Created at Source Raw Value Validated value
Dec. 13, 2020, 12:31 a.m. usa

- registration exclusion - cohort 1: patient is receiving ibrutinib therapy for chronic graft-versus-host disease (cgvhd) - cohort 1: patient is currently receiving (or has in the past 6 months) another treatment in combination with ibrutinib, such as anti-cd20 monoclonal antibody, bcl-2 antagonists such as venetoclax, or other novel treatments or chemotherapeutic agents. for clarification regarding specific medications not listed here, please discuss with the principal investigator - cohort 1: 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 - cohort 1: concomitant use of a strong cyp3a inhibitor - cohort 1: vaccinated with a live, attenuated vaccine within 4 weeks - cohort 1: patients with chronic liver disease and hepatic impairment meeting child pugh class c - cohort 1: history of stroke or intracranial hemorrhage within 6 months before registration - cohort 1: history of bleeding diathesis (e.g. hemophilia, von willebrand/waldenstrom disease) - cohort 1: clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the new york heart association functional classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration - cohort 1: chemotherapy for other malignancies - cohort 1: concurrent systemic immunosuppressant therapy within 21 days of the first dose of study drug with the exception of that which is part of the standard of care for covid-19 - cohort 1: major surgery within 4 weeks of registration - cohort 1: female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 1 month of last dose of study drug. male subjects who plan to father a child while enrolled in this study or within 3 months after the last dose of study drug - randomization exclusion - cohort 2: patient is receiving ibrutinib on a clinical trial for their underlying b-cell malignancy - cohort 2: patient is receiving ibrutinib therapy for chronic graft-versus-host disease (cgvhd) - cohort 2: patient is currently receiving (or has in the past 6 months) another treatment in combination with ibrutinib, such as anti-cd20 monoclonal antibody, bcl-2 antagonists such as venetoclax, or other novel treatments or chemotherapeutic agents. for clarification regarding specific medications not listed here, please discuss with the principal investigator - cohort 2: 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 - cohort 2: concomitant use of a strong cyp3a inhibitor - cohort 2: vaccinated with a live, attenuated vaccine within 4 weeks of registration - cohort 2: patients with chronic liver disease and hepatic impairment meeting child pugh class b and c - cohort 2: history of stroke or intracranial hemorrhage within 6 months before registration - cohort 2: history of bleeding diathesis (e.g. hemophilia, von willebrand disease) - cohort 2: clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the new york heart association functional classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration - cohort 2: chemotherapy for other malignancies - cohort 2: concurrent systemic immunosuppressant therapy =< 21 days of the first dose of study drug with the exception of that which is part of the standard of care for covid-19 - cohort 2: major surgery within 4 weeks of registration - cohort 2: female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 1 month of last dose of study drug. male subjects who plan to father a child while enrolled in this study or within 3 months after the last dose of study drug - cohort 2: patients stopped ibrutinib >= 7 days prior to registration, for any reason - cohort 2: patient is an active participant on investigational therapy through an institutional review board (irb) approved clinical trial for covid-19 (note: participation through compassionate use protocol or expanded access is permitted) - cohort 2: at time of registration, the patient requires: - endotracheal intubation and mechanical ventilation

- registration exclusion - cohort 1: patient is receiving ibrutinib therapy for chronic graft-versus-host disease (cgvhd) - cohort 1: patient is currently receiving (or has in the past 6 months) another treatment in combination with ibrutinib, such as anti-cd20 monoclonal antibody, bcl-2 antagonists such as venetoclax, or other novel treatments or chemotherapeutic agents. for clarification regarding specific medications not listed here, please discuss with the principal investigator - cohort 1: 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 - cohort 1: concomitant use of a strong cyp3a inhibitor - cohort 1: vaccinated with a live, attenuated vaccine within 4 weeks - cohort 1: patients with chronic liver disease and hepatic impairment meeting child pugh class c - cohort 1: history of stroke or intracranial hemorrhage within 6 months before registration - cohort 1: history of bleeding diathesis (e.g. hemophilia, von willebrand/waldenstrom disease) - cohort 1: clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the new york heart association functional classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration - cohort 1: chemotherapy for other malignancies - cohort 1: concurrent systemic immunosuppressant therapy within 21 days of the first dose of study drug with the exception of that which is part of the standard of care for covid-19 - cohort 1: major surgery within 4 weeks of registration - cohort 1: female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 1 month of last dose of study drug. male subjects who plan to father a child while enrolled in this study or within 3 months after the last dose of study drug - randomization exclusion - cohort 2: patient is receiving ibrutinib on a clinical trial for their underlying b-cell malignancy - cohort 2: patient is receiving ibrutinib therapy for chronic graft-versus-host disease (cgvhd) - cohort 2: patient is currently receiving (or has in the past 6 months) another treatment in combination with ibrutinib, such as anti-cd20 monoclonal antibody, bcl-2 antagonists such as venetoclax, or other novel treatments or chemotherapeutic agents. for clarification regarding specific medications not listed here, please discuss with the principal investigator - cohort 2: 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 - cohort 2: concomitant use of a strong cyp3a inhibitor - cohort 2: vaccinated with a live, attenuated vaccine within 4 weeks of registration - cohort 2: patients with chronic liver disease and hepatic impairment meeting child pugh class b and c - cohort 2: history of stroke or intracranial hemorrhage within 6 months before registration - cohort 2: history of bleeding diathesis (e.g. hemophilia, von willebrand disease) - cohort 2: clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the new york heart association functional classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration - cohort 2: chemotherapy for other malignancies - cohort 2: concurrent systemic immunosuppressant therapy =< 21 days of the first dose of study drug with the exception of that which is part of the standard of care for covid-19 - cohort 2: major surgery within 4 weeks of registration - cohort 2: female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 1 month of last dose of study drug. male subjects who plan to father a child while enrolled in this study or within 3 months after the last dose of study drug - cohort 2: patients stopped ibrutinib >= 7 days prior to registration, for any reason - cohort 2: patient is an active participant on investigational therapy through an institutional review board (irb) approved clinical trial for covid-19 (note: participation through compassionate use protocol or expanded access is permitted) - cohort 2: at time of registration, the patient requires: - endotracheal intubation and mechanical ventilation