Abexinostat and Ibrutinib in Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma
NCT03939182 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-04-25
Summary
The purpose of this study is to test the safety of abexinostat at different doses to find out if it can work with ibrutinib to stop the cancer from growing.
Conditions
- Diffuse Large B-cell Lymphoma
- Mantle Cell Lymphoma
Interventions
- DRUG
-
Abexinostat
Two doses of the abexinostat will be tested: 30 mg/m2 and 45 mg/m2 orally twice daily, 7 days/week given every other week during a 28-day cycle.
- DRUG
-
Ibrutinib will be given at the FDA-approved dose for mantle cell lymphoma (MCL) of 560 mg orally daily for 28 day cycle.
Sponsors & Collaborators
-
Janssen Scientific Affairs, LLC
collaborator INDUSTRY -
Xynomic Pharmaceuticals, Inc.
collaborator INDUSTRY -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Gilles Salles, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-29
- Primary Completion
- 2025-04-22
- Completion
- 2025-04-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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