Ibrutinib for the Treatment of Patients With B-Cell Malignancies Who Are Infected With Coronavirus Disease 2019 (COVID-19)
NCT04665115 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-08-03
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
Interventions
- DRUG
-
Given PO
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Academic and Community Cancer Research United
lead OTHER
Principal Investigators
-
Sameer A Parikh · Academic and Community Cancer Research United
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-23
- Primary Completion
- 2021-11-19
- Completion
- 2022-07-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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