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| # | Blank 1 | Frequency | Blank 2 | Frequency | |
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| 1 | 3 | active human immunodeficiency virus hiv or hepatitis c virus hcv or hepatitis b virus hbv subjects who have an undetectable hiv | 3 | 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 resmcLt 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 | 3 |
| 2 | 2 | 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 | 2 | dna | 3 |
| 3 | 4 | 2 | 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 | 2 | |
| 4 | 21 | active hepatitis c infection subjects positive hepatitis c antibody test are eligible if polymerase chain reaction pcr is negative for hepatitis c | 2 | 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 | 1 |
| 5 | 23 | subjects with serologic status reflecting active | 2 | 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 immunoglobmcLin 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 | 1 |
| 6 | 1 | presence of fungal bacterial | 1 | fungal mycobacterial parasitic | 1 |
| 7 | 5 | 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 | 1 | or other hepatitis | 1 |
| 8 | 7 | 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 | 1 | load must be undetectable per quantitative polymerase chain reaction pcr and / or nucleic acid testing . | 1 |
| 9 | 8 | 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 resmcLt before enrollment those who are pcr positive will be excluded subjects who have an undetectable human immunodeficiency virus hiv | 1 | 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 shomcLd be used with caution in patients treated with nivolumab containing regimen | 1 |
| 10 | 10 | 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 resmcLt before enrollment those who are pcr positive will be excluded subjects who have an undetectable human immunodeficiency virus hiv | 1 | load with cd4 > = 200 and are on highly active antiretroviral therapy haart medication are allowed | 1 |
| 11 | 11 | 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 | 1 | hbv deoxyribonucleic acid dna or hcv ribonucleic acid rna resmcLt prior to enrollment those who are hbsag positive or hbv dna positive and those who are positive for hcv rna will be excluded | 1 |
| 12 | 13 | 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 | 1 | 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 immunoglobmcLin 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 | 1 |
| 13 | 14 | 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 | 1 | 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 | 1 |
| 14 | 15 | 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 | 1 | 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 immunoglobmcLin 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 | 1 |
| 15 | 16 | patients who have any severe and / or uncontrolled medical conditions or other conditions that comcLd 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 mcLn note optimal glycemic control shomcLd 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 | 1 | load and serologic markers hbv dna hepatitis b virus surface antigen hbsag | 1 |
| 16 | 17 | 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 | 1 | 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 | 1 |
| 17 | 18 | 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 | 1 | load note subjects with a positive hepatitis c antibody and negative quantitative hepatitis c polymerase chain reaction pcr viral load are eligible | 1 |
| 18 | 19 | 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 | 1 | 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 shomcLd 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 | 1 |
| 19 | 22 | 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 | 1 | 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 | 1 |
| 20 | 25 | subjects who have current active hepatic hepatitis b virus surface antigen hbsag hepatitis b virus core antibody hbcab and positive | 1 | 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 | 1 |
| 21 | 26 | 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 | 1 | 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 | 1 |
| 22 | 27 | active hepatitis c infection patients positive hepatitis c antibody test are eligible if polymerase chain reaction pcr is negative for hepatitis c | 1 | load by polymerase chain reaction pcr or biliary disease with exception of patients with gilbert s syndrome asymptomatic gallstones | 1 |
| 23 | 28 | subjects with positive test for hepatitis c hcv infection are excluded regardless of | 1 | load does not exclude the patient | 1 |
| 24 | 30 | rapid influenza diagnostic test ridt polymerase chain reaction pcr or | 1 | load . if hepatitis c antibody test is positive a confirmatory polymerase chain reaction pcr or recombinant immunoblot assay riba test shomcLd be performed . if the pcr or riba test is negative subject is eligible for this trial | 1 |
| 25 | 31 | active hepatitis b virus positive hepatitis b surface antigen or active hepatitis c virus measurable | 1 | cmcLture positive for influenza | 1 |
| 26 | 32 | must have herv k hml2 | 1 | ribonucleic acid rna load with polymerase chain reaction infection | 1 |
| 27 | 33 | 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 | 1 | load of > = 1 x 10 4 using a gag primer reverse transcriptase rt polymerase chain reaction pcr assay | 1 |
| 28 | 34 | patients with active hepatitis b or c | 1 | 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 | 1 |
| 29 | 6 | NA | replication by polymerase chain reaction pcr | 1 |