Clinical trial · Interventional
Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19)
A Prospective Study of Patients With B-Cell Hematologic Malignancies on Ibrutinib Therapy Who Are Infected With Coronavirus Disease 2019 (COVID-19)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Permanently closed 11/19/201. The widespread availability of COVID vaccination, the projected decline in infection rates, and the increasing use of non-ibrutinib containing BTKi therapy, we have not been able to get support for this study
Summary
Brief summary (as posted)
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 enzymes needed for cell growth. Ibrutinib is a first in class Bruton tyrosine kinase inhibitor (BTKi), for the treatment of B-cell malignancies. This study is being done to determine if taking ibrutinib after contracting COVID-19 will make symptoms better or worse.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asymptomatic COVID-19 Infection Laboratory-Confirmed | — | UNRESOLVED | — |
| B-Cell Neoplasm | B-Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort I (ibrutinib)
- description
- Patients may continue to receive ibrutinib PO daily or stop ibrutinib per provider's discretion.
- interventionNames
- Drug: Ibrutinib
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Cohort II Arm 2A (ibrutinib)
- description
- Patients continue to receive ibrutinib PO daily in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Ibrutinib
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Cohort II Arm 2B (temporary interruption)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) Exclusion Criteria: * 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
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