Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma
NCT04402138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-05-13
Summary
This is a phase II study to evaluate efficacy of Acalabrutinib as a maintenance therapy following blood or marrow transplant (BMT) in patients who have been diagnosed with mantle cell lymphoma.
Conditions
Interventions
- DRUG
-
Acalabrutinib 129 mg will be self-administered orally twice daily (BID) starting from 100 day (+/- 7 days) Post-BMT on a 28-day schedule, with or without food, until the patient has reached approximately 2 years post-BMT.
Sponsors & Collaborators
-
Acerta Pharma, LLC
collaborator OTHER -
SCRI Development Innovations, LLC
lead OTHER
Principal Investigators
-
Michael Tees, MD · Colorado Blood Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-07
- Primary Completion
- 2024-04-05
- Completion
- 2024-04-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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