A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R or R-CHOP for Patients With Richter's Syndrome
NCT03054896 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2025-08-14
Summary
This research study is evaluating the combination of a study drug, venetoclax, and a standard chemotherapy regimen, R-EPOCH or R-CHOP, as a possible treatment for Richter's Syndrome.
The drugs involved in this study are:
* Venetoclax
* R-EPOCH:
* Rituximab
* Etoposide
* Prednisone
* Vincristine Sulfate (Oncovin)
* Cyclophosphamide
* Doxorubicin Hydrochloride (Hydroxydaunomycin)
* R-CHOP:
* Rituximab
* Cyclophosphamide Vincristine
* Doxorubicin Hydrochloride (Hydroxydaunomycin)
* Sulfate (Oncovin)
* Prednisone
Conditions
- Richter Syndrome
Interventions
- DRUG
-
Venetoclax is an Antineoplastic Agent; BCL-2 Inhibitor
- OTHER
-
DA-EPOCH-R
Intensive chemotherapy regiment
- OTHER
-
R-CHOP
Intensive chemotherapy regiment
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Matthew S. Davids, MD, MMSc · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-08
- Primary Completion
- 2024-12-01
- Completion
- 2027-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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