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Rituximab, bendamustine and cytarabine followed by venetoclax (V-RBAC) in high-risk elderly patients with mantle cell lymphoma (MCL)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511533-35-00
Acronym
FIL_V-RBAC
Enrollment
130
Registered
2024-09-02
Start date
2018-09-03
Completion date
2025-10-15
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma

Brief summary

2-years progression-free survival (PFS) of the HR patients from date of enrollment

Detailed description

The proportion of molecular response (analyzed in the labs of the FIL-MRD Network), The progression-free survival (PFS) of all enrolled patients, and of different subgroups (i.e TP53 mutated patients), The overall survival (OS), The duration of responses (DoR), The proportion of complete remission (CR) before and after venetoclax in the HR group and/or in the LR not responding to R-BAC., The proportion of patients that complete the expected treatment schedule, The safety of venetoclax when administered as consolidation or maintenance after R-BAC

Interventions

DRUGBENDAMUSTINE
DRUGCYTARABINE
DRUGVENETOCLAX
DRUGRITUXIMAB

Sponsors

Fondazione Italiana Linfomi Ets
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
2-years progression-free survival (PFS) of the HR patients from date of enrollment

Secondary

MeasureTime frame
The proportion of molecular response (analyzed in the labs of the FIL-MRD Network), The progression-free survival (PFS) of all enrolled patients, and of different subgroups (i.e TP53 mutated patients), The overall survival (OS), The duration of responses (DoR), The proportion of complete remission (CR) before and after venetoclax in the HR group and/or in the LR not responding to R-BAC., The proportion of patients that complete the expected treatment schedule, The safety of venetoclax when administered as consolidation or maintenance after R-BAC

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026