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

No results posted yet for this study

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

Venetoclax

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

  • AbbVie

    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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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567876 on ClinicalTrials.gov