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
History of hepatitis B (HBV) with surface antigen (HBsAg) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months, it must be done at screening);
No known positivity of hepatitis B surface antigen (HBsAg), or of positive hepatitis C antibody
Negative hepatitis B surface antigen (HBsAg) test at screening
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
Known hepatitis B surface antigen (HBsAg) positive.
Active infection including hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
HBV surface antigen (HBsAg) positive
Presence of positive test results for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HcAb) (for participants receiving regimen including rituximab)
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).
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
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.
Has untreated active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive)
Hepatitis B surface antigen (HBsAG) positive or hepatitis B core antibody positive
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
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
Known positive for HIV, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
Patients with evidence of chronic active Hepatitis B (positive for HbsAg) and Hepatitis C (positive for viral RNA).
Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive).
Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening
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
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)
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)
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)
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.
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)
Participants who are Hepatitis B surface antigen positive (HBsAg+) (must be PCR negative) who are taking antivirals, are allowed to enroll.
Any positive test for hepatitis C virus (HCV) RNA or hepatitis B surface antigen (HBsAg)
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;
Positive serological test results for hepatitis B
Positive serological test result for hepatitis C
Positive serology for HBV defined as a positive test for HBsAg; in addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HepB DNA test will be performed and if positive the subject will be excluded
Presence of an active acute or chronic infection including: a urinary tract infection as determined by their physician, HIV (as determined by enzyme-linked immunosorbent assay [ELISA] and confirmed by Western blot) or viral hepatitis (as determined by hepatitis B surface antigen [HBsAg] and hepatitis C serology)
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
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).
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 test result for hepatitis B surface antigen (HBsAG), hepatitis B core antibody (HBcAb), or confirmed positive anti-HIV antibody test
Patients with active Hepatitis B infection (HBsAg positive) that are not receiving antiviral treatment are excluded
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.
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.
REGISTRATION TO TREATMENT (STEP 1): Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)
REGISTRATION TO TREATMENT (STEP 2): Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)
Positive for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) and known history of HIV, malignancy, active infection and cardiovascular diseases (CVs)
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
Presence of hepatitis B surface antigen (HbsAg)
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
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)
Known history of HIV or AIDS; or positive test for hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg)
HBsAg positive
Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
Hepatitis B surface antigen (HBsAg) positive
Hepatitis B surface Antigen (HBsAg) positive
Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) or Human Immunodeficiency Virus (HIV)
Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)
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 infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
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:
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
Patient is hepatitis C virus (HCV) antibody (Ab) positive or hepatitis B surface antigen (HBSAg) positive
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
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
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)
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
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)
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
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
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
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
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
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.
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
Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
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.
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
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
A positive test for hepatitis B surface antigen (HBsAg).
Positive hepatitis B surface antigen (HBsAg) results
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).
HBsAG positive
Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg)
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)
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
Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
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 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 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.
Presence of hepatitis B surface antigen (HbsAg)
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.
Active uncontrolled infection, including Hepatitis B, Hepatitis C infection. Patients with anti-HBc positive, or HBsAg but DNA negative are exception(s)
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
Subject has a known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV).
Positive test for hepatitis B virus (HBV) surface antigen
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)
Subjects with positive test for Hepatitis B surface (HBS-Ag) or Hepatitis B core (HBc)antigen
Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy). HBcAb positivity will be allowed if HBsAb is present.