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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT04665115
Phase
PHASE2
Status
Withdrawn

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Nov 23, 2020
Status verified
Aug 2022
Primary completion
Nov 19, 2021
Completion
Jul 22, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (ibrutinib)
    Patients may continue to receive ibrutinib PO daily or stop ibrutinib per provider's discretion.
  • Experimental: Cohort II Arm 2A (ibrutinib)
    Patients continue to receive ibrutinib PO daily in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort II Arm 2B (temporary interruption)
    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.

Primary Outcome Measure

Proportion of patients who require hospitalization for their COVID-19 disease or die (Cohort 1) [ Time Frame: Up to 28 days after study registration ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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