Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL
NCT03567876 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141
Last updated 2025-12-08
Summary
Prospective, multicenter, phase II trial designed to evaluate whether the addition of Venetoclax after rituximab, bendamustine and cytarabine (R-BAC) to high risk patients with mantle cell lymphoma improves the results of the standard R-BAC, in terms of Progression Free Survival.
Conditions
- Lymphoma, Mantle-Cell
Interventions
- DRUG
-
Consolidation and maintenance phases with Venetoclax (for a total of 2 years) after an induction phase R-BAC (up to 6 cycles for law risk patients and up to 4 cycles for high risk patients)
Sponsors & Collaborators
- collaborator INDUSTRY
-
Fondazione Italiana Linfomi - ETS
lead OTHER
Principal Investigators
-
Carlo Visco, MD · AOU Integrata di Verona - U.O. Ematologia -Verona -Italy
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-03
- Primary Completion
- 2021-07-26
- Completion
- 2025-10-15
Countries
- Italy
Study Locations
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