[c09aa8]: / clusters / final9knumclusters / clust_2088.txt

Download this file

56 lines (55 with data), 22.8 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
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