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

inclusion criteria: - registration inclusion - (cohort 1): age >= 18 years - cohort 1: laboratory confirmed diagnosis of covid-19 through confirmation of sars-co-v2 via reverse transcriptase polymerase chain reaction (rt-pcr) or any food and drug administration (fda) approved method. the date of test result is required to be =< 7 days prior to registration (note: please use the date the test was resulted and not the date when the test was collected) - cohort 1: patient is on ibrutinib for the following approved fda indications, including: - chronic lymphocytic leukemia/small lymphocytic lymphoma - mantle cell lymphoma - waldenstrom macroglobulinemia - marginal zone lymphoma - cohort 1: patients have been on standard dose ibrutinib therapy (420 mg daily for chronic lymphocytic leukemia [cll]/small lymphocytic lymphoma [sll] and waldenstrom/waldenstrom macroglobulinemia, and 560 mg daily for mantle cell lymphoma and marginal zone lymphoma) for at least 6 months prior to diagnosis of covid-19 infection; and there is no evidence of disease progression of the primary malignancy for which ibrutinib is being used - note: patients are allowed to receive standard treatment as per local institutional guidelines for the treatment of covid-19 at the same time the patient is enrolled on this trial - cohort 1: provide informed written consent =< 7 days prior to registration - cohort 1: willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) - note: during the active monitoring phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up. all of these visits will be virtual (phone or video) only - cohort 1: willing to provide blood specimens for correlative research purposes - randomization inclusion - cohort 2: age >= 18 years - cohort 2: laboratory confirmed diagnosis of covid-19 through confirmation of sars-co-v2 via rt-pcr or any fda approved method. the date of test result is required to be =< 7 days prior to registration (note: please use the date the test was resulted and not the date when the test was collected) - cohort 2: patient is on ibrutinib for the following approved fda indications, including: - chronic lymphocytic leukemia/small lymphocytic lymphoma - mantle cell lymphoma - waldenstrom macroglobulinemia - marginal zone lymphoma - cohort 2: patients have been on standard dose ibrutinib therapy (420 mg daily for cll/sll and waldenstrom macroglobulinemia, and 560 mg daily for mantle cell lymphoma and marginal zone lymphoma) for at least 6 months prior to diagnosis of covid-19 infection; and there is no evidence of disease progression of the primary malignancy for which ibrutinib is being used - note: patients are allowed to receive standard treatment as per local institutional guidelines for the treatment of covid-19 at the same time the patient is enrolled on this trial - cohort 2: provide informed written consent =< 7 days prior to registration - cohort 2: willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) - note: during the active monitoring phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up. all of these visits will be virtual (phone or video) only - cohort 2: willing to provide blood specimens for correlative research purposes - cohort 2: absolute neutrophil count (anc) > 750 cells/mm^3 (0.75 x 10^9/l) - cohort 2: platelet count > 50,000 cells/mm^3 (50 x 10^9/l) - cohort 2: estimated creatinine clearance (crcl) >= 30 ml/min (cockcroft-gault) - cohort 2: bilirubin =< 2.0 x upper limit of normal (uln) (unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin) - cohort 2: aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 5 x uln - cohort 2: prothrombin time (pt)/international normal ratio (inr) < 1.5 x (upper limit of normal) uln and partial thromboplastin time (ptt) (activated partial thromboplastin time [aptt]) < 1.5 x uln (unless abnormalities are unrelated to coagulopathy or bleeding disorder)

inclusion criteria: - registration inclusion - (cohort 1): age >= 18 years - cohort 1: laboratory confirmed diagnosis of covid-19 through confirmation of sars-co-v2 via reverse transcriptase polymerase chain reaction (rt-pcr) or any food and drug administration (fda) approved method. the date of test result is required to be =< 7 days prior to registration (note: please use the date the test was resulted and not the date when the test was collected) - cohort 1: patient is on ibrutinib for the following approved fda indications, including: - chronic lymphocytic leukemia/small lymphocytic lymphoma - mantle cell lymphoma - waldenstrom macroglobulinemia - marginal zone lymphoma - cohort 1: patients have been on standard dose ibrutinib therapy (420 mg daily for chronic lymphocytic leukemia [cll]/small lymphocytic lymphoma [sll] and waldenstrom/waldenstrom macroglobulinemia, and 560 mg daily for mantle cell lymphoma and marginal zone lymphoma) for at least 6 months prior to diagnosis of covid-19 infection; and there is no evidence of disease progression of the primary malignancy for which ibrutinib is being used - note: patients are allowed to receive standard treatment as per local institutional guidelines for the treatment of covid-19 at the same time the patient is enrolled on this trial - cohort 1: provide informed written consent =< 7 days prior to registration - cohort 1: willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) - note: during the active monitoring phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up. all of these visits will be virtual (phone or video) only - cohort 1: willing to provide blood specimens for correlative research purposes - randomization inclusion - cohort 2: age >= 18 years - cohort 2: laboratory confirmed diagnosis of covid-19 through confirmation of sars-co-v2 via rt-pcr or any fda approved method. the date of test result is required to be =< 7 days prior to registration (note: please use the date the test was resulted and not the date when the test was collected) - cohort 2: patient is on ibrutinib for the following approved fda indications, including: - chronic lymphocytic leukemia/small lymphocytic lymphoma - mantle cell lymphoma - waldenstrom macroglobulinemia - marginal zone lymphoma - cohort 2: patients have been on standard dose ibrutinib therapy (420 mg daily for cll/sll and waldenstrom macroglobulinemia, and 560 mg daily for mantle cell lymphoma and marginal zone lymphoma) for at least 6 months prior to diagnosis of covid-19 infection; and there is no evidence of disease progression of the primary malignancy for which ibrutinib is being used - note: patients are allowed to receive standard treatment as per local institutional guidelines for the treatment of covid-19 at the same time the patient is enrolled on this trial - cohort 2: provide informed written consent =< 7 days prior to registration - cohort 2: willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) - note: during the active monitoring phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up. all of these visits will be virtual (phone or video) only - cohort 2: willing to provide blood specimens for correlative research purposes - cohort 2: absolute neutrophil count (anc) > 750 cells/mm^3 (0.75 x 10^9/l) - cohort 2: platelet count > 50,000 cells/mm^3 (50 x 10^9/l) - cohort 2: estimated creatinine clearance (crcl) >= 30 ml/min (cockcroft-gault) - cohort 2: bilirubin =< 2.0 x upper limit of normal (uln) (unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin) - cohort 2: aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 5 x uln - cohort 2: prothrombin time (pt)/international normal ratio (inr) < 1.5 x (upper limit of normal) uln and partial thromboplastin time (ptt) (activated partial thromboplastin time [aptt]) < 1.5 x uln (unless abnormalities are unrelated to coagulopathy or bleeding disorder)