Status:
WITHDRAWN
Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
Academic and Community Cancer Research United
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Asymptomatic COVID-19 Infection Laboratory-Confirmed
B-Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the effects of ibrutinib in treating patients with B-cell malignancies who are infected with COVID-19. Ibrutinib may stop the growth of tumor cells by blocking some of the ...
Detailed Description
PRIMARY OBJECTIVES: I. To characterize and describe the patterns of temporary interruption vs. continuation of ibrutinib after their coronavirus disease 2019 (COVID-19) diagnosis and their correspond...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04665115
Start Date
November 23 2020
End Date
July 22 2022
Last Update
August 3 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905