT) testing (hepatitis B virus [HBV], hepatitis C virus [HCV], West Nile virus [WNV], HIV by nucleic acid method); or per current panel – must be negative for HIV and active hepatitis B
Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
All participants will be required to be screened for hepatitis B; all participants who present with acute hepatitis B or show normal transaminases and are hepatitis B surface antigen (HBsAg) positive (+) and IgM+ for hepatitis core antigen will not be eligible for trial enrollment; per Infectious Diseases Society of America (IDSA) and Assistance for AIDS Specific Drugs (AASD) guidelines, those participants that show no immunity, defined by the lack of hepatitis B surface antibody, and show evidence of chronic infection (i.e. hepatitis B [HB]sAg+, HBcore+, hepatitis B surface antibody [HBsAB] negative [-]) will be required to be on anti-hepatitis B therapy, during the study, in order to be eligible; the exact hepatitis B therapy will be at the discretion of the infection disease specialist or investigator; if infected with hepatitis B, participants will be permitted to enroll in the study provided liver function tests meet criteria listed above, there is no evidence of cirrhosis AND participants will be required to be on anti-hepatitis B therapy
Known to be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (ie, participants who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
Positive study for Hepatitis B surface antigen or Hepatitis B or C confirmed by polymerase chain reaction (PCR)
Known active or chronic hepatitis B infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening); subject with past or resolved hepatitis B infection (defined as having a negative HBsAg test and positive antibody to hepatitis B core antigen test) are eligible; hepatitis B viral deoxyribonucleic acid (DNA) must be obtained in subjects with positive hepatitis B core antibody prior to first treatment start
Active hepatitis C infection; subjects positive hepatitis C antibody test are eligible if polymerase chain reaction (PCR) is negative for hepatitis C viral DNA
Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) as defined below\r\n* Positive serology for HIV\r\n* Active hepatitis B infection as determined by a positive test for hepatitis B surface antigen (Ag)\r\n* Active hepatitis C; patients will be screened for HCV antibody; if the HCV antibody is positive, a screening HCV ribonucleic acid (RNA) by any reverse transcriptase polymerase chain reaction (RT PCR) or branched deoxyribose nucleic acid (bDNA) assay must be performed at screening by a local laboratory with a Clinical Laboratory Improvement Act (CLIA) certification or its equivalent; eligibility will be determined based on a negative screening value; the test is not required if documentation of a negative result of a HCV RNA test performed within 60 days prior to screening is provided\r\n* Serology (CMV immunoglobulin G [IgG]) positive for active CMV
Active with hepatitis C virus (HCV) or hepatitis B virus (HBV), subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment, those who are PCR positive will be excluded; subjects who have an undetectable human immunodeficiency virus (HIV) viral load with CD4 >= 300 and are on highly active antiretroviral therapy (HAART) medication are allowed; previously treated hepatitis C patients are also allowed; as there is potential for hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with nivolumab-containing regimen
CELL PROCUREMENT: Patients with the following systemic viral infections will be excluded: active human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV) (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells); Note: to meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV1 and 2 antibody or polymerase chain reaction (PCR) negative for HTLV1 and 2, negative for hepatitis B surface antigen, or negative for HCV antibody or HCV viral load
LYMPHODEPLETION: Patients with the following systemic viral infections will be excluded: active HIV, HTLV, HBV, HCV; Note: To meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV1 and 2 antibody or PCR negative for HTLV1 and 2, negative for hepatitis B surface antigen, or negative for HCV antibody or HCV viral load
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: symptomatic congestive heart failure of New York Heart Association class III or IV; unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease; severely impaired lung function as defined as oxygen (O2) saturation that is 88% or less at rest on room air; uncontrolled diabetes as defined by blood glucose > 200 mg/dl (11.1 mmol/l); systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment; liver disease such as cirrhosis or chronic active hepatitis; positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Active human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who have an undetectable HIV viral load with CD4 >= 200 and are on highly active antiretroviral therapy (HAART) medication are allowed; subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded; patients who have had hepatitis C but have finished treatment and are PCR negative will be allowed; (testing to be done only in patients suspected of having infections or exposures)
Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection; Note: Patients who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load; patients who have positive hepatitic C antibody may be included if they have an undetectable hepatitis C viral load
Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Subjects who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA are anti-viral therapy may be enrolled.
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded; subjects with HIV must have a CD4 count at or above the institutional lower limit of normal and not taking prohibited CYP3A strong inhibitors
Evidence of active hepatitis B infection, based on positive surface antigen or hepatitis B deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), or active hepatitis C infection; patients who are hepatitis B core antibody positive must take prophylaxis with lamivudine or equivalent and be willing to undergo monthly hepatitis B DNA PCR testing
Active infection requiring therapy, including positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment
Has known active hepatitis B without hepatitis B virus (HBV) treatment (HBV infection with ongoing HBV treatment is allowed); has persistent chronic hepatitis C infection (successfully treated hepatitis C virus [HCV] infection is allowed)
Active hepatitis B infection (defined as presence of hepatitis B [Hep B] surface antigen [sAg] and/or Hep B deoxyribonucleic acid [DNA]), active hepatitis C infection (defined as presence of hepatitis C [Hep C] ribonucleic acid [RNA]) and/or known human immunodeficiency virus (HIV) carrier
Known history of hepatitis B virus (HBV) or hepatitis C (HCV) infection
Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) infection; subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Subjects with chronic infection by HCV who are treated or untreated are allowed on study; subjects with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV deoxyribonucleic acid (DNA) test at screening, are eligible for the study; in addition, subjects with successful treatment (defined as sustained virologic response [SVR12] or SVR24) are allowed as long as 4 weeks have passed between completion of HCV therapy and start of study drug
Has dual infection with HBV/HCV or other hepatitis combinations at study entry
Patients with history of hepatitis B or C infection are not permitted to enroll; to enroll patients must have no evidence of hepatitis B or C surface antigen (Ag) and negative hepatitis B core antibody (Ab); patients previously immunized for hepatitis B who are hepatitis B surface Ab positive, but surface Ag and core Ab negative are eligible
Active/chronic hepatitis B infection (based on positive surface antigen [HBsAg]), hepatitis C infection (based on positive antibody [HCV Ab]), or human immunodeficiency virus (HIV-1 or HIV-2, based on positive antibody)
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Has known active hepatitis B or C; active hepatitis B is defined as a known positive hepatitis B surface antigen (HBsAg) result; active hepatitis C is defined by a known positive hepatitis (Hep) C antibody (Ab) result and known quantitative hepatitis C virus (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay
Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating ongoing acute or chronic infection
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcriptase (RT)-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Patients with chronic hepatitis B are eligible as long as they have evidence of ongoing viral replication (detectable hepatitis B surface antigen [HBsAg], hepatitis B envelope antigen [HBeAg], or hepatitis B virus [HBV] deoxyribonucleic acid [DNA]); they must have HBV DNA viral load < 100 IU/mL at screening; in addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy; if not on antiviral therapy at screening, then the subject must initiate treatment per regional standard of care guidelines at the time of consent; both HBeAg positive and negative patients will be included
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by real time polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Active infection requiring therapy, positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
True positive test results for hepatitis A, B, or C during screening
Positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C serology.
Patients with known active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C are not eligible\r\n* NOTE: patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients 14 days prior to study registration\r\n* NOTE: patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Have active infection with human immunodeficiency virus (HIV) (negative HIV 1/2 antibody screen), hepatitis C (negative hepatitis C antibody screen), or hepatitis B (negative hepatitis B surface antigen); any positive serologies for HIV or viral hepatitis should be confirmed with appropriate confirmatory testing before concluding that an active infection is present; subjects with positive hepatitis core antibody are also excluded since the effect of long-term B cell depletion on the risk of hepatitis B reactivation is unknown
Patients who are hepatitis B or C positive
Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C RNA polymerase chain reaction (PCR) is obtained.
Active/chronic hepatitis B infection (based on positive surface antigen [HBsAg]), hepatitis C infection (based on positive antibody [HCV Ab]), or human immunodeficiency virus (HIV-1 or HIV-2, based on positive antibody)
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody; (the experimental treatment being evaluated in this protocol depends on an intact immune system; patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities)\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
mCRPC EXPANSION COHORT: Hepatitis B virus (HBV) -or hepatitis C virus (HCV)-positive patients are ineligible
Active hepatitis B infection (defined as the presence of detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA], hepatitis B e [HBe] antigen or hepatitis B surface [HBs] antigen); subjects with serologic evidence of prior vaccination (hepatitis B surface antigen [HBsAg] negative, anti-HBs antibody positive, anti-hepatitis B core [HBc] antibody negative) are eligible; patients who are HBsAg negative/hepatitis B surface antibody (HBsAb) positive but hepatitis B core antibody (HBcAb) positive are eligible, provided HBV DNA is negative
Active hepatitis C, defined by the detectable hepatitis C ribonucleic acid (RNA) in plasma by polymerase chain reaction (PCR)
Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies); patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded; subjects who have an undetectable human immunodeficiency virus (HIV) viral load with CD4 >= 200 and are on highly active antiretroviral therapy (HAART) medication are allowed
Virus or active hepatitis B virus infection; patients who are hepatitis B core antibody (Hep B cAb) positive may be eligible as long as there is no evidence of active infection with negative hepatitis B (Hep B) by polymerase chain reaction (PCR); in this case, Hep B PCR must be monitored monthly
Active infection requiring therapy, positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
Patients must have a negative test for HIV, Hepatitis A, B, and C.
Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection
PRIOR TO CELL PROCUREMENT: Patients who are positive for hepatitis B surface antigen are excluded; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive at baseline; subjects who are core antibody positive and viral load negative at baseline will be considered eligible
PRIOR TO LYMPHODEPLETION: Patients who are hepatitis B surface antigen positive are ineligible; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive; subjects who are core antibody positive and viral load negative will be considered eligible; subjects who are hepatitis B virus (HBV) core antibody positive and HBV viral load negative prior to lymphodepletion must have initiated anti-HBV prophylaxis prior to lymphodepletion
PRIOR TO LYMPHODEPLETION: Patients who are positive for hepatitis B surface antigen are excluded; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive at baseline; subjects who are core antibody positive and viral load negative at baseline will be considered eligible if the subject has initiated an anti-HBV prophylaxis regimen prior to lymphodepletion
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Patients who are positive for hepatitis B surface antigen are excluded; patients who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked; these subjects will be excluded if their viral load is positive at baseline; subjects who are core antibody positive and viral load negative at baseline will be considered eligible; these subjects must be receiving antiviral prophylaxis initiated prior to lymphodepletion
Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, hepatitis C\r\n* Positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antigen [HBsAb] positive and hepatitis B core antibody [HBcAb] negative) or a fully resolved acute hepatitis B infection is not an exclusion criterion\r\n* Positive hepatitis C serology is an exclusion criterion\r\nNOTE: HIV-positive patients are excluded from the study
Human immunodeficiency virus (HIV) negative and hepatitis B surface antigen (HBs-Ag) negative
Patient who has any severe and/or uncontrolled medical conditions such as: \r\n* Active or uncontrolled severe infection,\r\n* Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA]) and/or positive hepatitis B virus surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])\r\n* Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active bleeding diathesis\r\n* Uncontrolled arterial hypertension defined by blood pressure > 170/100 mm Hg at rest (average of 3 consecutive readings 5 min apart)\r\n* Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary
Has a known history of human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies); human T-cell lymphotropic virus (HTLV) 1 antibody (HTLV1) and/or HTLV2; active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected); patients with prior hepatitis B virus (HBV) vaccination (anti-HBs positive, HBsAg negative, anti-HBc negative) will NOT be excluded
Hepatitis B virus (HBV) surface-antigen positive unless receiving both tenofovir and lamivudine as part of antiretroviral therapy if HIV-infected
Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests, and if confirmatory tests are negative, the patient can be enrolled; patients with a known history of hepatitis B are not eligible
Seronegative for hepatitis C antibody unless antigen negative; if hepatitis C antibody test is positive, then patients must be tested for the presence of ribonucleic acid (RNA) by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) RNA negative; patients with a known history of hepatitis C are not eligible
Presence of human immunodeficiency virus (HIV) (antibody [Ab] positivity), or active hepatitis A, B or C infection (active infection will be defined as hepatitis A immunoglobulin M [IgM] Ab positivity, hepatitis B surface Ag positivity, or hepatitis C polymerase chain reaction [PCR] positivity, respectively)
Patients who test positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human T-lymphotropic virus (HTLV) I or II antibody, or are both rapid plasma reagin (RPR) and fluorescent treponemal antibody (FTA) positive are excluded
DONOR: Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors; tests include but are not limited to: hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody, hepatitis C antibody, Epstein-Barr virus antibody, human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV) I and II, varicella zoster (herpes zoster), herpes simplex antibody, cytomegalovirus antibodies, syphilis (rapid plasma reagin [RPR] profile) for adolescents and adults, measles for pediatric patients, West Nile virus, Chagas screen, and toxoplasma antibodies
Patients who test positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
Current or chronic hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV); subjects who are positive for hepatitis B or C core antibody or hepatitis B or C surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded; Note: Patients who are receiving intravenous immunoglobulins may become seropositive for hepatitis B antibodies; these patients are allowed on the study without additional testing
Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for Hepatitis B surface antigen (HBsAg or HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcription (RT)-polymerase chain reaction (PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (ribonucleic acid or hepatitis C virus [HCV] antibody) indicating acute or chronic infection
Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection
Active hepatitis B, either active carrier (hepatitis B surface antigen [HBsAg] +) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
Known human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation; HBV deoxyribonucleic acid (DNA) and testing for HCV ribonucleic acid (RNA) must be undetectable; at risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive
Participants who are Hepatitis B surface antigen positive (HBsAg+) (must be PCR negative) who are taking antivirals, are allowed to enroll.
Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and positive tuberculosis (TB) test (purified protein derivative [PPD], Quantiferon), hepatitis B (known positive hepatitis B virus [HBV] surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies)\r\n* Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible\r\n* Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Active Hepatitis A, B, or C infection or known to be positive for HCV RNA or HBV surface antigen. Patients who have been vaccinated against Hepatitis B and who are positive for ONLY the Hepatitis B surface antibody are permitted to participate in the study.
Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C; patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test) are eligible; patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months); patients with history of human immunodeficiency virus (HIV) disease are also excluded from the study
Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >=10,000 copies/mL, or >= 2,000 IU/mL)
Active hepatitis B as defined by seropositivity for hepatitis B surface antigen (HBsAg); subjects with positive hepatitis B core antibody titers and normal liver transaminases are allowed provided that antiviral prophylaxis is administered per institutional guidelines; NOTE: subjects with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis
Note - Subjects with a history of hepatitis B or C with normal ALT and undetectable HBV DNA or HCV RNA are eligible for this study
Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or HBsAg (hepatitis B virus [HBV] surface antigen); baseline testing for viral hepatitis is not required
Active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible)
Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
For non-HCC, there must not be acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
For HCC with prior hepatitis B and/or C infection, HBV and/or HCV viral load by real-time polymerase chain reaction (qPCR) must be undetectable, and they must not have had recent treatment within 12 weeks for HBV or HCV with certain antiviral medications.
DONOR: Negative testing for relevant communicable diseases\r\n* Testing for infectious disease includes:\r\n** Hepatitis B surface antigen (HBsAg)\r\n** Hepatitis B core antibody (Anti-HBc)\r\n** Hepatitis C antibody (Anti-HCV)\r\n** HIV 1 & 2 antibody (Anti-HIV-1, 2 plus O)\r\n** Human T-lymphotropic virus (HTLV) I/II antibody (Anti-HTLV I/II)\r\n** Rapid plasma reagin (RPR) (Syphilis Treponema pallidum [TP])\r\n** Cytomegalovirus (CMV) (Capture CMV)\r\n** Multiplex (MPX) for: HepB (HBV-PCR), HepC (HCV-PCR), HIV (HIV-PCR)\r\n** Nucleic acid testing (NAT) for West Nile Virus (WNV-PCR)\r\n** Trypanosoma cruzi (T. Cruzi) - enzyme immunoassay (EIA) (Chagas)\r\n* Laboratory testing for infectious disease will be performed at the time of initial donor assessment and must be performed within 30 days of the HSC collection; if multiple collections of HSC occur from the same donor, the infectious disease testing shall be performed within 30 days prior to each collection
Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
PHASE I STUDY ELIGIBILITY CRITERIA: \r\nHepatitis B virus (HBV)-or hepatitis C virus (HCV)-positive patients are ineligible
Concurrent uncontrolled illness not related to cancer, including but not limited to: • Ongoing or active infection, including human immunodeficiency virus (HIV), hepatitis B (HBV) (hepatitis B surface antigen [HBsAg] positive; subjects with documented laboratory evidence of HBV clearance may be enrolled) or hepatitis C (HCV) (positive HCV antibody), or bleeding
Patients should be excluded if they are known to be positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Seropositive for HIV antibodies (HIV1 and HIV2), Hepatitis C antibody (Hep C Ab) or a Hepatitis B carrier (positive for Hepatitis B surface antigen [HBsAg]).
Patients who have any severe and/or uncontrolled medical conditions such as: a. serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease b. active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive surface antigen of the hepatitis B virus [HBsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]), c. known severely impaired lung function (spirometry and Diffusing capacity of the lungs for carbon monoxide [DLCO] 50% or less of normal and oxygen (O2) saturation 88% or less at rest on room air), d. active, bleeding diathesis; e. Moderate or severe hepatic impairment (Child-Pugh B or C)
Acute or chronic hepatitis B or hepatitis C infection (requires negative test for clinically suspected hepatitis B or hepatitis C infection)\r\n* Evidence of hepatitis B -\r\n** Positive hepatitis B virus (HBV) surface antigen (indicative for chronic hepatitis B or recent acute hepatitis B)\r\n** Negative HBV surface antigen but positive HBV total core antibody (indicative for resolved hepatitis B infection or occult hepatitis B) and detectable copies of HBV deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) (detectable HBV DNA copies suggest occult hepatitis B)\r\n* Evidence of hepatitis C - \r\n** Positive hepatitis C virus (HCV) antibody and positive HCV ribonucleic acid (RNA) by PCR (undetectable RNA copies suggest past and resolved hepatitis C infection)
Have received a diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (patients who are hepatitis C antibody positive may be enrolled if they are confirmed with negative viral load at screening)
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Have received a diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (patients who are hepatitis C antibody positive may be enrolled if they are confirmed with negative viral load at screening)
DONOR: Seronegative for human immunodeficiency virus (HIV) antigen (Ag), HIV 1+2 antibody (Ab), human T-lymphotropic virus (HTLV) I/II Ab, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) (immunoglobulin [Ig]M and IgG), hepatitis C virus (HCV) Ab, rapid plasma reagin (RPR) for syphilis within 30 days of apheresis collection
History of acute/chronic hepatitis B or C and/or carriers of hepatitis B or C (positive for hepatitis B surface antigen or positive anti-hepatitis C antibody test) and evidence of current or active infection (e.g. HCV RNA test)
Patients with active hepatitis B (defined as a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C\r\n* Patients with past hepatitis B virus infection or resolved hepatitis B virus (HBV) infection (defined as a negative HBSAg test and a positive antibody to hepatitis B core antigen antibody test) are eligible\r\n* Patients with a hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Hepatitis B surface antigen (+) or hepatitis C positive in preceding six months
Active hepatitis B or hepatitis C (virus detectable by polymerase chain reaction [PCR])
A history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; subjects with laboratory evidence of cleared HBV and/or HCV will be allowed
Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they are negative for HCV-RNA
Patients who are hepatitis B core antibody positive and or have positive hepatitis B surface antigen will require hepatology consultation; the risk/benefit profile of transplant and hepatitis B will be discussed with the patient and eligibility determined by the PI or the LAI
Any positive test for hepatitis C virus (HCV) RNA or hepatitis B surface antigen (HBsAg)
Hepatitis B surface antigen positive
Hepatitis C virus (HCV) antibody positive and detectable HCV quantitative ribonucleic acid (RNA), with clinical evidence of cirrhosis as determined by the principal investigator
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Patients who have any severe and/or uncontrolled medical conditions such as: \r\n* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus test [hepatitis B virus (HBV)-deoxyribonucleic acid (DNA)] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus test [hepatitis C virus (HCV)-ribonucleic acid (RNA)])\r\n* Known severely impaired lung function (spirometry and carbon monoxide diffusing capacity [DLCO] 50% or less of normal and oxygen [O2] saturation 88% or less at rest on room air)\r\n* Active, bleeding diathesis
Evidence of active acute or chronic hepatitis B (HBV); subjects with acute or chronic active HBV will be defined based on Centers for Disease Control and Prevention (CDC) guidelines; this will include subjects with positive serology for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc) associated with HBV-deoxyribonucleic acid (DNA) positive test by real time quantitative polymerase chain reaction (qPCR) assessment; subjects, who are anti-HBc positive and HBsAg negative or HBV-DNA test negative, may be enrolled in the study and should undergo regular monitoring of HBV viral load using HBV-DNA qPCR; those subjects may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management including antiviral therapy
Evidence of active hepatitis C (HCV); subjects with positive hepatitis C serology and positive HCV ribonucleic acid (RNA) test
Documented negative human immunodeficiency virus (HIV) antigen and antibody, hepatitis B surface antigen and hepatitis C antibody within 3 months prior to enrollment; for patients with positive hepatitis C antibody (Ab), negative polymerase chain reaction (PCR) testing must be documented in order to be eligible
known active hepatitis B infection (positive HBV surface antigen (HBsAg)). Patients with a past or resolved hepatitis B infection (defined as presence of hepatitis B core antibody (anti-HBc) and absence of HBSAg) are eligible;
known active hepatitis C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RA;
Active systemic infection requiring therapy, positive tests for hepatitis B surface antigen or hepatitis C antibody
Active hepatitis B or C with uncontrolled disease\r\n* Note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus surface antigen (HBsAg) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior hepatitis B virus (HBV) infection
Serologic status reflecting active hepatitis B or C; patients with hepatitis B (HBV) antibody positive but who have positivity for hepatitis B surface antigen (HBsAg) or anti hepatitis B core antibody (anti-HBc) and patients who are positive for anti-hepatitis C (HCV) will need to have a negative polymerase chain reaction (PCR) (viral HBV deoxyribonucleic acid [DNA] or HCV ribonucleic acid [RNA]) result prior to enrollment; those who are HBsAg positive or HBV DNA positive and those who are positive for HCV (RNA) will be excluded
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by real time (RT)-polymerase chain reaction (PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
No known active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV); patients with chronic or cleared HBV infection and HCV infection are eligible
Positive serological test results for hepatitis B
Positive serological test result for hepatitis C
Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing); patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Patients who demonstrate the presence of antibodies to human immunodeficiency virus (HIV) or hepatitis C or presence of hepatitis B surface antigen or other active infectious process that could suppress the immune system and potentially interfere with the development of an immune response to the tumor antigen are NOT eligible for participation
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Specific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on hepatitis B serological testing as follows:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) negative, hepatitis B surface antibody (HBsAb) positive patients are eligible\r\n* Patients who test positive for HBsAg are ineligible (regardless of other hepatitis B serologies)\r\n* Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing done and protocol eligibility determined as follows:\r\n** If HBV DNA is positive, the subject will be excluded from the study\r\n** If HBV DNA is negative, the subject may be included but must undergo at least every 2 months HBV DNA polymerase chain reaction (PCR) testing from the start of treatment throughout the duration the treatment course
Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [Sag] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
RECIPIENT: Chronic active hepatitis B; patient may be hepatitis B core antibody positive; for patients with a concomitant positive hepatitis B surface antigen, patients will require a hepatology consultation; the risk-benefit profile of transplant and hepatitis B will be discussed with the patient, and eligibility determined by the PI or lead associate investigator
MATCHED RELATED DONOR: Donors must be HIV negative, hepatitis B surface antigen negative, and hepatitis C antibody negative; this is to prevent the possible transmission of these infections to the recipient
HAPLOIDENTICAL RELATED DONOR: Donors must be HIV negative, hepatitis B surface antigen negative, and hepatitis C antibody negative; this is to prevent the possible transmission of these infections to the recipient
Hepatitis B surface antigen negative and hepatitis C antibody negative
DONOR: Must be human immunodeficiency virus (HIV)-1&2 antibody, HTLV-I&II antibody, hepatitis B virus (HBV) and hepatitis C virus (HCV) sero-negative, by Food and Drug Administration (FDA) licensed test
Active hepatitis B, either active carrier (hepatitis B virus surface antigen [HBsAg] +) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
DONOR: Evidence of active infection (including urinary tract infection, or upper respiratory tract infection), viral hepatitis exposure (on screening), unless only hepatitis B surface antibody (HBsAb)+ and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) negative, or serologic of exposure or infection with HIV-I/II or HTLV-I/II
No active hepatitis B or C (if hepatitis B surface antigen positive [HBsAg+] or hepatitis C virus antibody positive [HCV ab+], viral load must be undetectable), and if serologies are positive, MUST HAVE hepatology clearance for ASCT
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by reverse transcriptase (RT)-polymerase chain reaction (PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Negative serologies for hepatitis B (HB) defined as a negative test for HB surface antigen (sAg); in addition, if negative for HBsAg but HB core antibody (cAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if negative, patient may be included but must undergo hepatitis B virus (HBV) DNA polymerase chain reaction (PCR) testing at the beginning of treatment and throughout treatment duration, at least every 2 months; in addition patients will require treatment with Entecavir 0.5 mg orally (PO) a day (qday) per Memorial Sloan Kettering Cancer Center (MSKCC) institutional guidelines
Patients with known active hepatitis B virus (HBV) infection should be excluded; however, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related complications, and is on definitive HBV therapy, then he/she would be eligible for study
Patients with known active hepatitis C virus (HCV) infection; patients with a history of HCV infection who received definitive therapy and has an undetectable viral load by PCR would be eligible
Subjects with chronic hepatitis B or C as defined as test subjects with positive hepatitis (Hep) B serology:\r\n* Subjects with a negative hepatitis B virus surface antigen (HBsAg) and a positive hepatitis B core antibody (HBcAb) require an undetectable/negative hepatitis B deoxyribonucleic acid (DNA) (e.g., polymerase chain reaction [PCR] test) to be enrolled, and will require prophylactic antiviral treatment (e.g., F) initiated prior to the first dose of study drug, and continued until approximately 6 to 12 months after completion of study drug(s)
Patients with positive hepatitis C virus
Patients with brain metastases or presence of other intracranial lesions at risk for bleeding by history or baseline radiologic imaging. Active infection, including Hepatitis B and Hepatitis C infection. Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are exception(s).
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, currently requiring medical intervention, per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection requiring treatment with currently an unknown status. History of treated hepatitis is not exclusionary
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Chronic active hepatitis B; patient may be hepatitis B core antibody positive; for patients with a concomitant positive hepatitis B surface antigen, patients will require a hepatology consultation; the risk-benefit profile of transplant and hepatitis B will be discussed with the patient, and eligibility determined by the PI and the protocol chairperson
MATCHED RELATED DONOR: Donors must be human immunodeficiency virus (HIV) negative, hepatitis B surface antigen negative, and hepatitis C antibody negative
HAPLOIDENTICAL RELATED DONOR: Donors must be HIV negative, hepatitis B surface antigen negative, and hepatitis C antibody negative
DONOR: Donors must be human immunodeficiency virus (HIV) negative, hepatitis B surface antigen negative, and hepatitis C antibody negative
Patients with active hepatitis B, either active carrier (hepatitis B surface antigen [HBsAg] +) or viremic (hepatitis b virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or hepatitis C infection. For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded. Subjects with positive serology but negative hepatitis C virus (HCV) ribonucleic acid (RNA) test results are eligible.
Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study treatment.
Positive Hepatitis C test result at screening or within 3 months prior to first dose of study treatment.
With ongoing or active systemic infection requiring intravenous (IV) medical management, known human immunodeficiency virus (HIV-RNA) positive, known hepatitis B surface antigen seropositive, or known hepatitis C virus-RNA positive. Note: Participants who have positive hepatitis B core antibody can be enrolled but must have hepatitis B virus-DNA negative. Participants who have positive hepatitis C antibody can be enrolled but must have hepatitis C virus-RNA negative.
Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening
Participant must have the following indicator- of chronic hepatitis C virus infection prior to study enrollment: • Positive for HCV RNA at the time of screening
Positive test result for hepatitis B surface antigen (HBsAG), hepatitis B core antibody (HBcAb), or confirmed positive anti-HIV antibody test
Active infection including hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result) or hepatitis C; patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening
Known hepatitis B surface antigen seropositivity or known or suspected active hepatitis C infection\r\n* Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load; patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load
Patients with positive test for hepatitis C ribonucleic acid (HCV RNA)
Patients who are Hepatitis B or Hepatitis C antibody positive.
Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
Patients with positive serology for hepatitis B (HB), defined as a positive test for HB surface antigen (HBsAg), are NOT eligible; if negative for HBsAg but HB core antibody (HBcAb) positive a HB deoxyribonucleic acid (DNA) test will be performed; if HB DNA test is positive the patient is NOT eligible; NOTE: patients who are positive for HBcAb but negative for hepatitis B virus (HBV) antigenemia and viremia (HBsAg negative and HB DNA test negative) may be eligible for the study, but should be referred to hepatology for consultation and must be started on HBV suppression therapy with lamivudine or equivalent anti-HBV agents throughout the treatment and for a year after the completion of the treatments; these patients need to have liver function tests (LFTs) and HBV viral titer monitoring at least monthly during the treatment and for a year after treatment completion
Patients with positive serology for hepatitis C are NOT eligible
Known Hepatitis B surface antigen positive or hepatitis C positive
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at screening or within 3 months prior to first dose of study treatment.
Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
212 Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B). Negative HBsAg and positive for hepatitis B core antibody: Assay for hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B. Positive Hepatitis C virus antibody (HCVAb): Assay for hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
Positive HBV or HCV test indicating acute or chronic infection.
Subjects with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus RNA or hepatitis C antibody (HCV antibody) indicating acute or chronic infection.
Patients with known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver/nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH); and inherited liver disease\r\n** Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n** Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection (anti-HCV Ab(+) and detectable HCV RNA) at study entry.
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Untreated HIV or active hepatitis C detectable by polymerase chain reaction (PCR), or chronic hepatitis B (patients positive for hepatitis B core antibody who are receiving intravenous immunoglobulin (IVIG) are eligible if hepatitis B [HepB] polymerase chain reaction [PCR] is negative).
Patients with active hepatitis B or C. Active hepatitis B is defined as a known positive hepatitis B virus surface antigen (HBsAg) result. Active hepatitis C is defined by a known positive hep C antibody (Ab) result and known quantitative hepatitis C virus (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay.
Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
Positive hepatitis C antibody test result or positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study treatment. NOTE: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
Active human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who have an undetectable HIV viral load with CD4 > 200 and are on highly active antiretroviral therapy (HAART) medication are allowed; subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded; patients who have had hepatitis C but have finished treatment and are PCR negative will be allowed (testing to be done only in patients suspected of having infections or exposures)
Active hepatitis B (HBV) or C (HCV) infection.
Positive hepatitis serology:\r\n* Patients with positive serology for hepatitis B defined as positivity for hepatitis B virus surface antigen measurement (HBsAg) or anti-hepatitis B core total antibodies (antiHBc) may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing hepatitis B virus (HBV) DNA testing by real-time polymerase chain reaction (PCR) monthly during the study\r\n* Patients with positive hepatitis B surface antigen (HBsAg) consistent with prior vaccination to HBV (i.e., hepatitis B immune status/anti-hepatitis B surface antibody [anti-HBs+], anti-HBc-) may participate\r\n* Patients suspected to have false positive serologic studies because of intravenous (IV) immunoglobulin administration are potentially eligible without need for further monitoring if they have negative PCR studies for viral DNA/RNA after discussion with the principal investigator \r\n* Patients with positive hepatitis C serology are excluded unless they have negative hepatitis C virus (HCV) ribonucleic acid (RNA) testing after receiving HCV-specific treatment and the case is discussed with the principal investigator
Hepatitis B virus (HBV): negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or positive HBc and negative HBV deoxyribonucleic acid (DNA) by quantitative PCR
Hepatitis C virus (HCV): negative viral ribonucleic acid (RNA) (if HCV antibody is positive)
Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
Positivity for hepatitis B (defined as HepBs Antigen +), hepatitis C (defined as HepC Antibody +), or HIV; HIV positive patients on antiretroviral therapy will be excluded;
REGISTRATION TO TREATMENT (STEP 1): Patients with a known positive test for hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection might be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with/without active treatment
REGISTRATION TO TREATMENT (STEP 2): Patient with a known positive test for hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment
Active hepatitis B, either active carrier (hepatitis B surface antigen [HBsAg] +) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection. (Patients with past or resolved hepatitis B infection; defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test, are eligible. Patients positive for hepatitis C virus [HCV] antibody are eligible only if polymerase chain reaction [PCR] is negative for HCV ribonucleic acid [RNA].)
For high risk and very high risk CLL-IPI (Arms A and B) only:\r\n* Any of the following:\r\n** Pregnant persons\r\n** Nursing persons\r\n** Persons of childbearing potential who are unwilling to employ highly effective contraception\r\n* Serologic status reflecting active hepatitis B or C infection\r\n** NOTE: Subjects with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before randomization; those who are hepatitis B surface antigen positive or hepatitis B PCR positive and those who are hepatitis C PCR positive will be excluded\r\n* History of stroke or intracranial hemorrhage within 6 months before randomization\r\n* History of bleeding diathesis (e.g. hemophilia, von Willebrand disease)\r\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days of first dose of study drug and while on study\r\n* Requires treatment with a strong CYP3A inducer\r\n* Requires treatment with proton-pump inhibitors (e.g. omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole)\r\n* Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening\r\n* History of confirmed progressive multifocal leukoencephalopathy (PML)\r\n* Received a vaccination with a live vaccine ? 28 days prior to randomization
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (hepatitis B surface antigen [HBsAg] positive), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies); patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C\r\nInfection; Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load
Exclusion criteria based on infectious diseases:\r\n* Active infection requiring IV antibiotics at screening\r\n* Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. HBV deoxyribonucleic acid (DNA) test must be performed in these patients prior to cycle 1 day 1\r\n* Patients with active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\r\n* Known human immunodeficiency virus (HIV) infection\r\n* Influenza vaccination should be given during influenza season. Patients must not receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to cycle 1 day 1 or at any time during the study and for at least 5 months after the last dose of study drug
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities)\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Note:\r\n** Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n** Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies); patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Presence of acute or chronic hepatitis B (hepatitis B virus [HBV]) or active hepatitis C (hepatitis C virus [HCV]). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBV surface antigen [HBsAg]) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\r\n* Patients with past hepatitis B virus (HBV) infection or resolved HBV infection, defined as the presence of hepatitis B core antibody (HBc Ab) and absence of hepatitis B surface antigen (HBsAg) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to day 1 of therapy, but detection of HBV DNA in these patients will not exclude study participation\r\n* Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening)\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive IgG antibody to hepatitis B core antigen [anti-HBc] OR negative hepatitis B virus [HBV] viral load by polymerase chain reaction [PCR]) are eligible
Active hepatitis C\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV ribonucleic acid (RNA)
DONORS: Performance of a donor infectious disease screen panel including cytomegalovirus (CMV) antibody, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus (HIV) 1/2 antibody, human T-cell leukemia-lymphoma virus (HTLV) 1/2 antibody, Treponema, and trypanosoma cruzi (T. Cruzi) plus hepatitis B virus (HBV), hepatitis C virus (HCV), West Nile virus (WNV), HIV by nucleic acid testing (NAT); or per current standard institutional donor screen – must be negative for HIV and active hepatitis B
Active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded; subjects with HIV must have a CD4 count at or above the institutional lower limit of normal and not taking prohibited CYP3A strong inhibitors
Active hepatitis B, either active carrier (hepatitis B surface antigen [HBsAg] +) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >/= 10,000 copies/mL, or >= 2,000 IU/mL).
Tested positive for hepatitis B surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
Human immunodeficiency virus (HIV) positive or evidence of infection with hepatitis B or C virus, as defined by any of the following criteria (if patients have not previously been tested for the following, these will be conducted during screening):\r\n* HIV antibody positive\r\n* Hepatitis B surface antigen or core antibody positive\r\n* Hepatitis C antibody positive
Negative hepatitis B surface antigen
Negative hepatitis C serology
Patients with clinical symptoms of hepatitis B and/or hepatitis C will be tested, if clinically indicated per medical records review; if no indications exist in clinical evaluation or laboratory values that are consistent with hepatitis, patients will not be routinely tested for hepatitis B virus (HBV)/hepatitis C virus (HCV); positive results will be an exclusion criteria
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening. Subjects with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C ribonucleic acid polymerase chain reaction is obtained.
Patients with positive hepatitis B surface antigen (HepBsAg), positive hepatitis total core antibody with negative HBsAG, or detectable hepatitis C virus ribonucleic acid (RNA) by a polymerase-chain reaction (PCR) assay (screening is generally done by hepatitis C antibody (HepCAb), followed by hepatitis C virus RNA by PCR if HepCAb is positive)
Known positive serology for hepatitis C (unless due to immunoglobulin therapy)
Immunocompromised patients, patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) and currently receiving antiretroviral therapy, patients with a prior history of known or suspected autoimmune disease, active hepatitis B virus surface antigen (HBV sAg+), active Hepatitis C (if antibody [Ab]+ then polymerase chain reaction [PCR]+) indicating acute or chronic infection, and/or history of interstitial lung disease
Positive for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) and known history of HIV, malignancy, active infection and cardiovascular diseases (CVs)
Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Positive for hepatitis C virus (HCV) antibody at screening
Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B), positive hepatitis total core antibody with negative HBsAG (suggestive of occult hepatitis B), or detectable hepatitis C virus RNA by a polymerase-chain reaction (PCR) assay (indicative of active hepatitis C – screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive); subjects with hepatitis B virus suppressed on therapy, and previously treated/eradicated hepatitis C virus are eligible for study
Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are not eligible; patients with cleared HBV and HCV (0 viral load) infection will be allowed
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C; patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection\r\n* Individuals with a positive test for HCV antibody but no detection of HCV RNA indicating no current infection are eligible
Subject has know positivity for Hepatitis B surface antigen test or Hepatitis C Antibody
TUMOR BIOPSY SEQUENCING: Patients with uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the past 6 months, invasive fungal infections, or active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e., quantifiable hepatitis B virus [HBV]-DNA and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) are not eligible to participate; testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated
Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
DOSE ESCALATION COHORT: Hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation; hepatitis B virus deoxyribonucleic acid (DNA) and testing for HCV ribonucleic acid (RNA) must be undetectable; at risk for HBV reactivation is defined as hepatitis B surface antigen positive
DOSE EXPANSION COHORT: Hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation; hepatitis B virus DNA and testing for HCV RNA must be undetectable; at risk for HBV reactivation is defined as hepatitis B surface antigen positive
Active hepatitis B virus (HBV; hepatitis B surface antigen [HepBsAG] positive [+ve] and IgM anti-hepatitis B virus core antibody [HBc]), or hepatitis C virus (HCV; detectable HCV ribonucleic acid [RNA]) infection; patients with chronic or cleared HBV and HCV infection are eligible
Patients with active history of any acute or chronic hepatitis, as evidenced by a positive test for hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or a positive test for qualitative hepatitis C viral load by polymerase chain reaction (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\r\n* Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by polymerase chain reaction are eligible\r\n* Subjects with a history of resolved hepatitis A virus infection are eligible
Subjects should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
Hepatitis B (HBV) or hepatitis C (HCV); all patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel; patients with active HBV or hepatitis C infection are not eligible for enrollment; patients with serologic markers of HBV immunization due to known vaccination (hepatitis B surface antigen [HBsAg] negative, anti-hepatitis B core [HBc] negative and anti-hepatitis B surface [HBs] positive) will be eligible
Known serologic status reflecting active hepatitis B or C infection; patients that are hepatitis B core antibody positive, but antigen negative, will need a negative polymerase chain reaction (PCR) prior to enrollment (NOTE: hepatitis B antigen or PCR positive patients will be excluded)
DONOR: Serologies for human immunodeficiency virus (HIV) antigen (Ag), HIV 1 and HIV 2 antibody (Ab), human T-cell lymphotropic virus (HTLV) 1 and HTLV 2 Ab, hepatitis B surface antigen (sAg) or polymerase chain reaction (PCR)+, or hepatitis C Ab or PCR+, syphilis (Treponema) screen and HIV 1 and hepatitis C by NAT (nucleic acid testing) have been collected prior to apheresis
Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) or if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Hepatitis B surface antigen positive
Hepatitis C virus (HCV) antibody positive and detectable HCV quantitative ribonucleic acid (RNA) with clinical evidence of cirrhosis
Known chronic infections with human immunodeficiency virus (HIV), hepatitis B (HBV) or C (HCV); hepatitis B virus DNA and testing for HCV ribonucleic acid (RNA) must be undetectable
A history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (with the exception of cleared HBV and HCV infection, which will be allowed)
Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection-a positive hepatitis B serology indicative or previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Known history of Human Immunodeficiency Virus (HIV) or active Hepatitis B or C. Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and Hepatitis B DNA monitored periodically by the treating physician.
Active hepatitis B or C with uncontrolled disease; NOTE: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B core immunoglobulin M antibody (HBcIgM Ab), hepatitis B surface antigen (HBsAg) and hepatitis C antibody screen (HCV Ab Scrn) w/reflex testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior hepatitis B (HBV) infection
DONOR: Seronegative for human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) polymerase chain reaction (PCR), HIV 1 and HIV 2 antibody (ab), human T-cell lymphotropic virus type (HTLV)-1 and HTLV-2 ab; PCR positive (+) or surface antigen (sAg) hepatitis B; or PCR+ or sAg for hepatitis C; negative for the Treponema palladum antibody syphillis screen; and negative for HIV-1 and hepatitis C by nucleic acid testing (NAT) within 30 days of apheresis collection; in the case that Treponema (T) palladum antibody tests are positive, donors must:\r\n* Be evaluated and show no evidence of syphilis infection of any stage by physical exam and history\r\n* Have completed effective antibiotic therapy to treat syphilis\r\n* Have a documented negative non treponemal test (such as rapid plasma reagin [RPR]) or in the case of a positive non treponemal test must be evaluated by an infectious disease expert to evaluate for alternative causes of test positivity and confirm no evidence of active syphilitic disease
Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment (PCR positive patients will be excluded)
Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection \r\n* NOTE: A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb]-positive and hepatitis B core antibody [HBcAb]-negative), or a fully resolved acute hepatitis B virus infection is not an exclusion criterion
Seronegative for active hepatitis B, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase (RT)-polymerase chain reaction (PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Documented cirrhosis or documented acute hepatitis; Note: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Patients who are hepatitis C virus (HCV) antibody positive and HCV ribonucleic acid (RNA) or hepatitis B virus (HBV) surface antigen positive and HBV DNA positive
Patients who have hepatitis C (both reactive anti-hepatitis C virus [HCV] antibody and detectable HCV RNA) and hepatitis B (hepatitis B surface antigen [HBsAg] positive and anti-hepatitis B core [HBc]-total positive), may be enrolled, provided their total bilirubin: =< 1.5 x institutional upper limit of normal (ULN) AST (SGOT)/ALT (SGPT): =< 2.5 x institutional upper limit of normal
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Active or chronic hepatitis B, hepatitis C or human T-cell lymphotropic virus (HTLV)-I infection; NOTE: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis C core antibody [HBcAb] negative), chronic asymptomatic viral hepatitis or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
DONOR: Performance of a donor infectious disease screen panel including cytomegalovirus (CMV) antibody, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, HIV 1/2 antibody, HTLVA 1/2 antibody, rapid plasma reagin and Trypanosoma cruzi (T. cruzi) or per current University of Minnesota, Fairview Medical Center standard donor screen – must be negative for HIV and active hepatitis B
Patients with evidence of hepatitis C virus (HCV) or hepatitis B virus (HBV) infection must have no clinical evidence of cirrhosis
Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Patients who are human immunodeficiency virus (HIV) positive but have no prior acquired immune deficiency syndrome (AIDS)-defining illness and have cluster of differentiation (CD)4 cells of at least 350/mm^3 are eligible; HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions; patients must not be seropositive for hepatitis B (hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or seropositive for hepatitis C (anti-hepatitis C antibody positive); however, patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests, and if confirmatory tests are negative, the patient can be enrolled
Seronegative for hepatitis C antibody unless antigen negative; if hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA])
Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection; subjects who may not tolerate immune-mediated hepatitis due to compromised hepatic reserve are also excluded from participation including: 1) subjects with extensive liver metastasis (as judged by the investigator) 2) subjects who drink more than two standard alcoholic beverages per day on a regular basis 3) subjects who consume more than 2 grams of acetaminophen per day on a regular basis\r\n* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Cirrhosis, chronic hepatitis C virus positivity, or chronic hepatitis B infection; subjects who may not tolerate immune-mediated hepatitis due to compromised hepatic reserve also excluded from participation including: subjects with extensive liver metastasis (as judged by the investigator); subjects who drink more than two standard alcoholic beverages per day on a regular basis; subjects who consume more than 2 grams of acetaminophen per day on a regular basis\r\n* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb]-positive and hepatitis B core antibody [HBcAb]-negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion
A history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (with the exception of cleared HBV and HCV infection, which will be allowed)
A history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (with the exception of cleared HBV and HCV infection, which will be allowed)
Patients are excluded if they are hepatitis B surface antigen (sAg), hepatitis B (Hep B) core antibody (cAb), or hepatitis C (Hep C) positive; patients with hepatitis B cAB positive and hepatitis B polymerase chain reaction (PCR) negative are eligible if they started prophylactic treatment prior to registration to trial
Active hepatitis B as defined by seropositivity for hepatitis B surface antigen; or patients with positive hepatitis B core antibody titers
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Patients testing positive for human immunodeficiency virus (HIV) titre, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human T-lymphotropic virus (HTLV) I or II antibody, or both rapid plasma reagin (RPR) and fluorescent treponemal antibody (FTA) positive are excluded
Patients testing positive for human immunodeficiency virus (HIV) titre, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human T-lymphotropic virus (HTLV) I or II antibody, or both rapid plasma reagin (RPR) and fluorescent treponemal antibody (FTA) positive are excluded
Adequate performance status (? 70 Karnofsky scale) with an estimated life expectancy\n             of at least 6 months\n\n             --Documented negative hepatitis B screen, per NCCN guidelines (hepatitis B surface\n             antigen/antibodies, core antigen/antibodies, hepatitis B e-antigen)
Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C); note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Presence of hepatitis B surface antigen (HbsAg)
Presence of hepatitis C antibody test (anti-hepatitis C virus [HCV])
Hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody positive with elevated liver transaminases; all patients with chronic active hepatitis (including those on treatment) are ineligible
DONOR: Positive screening test for transfusion-transmissible infection in accordance with DTM or NMDP donation standards, including HIV-positive, hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody positive
Patients must have no evidence of active hepatitis B or C infection (i.e., no positive serology for anti-hepatitis B core [HBc] or anti-hepatitis C virus [HCV] antibodies); hepatitis B virus (HBV) seropositive patients (hepatitis B surface antigen [HBsAg] +) are eligible if HBV deoxyribonucleic acid (DNA) is undetectable at baseline and they are closely monitored for evidence of active HBV infection by HBV DNA testing at each treatment cycle; after completing treatment, HBsAg + patients must be monitored by HBV DNA testing every 2 months for 6 months post-treatment, while continuing lamivudine
Negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy; all participants will be required to be screened for hepatitis B and C; per Infectious Disease Society of America (IDSA) and American Association for the Study of Liver Diseases (AASD) guidelines, those participants that show no immunity, defined by the lack of hepatitis B surface antibody, and show evidence of chronic infection (i.e. hepatitis B surface antigen positive [HBsAg+], hepatitis B core antibody positive [HBcore+], hepatitis surface antibody negative [HBsAB-]) will be required to be on anti-hepatitis B therapy, during the study, in order to be eligible; participants will be permitted to enroll in the study provided liver function tests meet criteria, and there is no evidence of cirrhosis; the exact hepatitis B therapy will be at the discretion of the infection disease specialist or investigator; however all participants who present with acute hepatitis B or show normal transaminases and are HBsAg+ and immunoglobulin (Ig)M+ for hepatitis core antigen will not be eligible for trial enrollment; participants who are hepatitis C antibody positive, with or without a positive hepatitis C RNA level, will be permitted to enroll in the study provided liver function tests meet criteria, and have no evidence of cirrhosis; participants diagnosed with hepatitis C less than 6 months from trial enrollment, will be considered to have acute hepatitis C and will be excluded from study unless hepatitis (hep) C viral load is undetectable
Participants with viral hepatitis who do not meet the criteria will not be eligible; all participants who present with acute hepatitis B including those with normal transaminases who are HBsAg+ and IgM + for hepatitis core antigen will not be eligible; participants who are hepatitis B core antibody positive are eligible only if they start or are on prophylactic therapy; a hepatitis B viral load should be confirmed negative on all participants who are hepatitis B core antibody positive, but hepatitis B antigen negative; participants refusing to take any anti-hepatitis B therapy during study will also be excluded; participants diagnosed with hepatitis C are eligible if they meet criteria
Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection
Positive tests for hepatitis B virus surface antigen (HBV SAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection (hepatitis C antibody test will be the primary test, and the RNA testing will only be used to confirm a positive antibody test)
Chronic active hepatitis B; patient may be hepatitis B core antibody positive; for patients with concomitant positive hepatitis B surface antigen, patient will require a hepatology consultation; the risk/benefit profile of transplant and hepatitis B will be discussed with the patient and eligibility determined by the principal investigator and LAI
Hepatitis B virus (HBV) or untreated systemic infection
Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have a history of hepatitis C. Participants who completed treatment for hepatitis C at least 6 months prior to screening and have no detectable circulating hepatitis C virus (HCV) at screening, may participate in the study. Such participants will be required to undergo regular assessment for HCV reactivation during their participation in the study. Participants who test positive for HCV at any time during these assessments will be withdrawn from the study
Patients must not have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed
Has known history of chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (detectable HCV RNA)
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.
Has controlled infection by Hepatitis B Virus (HBV).
Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
Participant is known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg] or antibodies to hepatitis B surface and core antigens [anti-HBs and anti-HBc, respectively]) or hepatitis C (anti-HCV antibody positive or HCV-ribonucleic acid [RNA] quantitation positive)
Participants with past or resolved hepatitis B virus (HBV) infection are eligible; participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV Riboxy Nucleic Acid (RNA).
CLINICAL/LABORATORY CRITERIA: Patients must not have a known history of active hepatitis B or C infection (defined as presence of hepatitis [Hep] B surface antigen [sAg] and/or Hep B deoxyribonucleic acid [DNA] and/or Hep C ribonucleic acid [RNA]); patients must not have a known history of human immunodeficiency virus (HIV) seropositivity
Active autoimmune disease; other CNS autoimmune disease. Known seropositive for human immunodeficiency (HIV) virus, hepatitis B surface antigen (HbsAg), or antibody to hepatitis C virus (anti-HCV) with confirmatory testing and requiring anti-viral therapy.
Uncontrolled hepatitis B virus (HBV) infection, defined as plasma HBV DNA detectable by polymerase chain reaction (PCR)\r\n* Note: the following will NOT be exclusionary:\r\n** A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute HBV infection\r\n** Patients with chronic HBV suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in DHHS guidelines
Uncontrolled hepatitis C virus (HCV) infection, defined as plasma HCV RNA detectable by PCR\r\n* Note: the following will NOT be exclusionary:\r\n** Positive HCV serology but no detectable HCV RNA, indicative of spontaneously cleared HCV infection\r\n** Patients who have been successfully treated for HCV as long as therapy for HCV has been completed
Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (hepatitis B surface antigen [HBV sAg]) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection
Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is required: this includes hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody (HBcAb) in addition to HCV antibody testing; the most recent serologic testing must have occurred within 12 weeks prior to registration; if such testing has not been done, it must be performed during screening\r\n* Note: patients who have positive HBV (i.e., HBsAg or HBcAb) or HCV serologies without known active disease must meet the eligibility criteria for ALT, AST, total bilirubin (TBILI), INR, activated partial thromboplastin time (aPTT)/PTT, and alkaline phosphatase (ALP) on at least two consecutive occasions, separated by at least 1 week, within the 30-day screening period; the second of these evaluations must be performed within 3 days prior to the first treatment administration
Patients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C); NOTE: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) and hepatitis C virus (HCV) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Known history of HIV or AIDS; or positive test for hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg)
Subject who tests positive for hepatitis B surface antigen (HBVsAg) or hepatitis C RNA indicating acute or chronic infection except for subjects with hepatocellular carcinoma;
Hepatitis C virus (HCV) antibody positive
Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening
Positive Hepatitis B surface antigen test
Positive Hepatitis C antibody test
Subjects with a history of Hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by the protocol and are hepatitis B surface antigen negative and/or have undetectable HCV RNA.
Active hepatitis B or C as evidenced by detection of virus specific Deoxyribonucleic Acid (DNA) or Ribonucleic Acid (RNA).
Hepatitis B or C positive
Patients who are known hepatitis B surface antigen-positive are not eligible
Patients who have known or suspected active hepatitis C infections are not eligible; NOTE: patients who are hepatitis C surface antigen-positive are eligible
Part A: Known history of testing positive for HIV or known acquired immunodeficiency syndrome (AIDS) or any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. For Part B, known history of testing positive for HIV or known AIDS in consultation with the Medical Monitor or HBV or HCV infection at screening (positive HBV surface antigen or HCV RNA if anti- HCV antibody screening test positive).
Primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus or solid organ transplant. History of known HIV. History of known Hepatitis B surface antigen or positive Hepatitis C antibody (confirmed by RIBA).
Has known history of chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (detectable anti-hepatitis C circulating viral RNA)
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
HIV, active hepatitis B (HBV) or active hepatitis C (HCV)\r\n* Patients with past HBV infection or resolved HBV infection, defined as the presence of hepatitis B core antibody (HBc Ab) and absence of hepatitis B surface antigen (HBsAg) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to day 1 of ibrutinib therapy, but detection of HBV DNA in these patients will not exclude study participation\r\n* Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
Active hepatitis C infection as determined by hepatitis C RNA; A subject who is HCV antibody positive will be screened for HCV RNA by any RT polymerase chain reaction (PCR) or bDNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.
positive hepatitis B and/or C serology.
Hepatitis B surface antigen (HBsAg) positive
Subjects who are seropositive because of HBV vaccination are eligible (HBV surface antibody positive, HBV core antibody negative, and HBV surface antigen negative)
No evidence of active hepatitis B or C infections (hepatitis B surface antigen positive [HBsAg +], hepatitis B deoxyribonucleic acid [DNA] positive by polymerase chain reaction [PCR], or anti-hepatitis C virus [HCV] antibodies); hepatitis core antibody (HBcAb) seropositive patients that are HBsAg negative are eligible if they are closely monitored for evidence of active hepatitis B virus (HBV) infection by HBV DNA testing and receive suppressive therapy with lamivudine or other HBV suppressive therapy until 6 months after the last rituximab dose
Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment; (PCR positive patients will be excluded)
Known to be positive for hepatitis B by surface antigen expression and hepatitis B core antibody
Except in cohort 3, HPV-associated cancers, active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV deoxyribonucleic acid (DNA) test at screening, are eligible for the study
Except in cohort 3, HPV-associated cancers active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening; the HCV RNA test will be performed only for patients who have a positive HCV antibody test
Hepatitis B surface Antigen (HBsAg) positive
Hepatitis C virus (HCV) antibody positive with HCV RNA positive
Positive tests for hepatitis B virus surface antigen (HBV SAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection
Subject who is seropositive for or active viral infection with hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive and/or detectable viral DNA)
Has untreated active Hepatitis B virus (HBV)
For Cohort 1: has dual infection with HBV/Hepatitis C virus (HCV) or other hepatitis combinations at study entry
For Cohort 2: has dual active HBV infection (Hepatitis B surface antigen positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV infection (detectable HCV ribonucleic acid [RNA]) at study entry
Negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc) antibody or undetectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (PCR) testing
Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA) by quantitative PCR
Known hepatitis B surface antigen seropositive, or known or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (that is, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load.
Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV); patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Patients with treated hepatitis virus infections (hepatitis B or hepatitis C) are eligible if they have been definitively treated for 6 months, have no detectable viral load on quantitative PCR, and liver function tests (LFTs) meet eligibility requirements
Presence of positive test results for hepatitis B (hepatitis B surface antigen [HbsAg] and/or total hepatitis B core antibody [anti-HBc]) or hepatitis C (hepatitis C virus [HCV] antibody)
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) except in patients with HCC, who meet the following criteria:
Patients must be screened for HCV. Patients must have negative hepatitis C antibody (HCV Ab) or are HCV Ab positive but with an undetectable level of HCV-RNA. Note: patients with detectable HCV-RNA are not eligible for the study.
Patients with active hepatitis B or C. Screening for hepatitis B Prior to randomization/start of everolimus, the following three categories of patients should be tested for hepatitis B viral load and serologic markers, that is, HBsAg, HBcAb, HBsAb and quantitative hepatitis B DNA PCR (HBV-DNA): • All patients who currently live in (or have lived in) Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal and Greece. [http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-related-to-trave l/hepatitis-b.htm]
Additional patients at the discretion of the investigator The management guidelines, in Section 6, are provided according to the results of the baseline assessment of viral load and serological markers for hepatitis B. Screening for hepatitis C Patients with any of the following risk factors for hepatitis C should be tested using quantitative RNA-PCR:
Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) or Human Immunodeficiency Virus (HIV)
Positive serology for hepatitis C based on test at screening.
Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection with HCV hepatitis requiring anti-viral medication (at time of randomization).
Patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of hepatitis B DNA are not eligible for this study; patients with a positive hepatitis B core antibody but with negative hepatitis B DNA may participate, but must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician\r\n* Intravenous immunoglobulin (IVIG) can cause a false positive hepatitis B serology; if patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, but should have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician
Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)
Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
Known to be positive for hepatitis B surface antigen or hepatitis B core antibody; if hepatitis B (HBV) deoxyribonucleic acid (DNA) test is known to be negative, patients seropositive for HBV core antibody (and seronegative for HBV surface antigen) are eligible; NOTE: Does NOT need to be repeated if pre-transplant screening test was negative
Positive test results for chronic hepatitis B infection and hepatitis C virus (HCV)
Negative serology for active hepatitis B and C for anakinra arm. Patients with positive serology for hepatitis B might eligible if they are willing to take lamivudine preventive therapy.
DONOR: Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors; tests include but are not limited to: hepatitis B surface antigen (HepBsAg), hepatitis B surface antibody (HepBsAb), hepatitis B core antibody (HepBcAb), hepatitis C (HepC) antibody, human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV) I and II, varicella zoster virus (VZV), cytomegalovirus (CMV) and Venereal Disease Research Laboratory (VDRL), West Nile virus and Chagas screen; donor must have normal negative test results for HIV, HTLV I and II, and West Nile virus; donor exposure to other viral pathogens will be discussed on a case-by-case basis by the investigators
Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B), positive hepatitis total core antibody with negative HBsAG (suggestive of occult hepatitis B), or detectable hepatitis C virus ribonucleic acid (RNA) by a polymerase-chain reaction (PCR) assay (indicative of active hepatitis C – screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive)
Patients with active hepatitis B virus (HBV, chronic or acute, defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C antibody \r\n* Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to cycle 1, day 1 and confirmed to be negative\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
For patients with positive hepatitis B core antibody or surface antigen, hepatitis B polymerase chain reaction (PCR) must be negative and prophylaxis with entecavir or equivalent is required
Any positive test result for hepatitis B or C indicating acute or chronic infection
Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded
Known chronic hepatitis B or C (HBV/HCV) infection.
Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection
Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)
Participants with active viral hepatitis (positive hepatitis B surface antigen [HepB sAg], positive HepB core antibody [Ab] with positive hepatitis B [HepB] viral load, or positive hepatitis C [HepC] antibody with positive HepC viral load)
Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV, as determined by enzyme-linked immunosorbent assay [ELISA] and confirmed by western blot) and hepatitis B and hepatitis C virus (HBV/HCV, as determined by hepatitis B surface antigen [HBsAg] and hepatitis C serology)
Specific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on hepatitis B serological testing as follow:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B virus core antibody (HBcAb) negative, hepatitis B virus surface antibody (HBsAb) negative patients are eligible\r\n* HBsAg negative, HBcAb negative, HBsAb positive patients are eligible\r\n* Patients who test positive for HBsAg are ineligible\r\n* Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing performed and protocol eligibility determined as follow:\r\n** If HBV DNA is positive, the subject is ineligible\r\n** If HBV DNA is negative, the subject may be included but must undergo HBV DNA polymerase chain reaction (PCR) testing monthly x 3 months beginning from the start of treatment
Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody\r\n* Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\r\n* Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable; these patients must be willing to undergo monthly DNA testing
Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\r\n* Hypertension that is not controlled on medication (defined as >= 140/100 at rest, average of 3 consecutive readings)\r\n* Ongoing or active infection requiring systemic treatment\r\n* Symptomatic congestive heart failure\r\n* Unstable angina pectoris\r\n* Cardiac arrhythmia\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Known positive test for human immunodeficiency virus (HIV)\r\n* Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\r\n* Active tuberculosis\r\n* Prior allogeneic bone marrow transplantation or solid organ transplant\r\n* Administration of a live, attenuated vaccine within 4 weeks before starting the study treatment or anticipation that a live attenuated vaccine will be required during the study\r\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints
Active hepatitis B, defined by a positive test for hepatitis B surface antigen [HBsAg] or prior history of hepatitis B, defined by presence of antibodies to hepatitis B core antigen [anti-HBc], regardless of hepatitis B surface antibody [anti-HBs] status; active hepatitis C or prior history of hepatitis C (anti-HCV positive), except in the setting of a sustained virologic response (SVR), defined as aviremia 12 weeks after completion of antiviral therapy. If hepatitis C virus (HCV) antibodies are detected, an HCV RNA test for viral load by polymerase chain reaction (PCR) should be performed at least 12 weeks after completion of antiviral therapy to rule out active infection Exclusion Criteria for Crossover:
Liver disease such as cirrhosis or severe hepatic impairment (patient with a Child-Pugh score B or\r\nC). A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
Patients should be excluded if they test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Patients are excluded if they test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests (hepatitis B [Hep B] deoxyribonucleic acid [DNA] quantitative [Quant], hepatitis B virus [HBV] viral load), and if confirmatory tests are negative, the patient can be enrolled
Seronegative for hepatitis C antibody unless antigen negative; if hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by hepatitis C (Hep C) ribonucleic acid (RNA) quant, hepatitis C virus (HCV) viral load and be HCV RNA negative
Patients are not eligible if they have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute infection; Note: Patients with evidence of chronic hepatitis B infection will be allowed to enroll if on appropriate suppressive medications under the direction of a hepatologist and with PI approval
Positive hepatitis B virus (HBV) surface antigen, or core antibody; and known or suspected active hepatitis C virus (HCV) infection, for the idelalisib arm; on the ibrutinib arm, patients with positive hepatitis B surface antigen may be appropriately treated and enrolled on this study as long as their HBV deoxyribonucleic acid (DNA) / viral load is undetectable; patients positive for hepatitis B (hepB) core antibody and negative for surface antigen are eligible for the ibrutinib arm, as are patients with hepatitis C
Patient has acute viral hepatitis (typically defined by elevated AST/ALT), or a history of chronic or active hepatitis B virus (HBV) or hepatitis c virus (HCV) infection; HBV infection is defined as having hepatitis B surface antigen (HBsAg) and/or hepatitis B virus core antibody (HBcAb) positive test with concurrent detectable HBV deoxyribonucleic acid (DNA) levels; HCV infection is defined as detectable HCV ribonucleic acid (RNA) levels
Active infection; positive for hepatitis B surface agent (HbsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening; known history of HIV positive status, progressive multifocal leukoencephalopathy (PML), autoimmune disease
Subjects with serologic status reflecting active viral hepatitis B or C infection are not eligible\r\n* Subjects who are hepatitis B core antibody positive but antigen negative will need negative polymerase chain reaction (PCR) prior to enrollment; hepatitis B surface antigen positive or PCR positive patients will be excluded\r\n* Subjects who are hepatitis C antibody positive will need negative PCR prior to enrollment; patients with positive hepatitis C will be excluded
Patients who test positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. History of known HIV infection. NOTE: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) polymerase chain reaction (PCR) is obtained.
Known history of human immunodeficiency virus (HIV), active infection with hepatitis B virus (HBV), and/or hepatitis C virus (HCV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months) or with a history of human immunodeficiency virus (HIV) disease
For gastric/GEJ and NSCLC participants, has chronic hepatitis B or hepatitis C infection. (For HCC participants, those with chronic hepatitis B virus [HBV] infection with a negative HBV deoxyribonucleic acid [DNA] test and who are on antiviral therapy, and those with chronic hepatitis C virus [HCV] infection are eligible)
Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B virus surface protein antigen (HBsAg) or anti-hepatitis B virus core antibody (HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management
Hepatitis C virus (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection; patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible; patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for hepatitis C virus ribonucleic acid (HCV RNA)
Any positive test result for hepatitis B or C virus indicating acute or chronic infection
Patient is hepatitis C virus (HCV) antibody (Ab) positive or hepatitis B surface antigen (HBSAg) positive
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Known history of human immunodeficiency virus (HIV), chronic hepatitis B virus (HBV), or active hepatitis C virus (HCV); Note: subjects with serologic evidence of prior vaccination to HBV (i.e., hepatitis B surface antigen negative [HBs Ag-], hepatitis B virus core antibody negative [anti-HBc-]) and positive anti-HBc from intravenous immunoglobulin (IVIG) may participate
Positive hepatitis serology:\r\n* Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n** Patients with positive HBSAg consistent with prior vaccination to HBV (i.e., anti-HBs+, anti-HBc-) may participate\r\n** Patients suspected to have false positive serologic studies because of IV immunoglobulin administration are potentially eligible after negative PCR studies for viral DNA/ribonucleic acid (RNA) and discussion with the principal investigator\r\n* Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV RNA is confirmed negative and may be considered for inclusion in the study on a case-by-case basis (e.g., patients with negative viral load after HCV-specific treatment)
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
For patients with unknown hepatitis B virus surface antigen (HbsAg) status, must be tested during study screening; patients who are tested positive test for HBsAg are excluded if they have inadequately controlled hepatitis B and/or Child-Pugh Class B or C cirrhosis; however, patients with adequately controlled hepatitis are not excluded from the study if they satisfy all of the following criteria: (i) must be receiving a nucleoside analog anti-viral drug for 3 or more months; and (ii) have a serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level of less than 100 IU/ml via polymerase chain reaction quantification assays prior to enrollment
For patients with unknown hepatitis C virus ribonucleic acid (HCV antibody) status, must be tested during study screening; patients who are tested positive for HCV antibody are excluded from the study if they have inadequately controlled hepatitis C and/or Child-Pugh Class B or C cirrhosis; patients with adequately controlled hepatitis are not excluded from the study as defined by having undetectable level of serum HCV antibody level prior to enrollment; patients who are currently on interferon or other anti-HCV therapy will be excluded from study
Positive hepatitis serology: (a) Participants with positive serology for hepatitis B, defined as positivity for hepatitis B surface antigen (HBsAg), or participants who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive, (b) Participants positive for anti-HBc, but with negative hepatitis B Virus (HBV) deoxyribonucleic acid (DNA), will be considered for inclusion by the Medical Monitor on a case-by-case basis in order to ensure feasibility of monthly DNA testing and availability of appropriate care in case of hepatitis B reactivation, (c) Participants with positive serology for hepatitis C (HCV) unless HCV (by ribonucleic acid [RNA]) is confirmed negative
All patients must be willing to be tested for hepatitis screening; patients co-infected with hepatitis B virus and/or hepatitis C virus may be included in this study provided that their liver function tests remain within the limits listed above; patients must be followed by a hepatologist during the course of this study
Patient has acute viral hepatitis or a history of chronic or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Active and chronic viral hepatitis (i.e. quantifiable serum hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B virus surface antigen [HBsAg], or quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA] in serum)
Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive because of hepatitis B virus vaccine are eligible; patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Have received a diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (patients who are hepatitis C antibody positive may be enrolled if they are confirmed with negative viral load at screening)
Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
Evidence of active acute or chronic hepatitis B (hepatitis B virus [HBV]): subjects with acute or chronic active HBV will be defined based on Centers for Disease Control and Prevention (CDC) guidelines; this will include subjects with positive serology for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc) associated with HBV-deoxyribonucleic acid (DNA) positive test by real time quantitative polymerase chain reaction (qPCR) assessment; subjects, who are anti-HBc positive and HBsAg negative or HBV-DNA test negative, may be enrolled in the study and should undergo regular monitoring of HBV viral load using HBV-DNA qPCR; those subjects may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management including antiviral therapy
Evidence of active hepatitis C (hepatitis C virus [HCV]): subjects with positive hepatitis C serology AND positive HCV ribonucleic acid (RNA) test
Positive Hepatitis B surface antigen test
Subjects with serologic status reflecting active viral hepatitis B or C infection are not eligible; subjects that are hepatitis B core antibody positive but antigen negative will need negative polymerase chain reaction (PCR) prior to enrollment; PCR-positive patients will be excluded
Patients with a history of alcohol abuse, chronic hepatitis, or other chronic liver disease (other than direct CLL liver involvement); NOTE: chronic hepatitis includes active infection with hepatitis B or C; all patients will be tested for hepatitis C virus antibodies (HCV Ab) and hepatitis B surface antigen (HBsAg) at screening; patients with a positive result for HBsAg or HCV Ab will be excluded from enrolling in this study
Positive serology for hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg); in addition, if negative for HBsAg but HB core antibody (HBcAb) positive (regardless of HB surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded\r\n* If HB virus (HBV) DNA is negative, subject may be included but must undergo HBV DNA polymerase chain reaction (PCR) testing at least every 2 months from the start of treatment until 12 months post treatment; prophylactic antiviral therapy may be initiated at the discretion of the investigator
Patients must not have any of the following conditions:\r\n* Congestive heart failure or New York Heart Association Functional Classification III or IV congestive heart failure\r\n* History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration\r\n* Recent infections requiring systemic treatment; need to have completed anti-biotic therapy > 14 days before the first dose of study drug\r\n* Cerebral vascular accident or intracranial bleed within the last 6 months\r\n* Infection with known chronic, active hepatitis C\r\n* Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment (PCR positive patients will be excluded)
Active hepatitis B as defined by hepatitis B surface antigen positivity, unless able to start dual anti-hepatitis B (HepB) therapy, or already on dual anti-HepB therapy
Patients who are positive for hepatitis B core antibody, but negative for the hepatitis B surface antigen, should be on lamivudine 100 mg daily until at least 3 months post-transplant
Known history of human immunodeficiency virus or active hepatitis C virus (HCV; ribonucleic acid [RNA] polymerase chain reaction [PCR]-positive) or active hepatitis B virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection requiring intravenous antibiotics
Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result within 3 months prior to first dose of study treatment. Subjects with positive Hepatitis C antibody due to prior exposure can be enrolled, only if a confirmatory negative Hepatitis C RNA polymerase chain reaction (PCR) test is obtained.
Active hepatitis B or C infection\r\n* Patients with hepatitis B virus (HBV) core antibody positive, but HBV polymerase chain reaction (PCR) negative are eligible if they are on medication for suppression of HBV reactivation\r\n* Patients with hepatitis C virus (HCV) antibody positive, but PCR negative are eligible
History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Positive HBV or HCV test indicating acute or chronic infection.
Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\r\n* Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load; patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute or chronic infection (if patient has documented hepatitis B and C from within 6 months of enrollment, these tests do not need to be repeated)
Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAG), or hepatitis C antibody, must have a negative polymerase chain reaction (PCR) prior to enrollment; (PCR positive patients will be excluded)
Active hepatitis C. Patients will be screened for HCV antibody. If the HCV antibody is positive, a screening HCV RNA by any RT PCR or bDNA assay must be performed at screening by a local laboratory with a CLIA certification or its equivalent. Eligibility will be determined based on a negative screening value. The test is not required if documentation of a negative result of a HCV RNA test performed within 60 days prior to screening is provided.
Serologic status reflecting active hepatitis B or C infection; patients that are hepatitis B core antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment; PCR positive patients will be excluded
Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies (HCV Ab) or hepatitis B surface antigen (HBsAg) or hepatitis B core antibodies (HBcAb)
History of hepatitis B or C; Note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) serology, DNA and/or hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection; if no positive medical history for risk factors, serology is not required
Seropositivity or DNA/RNA positivity for hepatitis B or C, with the exception of patients who have received prior Hepatitis B vaccination and are Anti-HBs positive only
Patients who test positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
Hepatitis B with positive viral load prior to transplant conditioning or hepatitis C virus
Positive anti-hepatitis B virus (HBV); HBV seropositive patients (hepatitis B surface antigen [HBsAg] positive) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxyribonucleic acid (DNA) testing, and they must agree to receive suppressive therapy with lamivudine or other HBV-suppressive therapy until at least 4 weeks after the last dose of everolimus; patients who are anti-hepatitis C virus (HCV) positive are eligible provided that hepatitis C viral load (hepatitis C ribonucleic acid [RNA]) is undetectable
Known human immunodeficiency virus (HIV), hepatitis B or C infection (with the exception of chronic or cleared hepatitis B virus [HBV] and hepatitis C virus [HCV] infection which will be allowed provided the following tests are done at screening: viral hepatitis serology, hepatitis B surface antigen and hepatitis B core antibody [immunoglobulin M (IgM)] and/or hepatitis C ribonucleic acid [RNA])
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B virus surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; HBsAg negative, HBsAb negative, HBsAb positive subjects can be included\r\n* Consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive\r\n* Monitoring criteria for HBcAb+ and HBV DNA negative subjects:\r\n** If HBV DNA is negative, subject may be included but must undergo at least every 2 month HBV DNA polymerase chain reaction (PCR) testing from the start of treatment during the treatment course\r\n** Monitoring during the follow-up period will be performed during routine study visits for a minimum follow-up period of six months after the last dose, as long as the subject remains on study; monitoring frequency during follow-up should occur at a minimum of every 2-3 months; whenever possible, the monitoring should occur as part of the routine follow-up visit (Note: for most studies, the follow-up visits are 1 month post-dose, 3 months post-dose and 6 months post-dose\r\n** Prophylactic antiviral therapy may be initiated at the discretion of the investigator
Patient must not have a history of positive hepatitis C serology
HAPLO-IDENTICAL DONOR: Evidence of active infection (including active urinary tract infection, or upper respiratory tract infection) or evidence of viral hepatitis exposure on screening unless only hepatitis B surface antibody (HbsAB)+ and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) negative
Clinically active hepatitis B defined as positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) viral load; patients who are HBcAb with undetectable HBV DNA viremia are eligible
Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb) and confirmed by HC recombinant immunoblot assay (RIBA) or hepatitis C virus (HCV) ribonucleic acid (RNA) viral load
Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV RNA.
Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA.
HIV infection or active hepatitis B (defined as hepatitis B surface antigen positive) or C (defined as hepatitis C antibody positive)
Known human immunodeficiency virus (HIV) positive, or active hepatitis A, hepatitis B or hepatitis C; if hepatitis B surface antigen positive or B core antibody positive must have normal liver function tests and be willing and able to take anti-hepatitis medication such as lamivudine or equivalent
Active infections including hepatitis B and hepatitis C; definition of active hepatitis C infection include:\r\n* Positive hepatitis C virus (HCV) ribonucleic acid (RNA) viral load by quantitative polymerase chain reaction (PCR) testing or if negative HCV RNA viral load BUT on antiviral treatment\r\n* Liver biopsy with pathologic evidence of \r\n** Necrosis and inflammation around the portal areas - piecemeal necrosis or interface hepatitis or necrosis of hepatocytes and focal inflammation in the liver parenchyma\r\n** Inflammatory cells in the portal areas (\portal inflammation\)\r\n** Fibrosis, with early stages being confined to the portal tracts, intermediate stages being expansion of the portal tracts and bridging between portal areas or to the central area, and late stages being frank cirrhosis characterized by architectural disruption of the liver with fibrosis and regeneration
DONOR: Evidence of active infection (including urinary tract infection, or upper respiratory tract infection) or viral hepatitis exposure (on screening), unless only hepatitis B surface antibody positive (Hbs Ab+) and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) negative
Hepatitis B carrier status history of hepatitis B virus (HBV) or positive serology; a patient is considered as HBV carrier or to have (had) HBV infection in case of: \r\n* Unimmunized and hepatitis B surface antigen (HBsAg) and/or anti-HBs antibody and/or anti- HBc antibody positive,\r\n* Immunized and HBsAG and/or anti-HBc antibody positive\r\n** Important note: for the phase III trial, a patient without a known history of hepatitis B could be randomized in the study if the serology results are not available at the time of the randomization; however, if the serology results are positive or not available at day 6 (the first day would be due to receive rituximab, if so randomized), the patient must be withdrawn from the study whatever the allocated treatment arm; the data center must be informed immediately; for the phase II trial, the hepatitis B serology results must be available before registration; in each case indicating a carrier status or history for hepatitis B infection, the patients must not receive rituximab, and therefore must not be included in the rituximab trials on any treatment arm; in case of high-risk patients, the recommendation is to treat these patients with the standard LMB regimen corresponding to the patient prognostic group; in the case of PMLBL the physician is left to choose the most appropriate therapy
A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B virus surface antibody [HBsAb] positive and hepatitis B virus core antibody [HBcAb] negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg) and a detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) viral load; if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HBV DNA test will be performed and if positive the subject will be excluded; if HBV DNA is negative, subject may be included but must undergo at least every 2-month HBV DNA polymerase chain reaction (PCR) testing from the start of treatment during the treatment course; prophylactic antiviral therapy may be initiated at the discretion of the investigator
Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb), in which case reflexively perform a hepatitis C virus (HCV) PCR to confirm the result
Specific guidelines will be followed regarding inclusion of MCL based on hepatitis B serological testing as follows:\r\n* Hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) negative, hepatitis B surface antibody (HBsAb) positive MCL patients are eligible\r\n* Patients who test positive for HBsAg are ineligible (regardless of other hepatitis B serologies)\r\n* For MCL patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status), should have hepatitis B virus (HBV) deoxyribonucleic acid (DNA) testing done and protocol eligibility determined as follows:\r\n** If HBV DNA is positive the subject is excluded\r\n** If HBV DNA is negative, patient may be included but must undergo at least every 2 months HBV DNA polymerase chain reaction (PCR) testing from the start of treatment throughout the duration the study\r\n** Monitoring during the study is required at least every 2 months and during follow-up at a minimum of every 2-3 months up to 6 months after the last dose\r\n** Prophylactic antiviral therapy with lamivudine (3TC) or investigator’s preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter may be initiated at the discretion of the investigator\r\n** If the patients’ HBV DNA becomes positive during the study, the investigator should manage the clinical situation as per the standard of care of participating institution; the investigator should weigh the risks and benefits of continuing ofatumumab or discontinuing ofatumumab before appropriate treatment decisions are made for that individual patient
Consult with a physician experience in care and management of subjects with hepatitis B to manage/treat subjects who are anti-hepatitis B core antibody (HBc) positive
Positive serology for hepatitis B (HB) defined as a positive test for HBsAg; in addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a hepatitis B DNA test will be performed and if positive the patient will be excluded
Individuals with a documented history of previous or current hepatitis B or C infection; hepatitis B or C serologic screening is not required prior to enrollment, except in participants with any of the following high-risk features:\r\n* Suspected (but not documented) previous hepatitis B or C infection\r\n* Blood transfusion(s) prior to 1990\r\n* Current or prior IV drug use\r\n* Current or prior dialysis\r\n* Household contact with hepatitis B or C infected individual\r\n* Mother with known hepatitis B or C infection\r\n* Current or prior high-risk sexual activity\r\nFor participants with any of the above high risk features: study enrollment will only be allowed if hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) or hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV)-ribonucleic acid (RNA) polymerase chain reaction (PCR) are negative within 14 days prior to study enrollment; any patient with a positive result on any of these screening tests is ineligible
Patients must have negative antibody serology for the human immunodeficiency virus (HIV1 and 2) and hepatitis C virus and negative test for hepatitis B surface antigen
DONOR: Donors must not be seropositive for HIV 1 and 2, hepatitis B surface antigen, hepatitis B core antibody, human T-lymphotropic virus (HTLV) antibody, cytomegalovirus (CMV) immunoglobulin (Ig)M, or rapid plasma reagin (RPR) (Treponema)
DONOR: Donors must not be newly seropositive for hepatitis B core antibody since the original HCT; donors with prior evidence of hepatitis B core antibody positivity will have a polymerase chain reaction (PCR) test done to evaluate for hepatitis B infection; donors with a positive hepatitis (Hep) B PCR test will be excluded
Hepatitis B carrier status history of HBV or positive serology.
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B virus HBsAg surface protein antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B virus core antibody (HBcAb) positive and hepatitis B surface antibody (HBsAb) negative, a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; Note: if patient HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included; patients who are seropositive because of hepatitis B virus vaccine are eligible; consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive
Patients with known hepatitis B surface antigen (HBsAg) positive hepatitis B virus (HBV) infection; patients with prior history of hepatitis B infection, but immune, with only immunoglobulin G (IgG) hepatitis core antibody positive (HBcAb +) must receive anti-viral prophylaxis (e.g., lamivudine 100 mg orally [PO] daily) for at least 1 week prior to cycle 1 and throughout induction and continuation therapy and for at least 6 months after the last brentuximab vedotin dose; in addition, consultation with a hepatologist is recommended
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); patients with prior history of hepatitis B infection, but immune, with only immunoglobulin (Ig)G hepatitis core antibody + (HBcAb +) must be checked for hepatitis B virus titers by polymerase chain reaction (PCR) and if the viral load is undetectable may be enrolled; these patients must receive anti-viral prophylaxis, such as lamivudine 100 mg orally (PO) daily (or an equivalent) starting at least one week prior to cycle 1 and continued through the completion of treatment and for 9 months after the last dose of ofatumumab; hepatitis B virus titers by quantitative PCR and HBsAg should be checked every month (+/- 1 week) while on therapy and every 3 months (+/- 1 month) thereafter for 9 months after the last ofatumumab dose; in the event of an early termination of the clinical trial for any reason, a treating physician will be determining the frequency and the length of follow up studies of hepatitis B virus titers and HBsAg status; it is recommended that the patient remains on prophylactic lamivudine or an equivalent, as above, regardless of whether the study was continued or terminated; in addition, if appropriate consultation with a hepatologist should be obtained
Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HGsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive
Active Hepatitis C. Patients will be screened for HCV antibody. If the HCV antibody is positive, a screening HCV RNA by any RT-PCR or bDNA assay must be performed at screening by a local laboratory with a CLIA certification or its equivalent. Eligibility will be determined based on a negative screening value. The test is not required if documentation of a negative result of a HCV RNA test performed within 60 days prior to screening is provided.
Positive serology for human T-lymphotropic virus (HTLV) I, human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection including a positive hepatitis B serology indicative of previous immunization (i.e. hepatitis B surface antibody [HBs Ab] positive and hepatitis B core antibody [HBc Ab] negative)
Chronic active hepatitis B infection; patients may be hepatitis B core antibody positive but must be surface antigen negative and without active evidence of disease
Known Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection. Subjects with laboratory evidence of cleared HBV and HCV infection may be enrolled;
Subjects who have current active hepatic (hepatitis B-virus surface antigen [HbsAg], hepatitis B-virus core antibody [HbcAb], and positive viral load by polymerase chain reaction [PCR]) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) (consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive)
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* Severely impaired lung function, defined as spirometry and diffusion lung capacity for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is =< 88% at rest on room air\r\n* Uncontrolled diabetes, defined as fasting serum glucose > 1.5 x ULN (Note: optimal glycemic control should be achieved before starting trial therapy)\r\n* Active (acute or chronic) or uncontrolled severe infections\r\n* Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n** Note: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection; testing for hepatitis B viral load and serologic markers (HBV-DNA, hepatitis B virus surface antigen [HBsAg], hepatitis B virus surface antibody [HBs Ab], and hepatitis B virus core antibody [HBc Ab]) and HCV RNA PCR are required at screening for all patients in the following risk categories:\r\n* All patients who currently live in (or have lived in) Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal, and Greece\r\n* Patients with any of the following risk factors:\r\n** Known or suspected past hepatitis B infection\r\n** Blood transfusion(s) prior to 1990\r\n** Current or prior IV drug users\r\n** Current or prior dialysis\r\n** Household contact with hepatitis B infected patient(s)\r\n** Current or prior high-risk sexual activity\r\n** Body piercing (other than ears) or tattoos\r\n** Mother known to have hepatitis B\r\n** History suggestive of hepatitis B infection e.g., dark urine, jaundice, right upper quadrant pain\r\n* Additional patients at the discretion of the investigator
Arms A, C and D: Patient has acute viral hepatitis or a history of chronic or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, (typically defined by elevated AST/ALT (persistent or intermittent), high HBV deoxyribonucleic acid [DNA] level, HBsAg positive, or high HCV ribonucleic acid [RNA] level [testing not mandatory])
Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n* History of liver disease, such as cirrhosis or chronic active hepatitis B and C\r\n* Presence of hepatitis B surface antigen (HbsAg)\r\n* Presence of hepatitis C antibody test (anti-hepatitis C virus [HCV]) \r\nNote: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and HCV ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Positive serology for hepatitis B virus (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive, the patient will be excluded; consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HB positive
Known hepatitis B antigen (Ag) positive (this includes hepatitis B core Ag and hepatitis B surface Ag positive patients,) hepatitis C antibody positive patients
Active hepatitis b virus (positive hepatitis b surface antigen) or active hepatitis c virus (measurable viral ribonucleic acid [RNA] load with polymerase chain reaction) infection
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
Patients with known positive hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B), positive hepatitis total core antibody with negative HBsAG (suggestive of occult hepatitis B), or detectable hepatitis C virus RNA by a polymerase-chain reaction (PCR) assay (indicative of active hepatitis C – screening is generally done by hepatitis C antibody (HepCAb), followed by hepatitis C virus RNA by PCR if HepCAb is positive)
Patients should be excluded if they have a known history of testing positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV antibody) indicating acute or chronic infection
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies); patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
Liver disease: Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation.
History of human immunodeficiency (HIV) infection or active hepatitis B (chronic or acute) or hepatitis C infection\r\n* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible\r\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Positive test for hepatitis B virus (HBV) surface antigen and/or confirmatory hepatitis C virus (HCV) RNA (if anti-HCV antibody tested positive).
Patients who are known to be hepatitis B surface antigen positive.
Known history of infection with human immunodeficiency virus (HIV) or history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV), or any uncontrolled active systemic infection; hepatitis B surface antigen must be confirmed negative within one year before enrollment; subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Known active hepatitis B or C. HBV and HCV tests are required prior to Day 1.
Known HIV or hepatitis B/C infection (testing not required). Subjects who are hepatitis C antibody positive may be enrolled if they are confirmed to have a negative viral load at screening.
Positive serology for Hepatitis B
Presence of positive test results for Hepatitis B surface antigen (HBsAg); antibody to hepatitis B core antigen [anti-HBc]) with detectable viral load (positive hepatitis B virus [HBV] deoxyribo-nucleic acid [DNA]) or Hepatitis C
Participants with chronic hepatitis B or seropositive occult (HBV) infection
Participants positive for Hepatitis C virus (HCV) antibody were eligible only if polymerase chain reaction(PCR) was negative for HCV Ribonucleic acid (RNA)
Subjects who are seropositive because of hepatitis B virus vaccine
Negative tests for HIV antibodies, Hepatitis B surface antigen, and hepatitis C antibodies.
Active hepatitis B as defined by seropositivity for hepatitis B surface antigen or positive hepatitis B core antibody. Subjects with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases
Hepatitis B or C (HBsAg in the absences or HBsAB or HCV Ab positive with HCV RNA positive)
Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative; if hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by reverse transcriptase (RT)-polymerase chain reaction (PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Chronic active hepatitis B; patients may be hepatitis B core antibody positive; for patients with concomitant positive hepatitis B surface antigen, patient will require a hepatology consultation; the risk/benefit profile of transplant and hepatitis B will be discussed with the patient and eligibility determined by the principal investigator
DONOR: Donors must be human immunodeficiency virus (HIV) negative, hepatitis B surface antigen negative, and hepatitis C antibody negative
Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening
Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors; tests include but are not limited to: hepatitis B surface antigen (HepBsAg), hepatitis B surface antibody (HepBsAb), hepatitis B core antibody (HepBcAb), HepC antibody, human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV) I and II, varicella zoster virus (VZV), cytomegalovirus (CMV) and Venereal Disease Research Laboratory test (VDRL), and West Nile virus; donor must have normal negative test results for HIV, HTLV I and II, and West Nile virus
Active hepatitis B or C (defined as positive hepatitis B surface antigen, hepatitis C antibody)
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Subject has a known history of a positive test for hepatitis B surface antigen or hepatitis C antibody.
A positive Hepatitis B surface antigen or Hepatitis C test result at screening. Historical local data will be acceptable if it the test was done within one month before start of HSCT conditioning and not more than 3 months before study visit 3.
Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
DONOR: Evidence of prior hepatitis B infection as evaluated by hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (anti-HBc immunoglobulin [Ig]M and IgG) and hepatitis B surface antibody (anti-HBsAb); participants demonstrating any one of the following will be excluded:\r\n* positive hepatitis B surface antigen (HBsAg) or \r\n* positive anti-HBc IgM\r\n* positive anti-HBc IgG
DONOR: Positive hepatitis B virus (HBV) PCR
DONOR: Positive anti-hepatitis C (HCV) antibodies and a positive serum HCV RNA PCR; all positive HCV antibody results must be assessed by an enzyme-linked immunosorbent assay (EIA) assay and confirmed by a quantitative serum HCV RNA assay; participants with positive HCV antibodies but undetectable serum HCV ribonucleic acid (RNA) may be considered for eligibility; participants with negative anti-HCV antibodies but unexplained liver enzyme abnormalities must undergo a quantitative serum RNA assay to rule out false negative HCV serologies
Positive serology test for hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis
Patients with active hepatitis B (HBV) (detectable HBV- deoxyribonucleic acid [DNA] or hepatitis B virus surface antigen [HBsAg] +) or hepatitis C (HCV) infection (detectable HCV ribonucleic acid [RNA] by polymerase chain reaction [PCR])
Chronic hepatitis C virus (HCV) infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection
Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
Acute or chronic hepatitis B (HBV) or hepatitis C (HCV) infection requiring concomitant treatment prohibited by this protocol (i.e.immunosuppressive therapy)
Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) ribonucleic acid (RNA) (or HCV antibody)
Positive hepatitis serology:\r\n* Hepatitis B virus (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n* Hepatitis C (hepatitis C virus [HCV]): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb)
Chronic or active hepatitis B or C (patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; patients positive for HCVAb will be eligible if negative for HCV-RNA)
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus antibodies (HCV Ab)
Serologic status reflecting active hepatitis B or C infection; patients that are hepatitis B core antibody positive but antigen negative will need a negative polymerase chain reaction (PCR) prior to enrollment; (hepatitis B antigen or PCR positive patients will be excluded;) (this may not be a necessary exclusion for an ibrutinib monotherapy protocol)
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
All subjects must be screened for hepatitis B and C infection; subjects must either have no history of hepatitis B or C, or must meet the following criteria in order to e eligible:\r\n* Hepatitis B: Subjects infected with hepatitis B must receive anti-hepatitis B therapy; per Infectious Diseases Society of America (IDSA) and American Association for the Study of Liver Diseases (AASLD) guidelines, subjects that show no immunity, defined by the lack of hepatitis B surface antibody, and show evidence of chronic infection (i.e. hepatitis B surface antigen positive [HBsAg+], hepatitis B core antibody positive [HB core AB +], hepatitis B surface antibody negative [HBsAB-]) must be on anti-hepatitis B therapy throughout the study in order to be eligible; the exact hepatitis B therapy is at the discretion of the infection disease specialist or investigator; all patients diagnosed with hepatitis B must also meet the liver function test criteria listed above and have no evidence of cirrhosis; however, all patients who present with acute hepatitis B, or who show normal transaminases but are HBsAg+ and immunoglobulin M positive (IgM+) for hepatitis B core antigen, are ineligible\r\n* Hepatitis C: Subjects, who are hepatitis C antibody positive, with or without a positive hepatitis C ribonucleic acid (RNA) level, must meet the liver function test criteria listed above and have no evidence of cirrhosis; patients diagnosed with hepatitis C less than 6 months before enrollment will be considered to have acute hepatitis C and will be ineligible unless the hepatitis C viral load is undetectable
Known Human Immunodeficiency Virus, or serological evidence for Hepatitis B (positive hepatitis B surface antigen [HBsAg]), or chronic Hepatitis C infection. For subjects who are negative for HBsAg, but Hepatitis B core Antibody [HBcAB] positive, a HBV DNA (viral load) test will be performed and if negative are eligible. Subjects with positive Hepatitis C antibody serology with a negative HCV ribonucleic acid (RNA) test results are eligible.
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Patient has documented evidence of negative tests for the presence of hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)1/2 antibodies within the three months preceding study entry; subjects who do not have such evidence must undergo appropriate testing prior to virus administration; HIV-positive patients are ineligible
Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV) -1, -2 antibody
Hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody positive with elevated liver transaminases; all patients with chronic active hepatitis (including those on antiviral therapy) are ineligible
Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of hepatitis C RNA.
Hepatitis C (HCV) virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B virus surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B virus core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded
Active hepatitis C infection; if positive serology for hepatitis C (HC) defined as a positive test for hepatitis C virus antibody (HCAb), HC quantitative polymerase chain reaction (PCR) will be performed; if PCR is positive the subject will be excluded
SCREENING: Seronegative for active hepatitis B, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
TREATMENT: Seronegative for active hepatitis B, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative
Serology:\r\n* Seronegative for human immunodeficiency virus (HIV) antibody\r\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Positive hepatitis B surface antigen (HBsAg); if HBcAb is positive, Hepatitis B deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) will be evaluated; positive anti hepatitis B core antibody (HBcAb) with an undetectable viral load does not exclude the patient
Positive test for hepatitis B virus surface antigen or hepatitis C virus ribonucleic acid indicating acute or chronic infection
An indeterminate or positive test for antibody to hepatitis C virus (HCV), unless documented to have no detectable viral load on two independent samples.
A positive test for hepatitis B surface antigen (HBsAg).
Positive hepatitis B surface antigen (HBsAg) results
Active hepatitis B or hepatitis C infection; patients with previously resolved hepatitis B infection are eligible; presence of positive test results for hepatitis B infection who have resolved the infection (defined by being positive for hepatitis B [HB] surface antibody [anti-HBs] and polymerase chain reaction [PCR] assay is negative for HB virus [HBV] DNA) are eligible; patients positive for hepatitis C virus (HCV) antibody are eligible only if testing for HCV ribonucleic acid (RNA) is negative
Known positive hepatitis serologies:\r\n* Hepatitis B (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\r\n* Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
Patients are excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV), or hepatitis B or C virus (HBV, HCV). a. Hepatitis B screening is mandatory for all patients (HBsAg and anti-HBc). Patients with active hepatitis B disease should not be treated with obinutuzumab. Patients should be referred to a specialist if they are carriers before treatment starts (see PI or SmPC). Subjects who are positive for anti-HBc and/or anti-HBs but negative for HBsAg and HBV DNA may be treated after consultation with a hepatologist.
For patients with hepatocellular carcinoma secondary to hepatitis B or C, test results should be indicative of chronic viral hepatitis infection:\r\n* Patients with hepatitis B\r\n** Antibodies: Hepatitis B surface antigen (HepBsAg) and hepatitis B core antibody (HepBcAb) should be elevated and hepatitis B surface antibody (HepBsAb) and hepatitis Be antibody (HepBeAb) low, indicating chronic infection; if the pattern is different from this, please notify the PI\r\n** Viral load: COBAS TaqMan test measuring hepatitis B virus (HBV) DNA is reduced in chronic phase hepatitis B; the baseline value as the patient enters this study will be useful to discriminate between drug, disease progression, or increased viral load as possible attributions for worsening symptoms\r\n* Patients with hepatitis C\r\n** Antibodies: Anti-hepatitis C virus (HCV) testing-specific tests used will be based on the site’s standard procedure for identifying hepatitis C\r\n** Viral load: HCV-RNA should be relatively constant in chronic phase of disease, though the level is typically higher than in the acute phase; the baseline value as the patient enters this study will be useful to discriminate between drug, disease progression, or increased viral load as possible attributions for worsening symptoms
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
Positive for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C antibodies
Subjects must meet the protocol-defined criteria for both hepatitis B virus (HBV) and hepatitis C virus (HCV) status
Actively infected with or chronic carriers of hepatitis B virus (HBV) as demonstrated by positive hepatitis B core antibody (HbcAb) or hepatitis B surface antigen (HbsAg). (Patients who are sero-positive only, i.e., surface antibody positive [HbsAb], are permitted).
Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg).
Patient has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, human immunodeficiency virus (HIV)-1, or HIV-2 antibody, or has a history of a positive result.
Patient has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, HIV-1, or HIV-2 antibody, or has a history of a positive result.
Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
Positive serology for hepatitis C based on test at screening.
Hepatitis C virus (HCV) antibody positive
Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B surface antigen (HBsAg) (hepatitis B virus [HBV] surface antigen)
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcriptase (RT)-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg)
Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody will need a negative polymerase chain reaction (PCR) prior to enrollment (PCR positive patients will be excluded); hepatitis C antibody positive patients are eligible if PCR is negative
Presence of positive test results for hepatitis B surface antigen or hepatitis C virus (HCV) antibody
Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation
Participants with occult or prior hepatitis B virus (HBV) infection may be included if HBV deoxyribonucleic acid (DNA) is undetectable at screening. These participants must be willing to undergo monthly HBV DNA test until at least 12 months after the last treatment cycle
Known hepatic cirrhosis, hepatitis B surface antigen-positive status, or suspected active hepatitis C infection. Note: Participants who have isolated positive hepatitis B core antibody (that is, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load.
Known to be positive for hepatitis B by surface antigen expression
Participants demonstrating any one of the following will be excluded:\r\n* Positive hepatitis B surface antigen (HBsAg) or\r\n* Positive anti-HBc IgM\r\n* Positive anti-HBc IgG\r\n* Positive HBV polymerase chain reaction (PCR)
Positive anti-hepatitis C (HCV) antibodies and a positive serum HCV ribonucleic acid (RNA) PCR; all positive HCV antibody results must be assessed by an enzyme immunoassay (EIA) assay and confirmed by a quantitative serum HCV RNA assay; participants with positive HCV antibodies but undetectable serum HCV RNA may be considered for eligibility; participants with negative anti-HCV antibodies but unexplained liver enzyme abnormalities must undergo a quantitative serum RNA assay to rule out false negative HCV serologies
DONOR: Participants demonstrating any one of the following will be excluded:\r\n* Positive hepatitis B surface antigen (HBsAg) or\r\n* Positive anti-HBc IgM\r\n* Positive anti-HBc IgG\r\n* Positive HBV PCR
DONOR: Positive anti-hepatitis C (HCV) antibodies and a positive serum HCV RNA PCR; all positive HCV antibody results must be assessed by an EIA assay and confirmed by a quantitative serum HCV RNA assay; participants with positive HCV antibodies but undetectable serum HCV RNA may be considered for eligibility; participants with negative anti-HCV antibodies but unexplained liver enzyme abnormalities must undergo a quantitative serum RNA assay to rule out false negative HCV serologies
Patients with active hepatitis B, either active carrier (hepatitis B virus surface antigen [HBsAg] +) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV)
Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
Current severe hepatic impairment; Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Hepatitis B or C seropositivity (except for hepatitis B with negative surface antigen and hepatitis B viral load)
Actively infected with or chronic carriers of hepatitis B virus as demonstrated by positive hepatitis B core antibody or hepatitis B surface antigen. (Patients who are seropositive only, i.e. surface antibody positive [HbsAb], are permitted)
Positive hepatitis serology
Seropositive for HIV antibodies (HIV1 and HIV2), Hepatitis C antibody (Hep C Ab) or a Hepatitis B carrier (positive for Hepatitis B surface antigen [HBsAg]).
Patients with known human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active or carriers) are not eligible; this includes all patients with a positive hepatitis C antibody, hepatitis B surface antigen, or hepatitis B core antibody; previously vaccinated patients with positive hepatitis B surface antibody are eligible
Concomitant interferon therapy or therapies for active Hepatitis C virus (HCV) infection
No history of human immunodeficiency virus (HIV), active or chronic hepatitis B, hepatitis C or human T-cell lymphotropic virus (HTLV-I) infection; NOTE: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Positive hepatitis C serology
Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded if unable to tolerate and/or receive anti-hepatitis-B therapy; positive serology because of prior vaccination is allowed
Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb)
A history of known Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection. Subjects with laboratory evidence of cleared HBV and HCV infection may be enrolled.
Acute viral hepatitis or history of chronic or acute HBV, HCV, HAV, HDV, HEV
Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen);
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Seronegative for hepatitis B antigen, or hepatitis C antibody or antigen
Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HBsAg). In addition, if negative for HBsAg but Hepatitis B core antibody (HBcAb) positive, a Hepatitis B Virus (HBV) DNA test will be performed and if positive the subject will be excluded.
Positive blood screen for hepatitis A IgM, hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests; note: hepatitis B surface antigen (HbsAg) and antibody to Hepatitis B core (anti-HBc); hepatitis C antibody; all patients must be screened prior to registration; those patients who have evidence of chronic or acute infection with either hepatitis B or C may not be treated on this protocol
Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HBsAg). In addition, if negative for HBsAg but (Hepatitis B core antibody (HBcAb) positive (regardless of Hepatitis B surface antibody [HBsAb] status), a HB DNA test will be performed and if positive the subject will be excluded. If HBV DNA is negative, subject may be included but must undergo HBV DNA monitoring. Prophylactic antiviral therapy may be initiated at the discretion of the investigator.
Hepatitis B virus deoxyribonucleic acid (DNA) levels >2,000 international units/mL.
Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive human immunodeficiency virus (HIV) test result (enzyme-linked immunosorbent assay [ELISA] and Western blot); hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Presence of hepatitis B surface antigen (HbsAg)
Presence of hepatitis C antibody test (anti-HCV)
Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\r\n* History of liver disease, such as cirrhosis or chronic active hepatitis B and C\r\n* Presence of hepatitis B surface antigen (HBsAg)\r\n* Presence of hepatitis C antibody test (anti-HCV)\r\n* Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
Documented human immunodeficiency virus (HIV), active or chronic hepatitis B, hepatitis C or human T-lymphotropic virus (HTLV)-I infection\r\n* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis C antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion\r\n* Positive hepatitis C serology is an exclusion criterion
Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing
Chronic active hepatitis B; patient may be hepatitis B core antibody positive; for patients with concomitant positive hepatitis B surface antigen, patient will require a hepatology consultation; the risk/benefit profile of transplant and hepatitis B will be discussed with the patient and eligibility determined by the principal investigator and protocol chairperson
DONOR: Donors must be HIV negative, hepatitis B surface antigen negative, and hepatitis C antibody negative; donors with a history of hepatitis B or hepatitis C infection may be eligible; however, eligibility determination of such patients will require a hepatology consultation; the risk/benefit of the transplant and the possibility of transmitting hepatitis will be discussed with the patient and eligibility will then be determined by the principal investigator
Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.
A Hepatitis B/C blood test must be done at screening for all patients; patients who test positive for Hepatitis C antibodies and the Hepatitis B antigen are ineligible
History of infection with the hepatitis B and/or C viruses or positive hepatitis B virus surface antigen and hepatitis C virus antibody
Known positivity for hepatitis B surface antigen (sAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
No history of the following: \r\n* Active known or suspected autoimmune disease\r\n* Human immunodeficiency virus (HIV) with CD4+ count < 300 or detectable viral load; patients with HIV, undetectable viral load, and CD4+ count >= 300 are eligible\r\n* Known active hepatitis B or C\r\n** Hepatitis B can be defined as: \r\n*** Hepatitis B virus surface antigen (HBsAg) > 6 months\r\n*** Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B\r\n*** Persistent or intermittent elevation in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels\r\n*** Liver biopsy showing chronic hepatitis with moderate or severe necroin?ammation\r\n** Hepatitis C can be defined as:\r\n*** Hepatitis C antibody (AB) positive\r\n*** Presence of hepatitis C virus (HCV) RNA\r\n* Known active pulmonary disease with hypoxia defined as oxygen saturation < 85% on room air
History of chronic hepatitis B virus (HBV) infection or positive test results for active or chronic HBV infection defined by hepatitis B surface antigen (HBsAg)
Patients with active or chronic hepatitis C virus (HCV)
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Active hepatitis B, either active carrier (hepatitis B surface antigen [HBsAg] +) or viremic (hepatitis B virus [HBV] DNA >= 10,000 copies/mL, or >= 2,000 IU/mL)
Seronegative for active hepatitis B, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase-polymerase chain reaction (RT-PCR) and be hepatitis C viral load measurement (HCV RNA) negative
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen)
Known hepatitis B (they test positive for the presence of at least one of the following three markers in blood (to be evaluated at screening): hepatitis B surface antigen (HBsAG), antibodies against hepatitis B core antigen (anti-HBc), or hepatitis B viral load (hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or known active hepatitis C infection
Active hepatitis B virus (HBV) defined by positive hepatitis B surface antigen (HBsAg) test at screening; patients with past or resolved HBV infection (defined by a negative HBsAg test and a positive anti-hepatitis B core antigen [anti-HBc] antibody test) are eligible; HBV deoxyribonucleic acid (DNA) must be obtained in these patients prior to first day of study treatment
Active hepatitis C virus (HCV); patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
Subject has a known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV).
Active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible)
Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B surface antigen (HBsAg) (hepatitis B virus [HBV] surface antigen)
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Current or chronic hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV); Note: patients with previous history of hepatitis B (who have cleared the infection and have natural immunity, i.e. hepatitis [Hep] B core antibody positive cases) are excluded if prophylaxis against Hep B reactivation with antiviral agents (such as entecavir) is recommended, after consultation with gastroenterologist/hepatologist or infectious disease team
Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody; if hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative
Known infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); (if a patient was not tested at the time of their leukapheresis, they must be tested prior to receiving T cell infusion; if testing was done for leukapheresis, this is adequate and does not need to be repeated)
Current or chronic hepatitis B or hepatitis C infection (as detected by positive testing for Hepatitis B surface Antigen [Hbs Ag] or antibody to Hepatitis C virus [anti HCV] respectively); patients must be tested for Hepatitis B surface antigen and anti-HCV =< 21 days prior to registration
Patients with risk factors for hepatitis B or C should be tested (anti-hepatitis C virus [HCV] antibody, hepatitis B virus surface protein antigen [HBsAg] or anti-hepatitis B virus core antibody [HBc]); if infection is suspected, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) should be requested as appropriate; Note: Patients with positive Hepatitis B or C serologies without known active disease must meet the eligibility requirements for ALT, AST, total bilirubin, and alkaline phosphatase and must have a normal international normalized ratio (INR) on at least two consecutive occasions, separated by at least 1 week, within the 30 day screening period
Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\r\n* Note: the following will not be exclusionary:\r\n** A positive hepatitis B serology indicative of previous immunization (i.e., HBsAb positive and hepatitis B virus core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection \r\n** Patients with chronic HBV suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in Department of Health and Human Services (DHHS) guidelines\r\n** Positive HCV serology but no detectable HCV RNA, indicative of spontaneously cleared HCV infection\r\n** Patients who have been successfully treated for HCV as long as therapy for HCV has been completed
Any positive test for hepatitis B virus or hepatitis C virus indicating acute infection
Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Subjects who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation.
Active hepatitis C infection as demonstrated by test for hepatitis C RNA. Subjects who are HCV antibody positive will be screened for HCV RNA by any RT PCR or bDNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.
Positive test for hepatitis B virus (HBV) surface antigen
Positive hepatitis C antibody and positive confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) test; the confirmatory HCV RNA test is not required if the HCV antibody is negative; if hepatitis C antibody is positive, the confirmatory HCV RNA test should be done and if it is negative, then participants are eligible
Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening); patients with past/resolved hepatitis B virus (HBV) infection (defined as having negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible; a negative HBA deoxyribonucleic acid (DNA) test must be obtained in patients with positive hepatitis B core antibody prior to cycle 1 day 1
Active hepatitis C infection; patients positive hepatitis C antibody test are eligible if polymerase chain reaction (PCR) is negative for hepatitis C viral DNA
Uncontrolled infection, including active human immunodeficiency virus (HIV)-1, hepatitis B (hepatitis B virus [HBV]) and/or hepatitis C (hepatitis C virus [HCV]) infection (positive HBV or HCV viral load in the setting of positive HBV core antibody or surface antibody or HCV antibody); history of HBV or HCV is allowed if there is no uncontrolled viral infection; patients with any active viral infection are excluded
DONOR: Serologies for human immunodeficiency virus (HIV) antigen (Ag), HIV 1 and HIV 2 antibody (Ab), human T-lymphotropic virus type I (HTLV 1) and HTLV 2 Ab, hepatitis B surface antigen (sAg) or polymerase chain reaction positive (PCR+), or hepatitis C Ab or PCR+, syphilis (Treponema) screen and HIV 1 and hepatitis C by nucleic acid testing (NAT) have been collected prior to apheresis
Documented virology status of hepatitis, as confirmed by screening hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), and/or anti-hepatitis C virus (anti-HCV)
Known history of human immunodeficiency virus (HIV), chronic hepatitis B virus (HBV), or hepatitis C (HCV) requiring treatment; Note: Subjects with serologic evidence of prior vaccination to HBV (i.e., hepatitis B virus surface antigen negative [HBs Ag-], anti-HBs+ and anti-hepatitis B virus core negative[HBc-]) and positive anti-HBc from intravenous immunoglobulin (IVIG) may participate
Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)
Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBV sAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection
Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV); patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; patients who have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C antibody (hepatitis C virus [HCV] Ab)/ribonucleic acid (HCV RNA) indicating acute or chronic infection are also ineligible (baseline testing required)
Has known seropositivity for HIV or hepatitis C antibody, or known to be hepatitis B surface antigen positive (testing for these serologic markers is not required for enrollment in this protocol)
Known active hepatitis B or C; patients must have a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody within 4 weeks prior to starting study drug
Presence of chronic HCV infection; note: chronic HCV infection is defined by (1) presence of plasma or serum HCV RNA in a participant with HCV antibody for >= 180 days, or (2) two documented HCV RNA positive results >= 180 days apart, OR (3) positive HCV RNA with biopsy demonstrating chronic hepatitis
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
RECIPIENT: Seronegative for HIV, HCV and active HBV (surface antigen negative) within 2 months of registration
EXCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT): Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection; subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Patients with active hepatitis B or C determined by polymerase chain reaction (PCR)
Active infection with human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV) (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells); active infection is defined as not being well controlled on therapy (Note: to meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV1 and 2 antibody, negative for hepatitis B surface antigen, or negative for HCV antibody or HCV viral load)
Human immunodeficiency virus (HIV), hepatitis B (hepatitis B core antibody [HBcAb] positive but hepatitis B surface antigen [HBsAg] negative with undetectable viral load are eligible), or hepatitis C infection
Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)
Subjects with positive test for Hepatitis B surface (HBS-Ag) or Hepatitis B core (HBc)antigen
Subjects with positive test for hepatitis C (HCV) infection are excluded regardless of viral load. If hepatitis C antibody test is positive, a confirmatory polymerase chain reaction (PCR) or Recombinant immunoblot assay (RIBA) test should be performed. If the PCR or RIBA test is negative, subject is eligible for this trial
Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C
Active HIV, HBV, HCV or HTLV 1/2 infection (due to increased risk of complications during lymphodepleting regimen and confounding effects on the immune system). Active hepatitis B or C infection is defined by seropositive for hepatitis B surface antigen (HbSAg) or hepatitis C antibody.
Current treatment with anti-viral therapy for Hepatitis B Virus (HBV)
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies); patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
Active or chronic hepatitis B infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening); subject with past or resolved hepatitis B infection (defined as having a negative HBsAg test and positive antibody to hepatitis B core antigen test) are eligible; hepatitis B viral DNA must be obtained in subjects with positive hepatitis B core antibody prior to first treatment start
Active hepatitis C infection; subjects positive hepatitis C antibody test are eligible if polymerase chain reaction (PCR) is negative for hepatitis C viral DNA
Has documented positive results for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody with detectable HCV ribonucleic acid, or hepatitis B surface antigen (HBsAg) within 90 days before randomization
subjects with anti-hepatitis B core antibody but with undetectable HBV DNA and negative for HBsAg
subjects with resolved or treated HCV (i.e. HCV antibody positive but undetectable HCV RNA)
Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
Known history of infection with HIV, hepatitis B (HBsAg positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
History of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV); patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive)
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV antibody) at screening indicating acute or chronic infection
Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e., quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HCV or HBV without documented resolution; testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated
Uncontrolled significant active infections, except Hepatitis B (HBV) or Hepatitis C (HCV)
NOTE: Patients with chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection may enroll if other laboratory criteria are met; those with HBV surface antigen positivity may enroll only if maintained on appropriate suppressive antiviral therapy for the duration of enrollment in the trial
Significant acute or chronic infections as these may affect the immune response including:\r\n* Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\r\n* Positive test for hepatitis B virus (HBV) surface antigen and / or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive)
Known hepatitis B or C virus (HBV or HCV) infection, unless the patient has been cleared for chemotherapy from experts on viral hepatitis (infectious disease specialists or hepatologists)
Tested positive for hepatitis B or C serological markers (hepatitis B surface antigen or antibodies to hepatitis C virus) or human immunodeficiency virus.
Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
Positive test for human immunodeficiency virus (HIV) or hepatitis C (HCV) antibodies (unless HCV viral load test by PCR is negative)
History of any chronic hepatitis including alcoholic, non-alcoholic steatohepatitis (NASH), drug related, autoimmune, chronic viral positive tests for hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (anti-HBc) in the absence of hepatitis B surface antibody (anti-HBs), or a positive hepatitis C (HCV) viral load; these patients are excluded
Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody (unless HCV viral load test by PCR is negative). HBcAb positivity will be allowed if one or more of the following is true: a) HBsAb is present; b) hepatitis B DNA testing is negative and the patient is receiving hepatitis B reactivation prophylaxis with entecavir, tenofovir, or lamivudine
Has active hepatitis B (HBV) or hepatitis C (HCV).