Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19)

NCT04665115 | Withdrawn Phase 2 FDA Drug

• 3 other identifiers: ACCRU-LY-2001NCI-2020-11785P30CA015083
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Asymptomatic COVID-19 Infection Laboratory-Confirmed; B-Cell Neoplasm; Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Small Lymphocytic Lymphoma; Symptomatic COVID-19 Infection Laboratory-Confirmed; Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who require hospitalization for their COVID-19 disease or die (Cohort 1)

  Will calculate the proportion of patients who were outpatient at the time of study entry, and evaluate whether or not patients in this cohort required hospitalization associated with their coronavirus disease 2019 (COVID-19) infection.

  Up to 28 days after study registration

• Proportion of patients who require mechanical ventilation and/or die (Cohort 2)

  Up to 28 days after study entry

Secondary Outcomes (13)

• Rate of "flare phenomena" (Cohort I)

  Up to 84 days

• Patient-reported health and symptom status (Cohort I)

  Up to 84 days

• Patterns on ibrutinib therapy during COVID-19 infection (Cohort I)

  Up to 84 days

• Reasons for hospitalization (Cohort I)

  Up to 84 days

• Mortality (Cohort II)

  Up to 84 days

Study Arms (3)

Cohort I (ibrutinib)

EXPERIMENTAL

Patients may continue to receive ibrutinib PO daily or stop ibrutinib per provider's discretion.

Drug: Ibrutinib; Other: Quality-of-Life Assessment

Cohort II Arm 2A (ibrutinib)

EXPERIMENTAL

Patients continue to receive ibrutinib PO daily in the absence of disease progression or unacceptable toxicity.

Drug: Ibrutinib; Other: Quality-of-Life Assessment

Cohort II Arm 2B (temporary interruption)

EXPERIMENTAL

Patients undergo temporary interruption of ibrutinib for up to 28 days unless they are discharged home and are thought to be medically fit by the primary caregiver to resume therapy according to their primary treating oncologist.

Other: Quality-of-Life Assessment

Interventions

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

Cohort I (ibrutinib); Cohort II Arm 2A (ibrutinib)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Cohort I (ibrutinib); Cohort II Arm 2A (ibrutinib); Cohort II Arm 2B (temporary interruption)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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
• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Academic and Community Cancer Research United: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Sameer A Parikh

  Academic and Community Cancer Research United

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 11, 2020
• Study Start: November 23, 2020
• Primary Completion: November 19, 2021
• Study Completion: July 22, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

US (1)