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
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
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 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
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)
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).
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 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
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)
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).
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.
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
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
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)
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)
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)
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
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)
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)
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)
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
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
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.
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
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 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
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
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
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)
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
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)
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)
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 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 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)
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)
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
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).
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
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 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 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)
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
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
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).
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)
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
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
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
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
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
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
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.
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
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
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)
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
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 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
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 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
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
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 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 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
DONOR: Positive hepatitis B virus (HBV) PCR
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])
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
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.
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
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
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
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
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
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 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
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
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
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)
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
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)
Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR)
Patients seropositive or PCR positive for the human immunodeficiency virus (HIV). Patients with evidence of Hepatitis B or Hepatitis C PCR positivity
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
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)
Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR)
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 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
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
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)
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.)
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
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
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.
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
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
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
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
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
Active hepatitis C infection; subjects positive hepatitis C antibody test are eligible if polymerase chain reaction (PCR) is negative for hepatitis C viral DNA
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
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.
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
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
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)
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.
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
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)
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 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
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)
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 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
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)
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)
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
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)
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
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.
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 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)
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.
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)
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
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
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 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)
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)
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
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
Active hepatitis C infection; patients positive hepatitis C antibody test are eligible if polymerase chain reaction (PCR) is negative for hepatitis C viral DNA
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)
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
Active hepatitis C infection; subjects positive hepatitis C antibody test are eligible if polymerase chain reaction (PCR) is negative for hepatitis C viral DNA
Positive serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection
Microsatellite stable disease determined by IHC and/or polymerase chain reaction (PCR).
Serologic status and/or polymerase chain reaction (PCR) testing reflecting active hepatitis B or C infection
Documented human immunodeficiency virus (HIV) infection or positive serology, active bacterial infections, serologic or polymerase chain reaction (PCR) evidence for active or chronic hepatitis B or hepatitis C
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.
EGFRvIII, the target antigen, must be identified on tumor tissue by immunohistochemistry (IHC) or polymerase chain reaction (PCR), i.e. EGFRvIII positive via pathology report
Positive test for hepatitis C antibody (patients with documented clearance of hepatitis C by polymerase chain reaction [PCR] following treatment will be permitted)
Active hepatitis B infection as documented by positive hepatitis B polymerase chain reaction (PCR) assay
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
Active hepatitis C, defined by the detection of hepatitis C ribonucleic acid (RNA) in plasma by polymerase chain reaction (PCR)
Positive study for Hepatitis B surface antigen or Hepatitis B or C confirmed by polymerase chain reaction (PCR)
Known to be positive for hepatitis B by surface antigen expression; known to have active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months)
Documentation of HPV tested by polymerase chain reaction (PCR)
Active hepatitis C, defined by the detectable hepatitis C ribonucleic acid (RNA) in plasma by polymerase chain reaction (PCR)
Expression of one (1) or more of the following TAPAs: SP17, AKAP4, Ropporin, PTTG1 and Span-xb, by either reverse transcriptase polymerase chain reaction (RT-PCR) and/or immunocytochemistry, Western blotting or ELISA, in neoplastic cells and/or blood.
The presence of the target antigen, EGFRvIII, must be identified on tumor tissue by immunohistochemistry (IHC) or polymerase chain reaction (PCR)
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)
Detectable circulating tumor cells (CTCs) with detectable AR?V7 splice?variant by reverse transcriptase (RT)?polymerase chain reaction (PCR)
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 known human immunodeficiency virus (HIV) infection
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
Known to be positive for hepatitis B by surface antigen expression; known to have active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months)
Active hepatitis B or hepatitis C (virus detectable by polymerase chain reaction [PCR])
Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza
A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test
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).
Known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (by polymerase chain reaction [PCR])
Diagnosis of advanced stage or metastatic HER2-positive cancer (immunohistochemistry or reverse transcriptase-polymerase chain reaction [RT-PCR] is used to determine HER2 positivity)
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.
Known to have active hepatitis C infection (positive by polymerase chain reaction) or on antiviral therapy for hepatitis C within 6 months prior to the first doses of brentuximab vedotin and lenalidomide
Patients known to be positive for hepatitis B by surface antigen expression; known to have active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months)
MART-1 positive melanoma by reverse transcription (RT)-polymerase chain reaction (PCR) or immunohistochemistry (IHC)
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
Participants must demonstrate evidence of persistent disease either by cytogenetics/FISH or by polymerase chain reaction (PCR) for BCR/ABL in the peripheral blood or bone marrow
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
Active hepatitis B infection as documented by positive hepatitis B polymerase chain reaction (PCR) assay
Known to be positive for hepatitis B by surface antigen expression; known to have active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months); known to be active cytomegalovirus (CMV) infection or herpes zoster infection
Known to have active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months)
Must have HERV-K(HML2) viral load of >= 1 x 10^4 using a gag primer reverse transcriptase (RT)-polymerase chain reaction (PCR) assay
Subjects meeting the following criteria will be excluded from enrollment in the pre-phase arm of the study, but may be included in the GA only arm\r\n* Contraindication to use rituximab or prednisone including:\r\n** Uncontrolled diabetes mellitus\r\n** Systemic fungal infection\r\n** Evidence of active hepatitis B infection (i.e. patients testing positive for hepatitis B surface antigen or viral deoxyribonucleic acid [DNA] by polymerase chain reaction [PCR] analysis) will be excluded; patients with evidence of past infection without active viremia (i.e. positive hepatitis B DNA PCR) will be treated with entecavir as per institutional guidelines and may be included in the study\r\n** History of any serious adverse reaction to either a corticosteroid or rituximab not including rituximab infusion reactions =< grade 3
Patients with active Hepatitis B or C viral replication by polymerase chain reaction (PCR)
Patients with active hepatitis B or C determined by polymerase chain reaction (PCR)
Serologic status and/or polymerase chain reaction (PCR) testing reflecting active hepatitis B or C infection
Tumor O(6)-methylguanine-DNA-methyltransferase (MGMT) methylation status must be available; results of routinely used methods for MGMT methylation testing (e.g. mutagenically separated polymerase chain reaction, MSPCR, or quantitative polymerase chain reaction [PCR]) are acceptable
Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available; results of routinely used methods for MGMT methylation testing (e.g. mutagenically separated polymerase chain reaction [MSPCR] or quantitative polymerase chain reaction [PCR]) are acceptable
Part 2 patients must have tumor MGMT methylation status of unmethylated; results of routinely used methods for MGMT methylation testing (e.g. mutagenically separated polymerase chain reaction [MSPCR] or quantitative polymerase chain reaction [PCR]) are acceptable
Patients must have tumor MGMT methylation status of unmethylated as determined by local pathologist using a Clinical Laboratory Improvement Act (CLIA)-approved diagnostic test; results of routinely-used methods for MGMT methylation testing (e.g. methylation-specific [MS]- polymerase chain reaction [PCR] or quantitative PCR) are acceptable
Tumor MGMT methylation status must be available; results of routinely used methods for MGMT methylation testing (e.g. methylation-specific polymerase chain reaction [MSPCR ] or quantitative polymerase chain reaction [PCR]) are acceptable
Sufficient tissue available for central pathology review and MGMT methylation status evaluation
Must have known MGMT methylation and IDH1 mutation status to be screened for study entry.
Determination of MGMT promoter status by methylation-specific polymerase chain reaction (PCR) per local institutional guidelines is required to assess eligibility for this Arm.