Phase II study of age-adjusted R-BAC (Rituximab, Bendamustine, Cytarabine) as induction therapy in older patients with Mantle Cell Lymphoma (MCL)
Objectives, structure and design of the Study
This is a two stage Phase 2, non-randomized, prospective multicenter study.
Patients with Mantle Cell Lymphoma who satisfy the inclusion criteria will be treated with at least two cycles of Rituximab-Bendamustine-Cytarabine (RBAC500), recycling every 28 days. Patients with PD after 2 cycles will stop treatment, while all other patients will continue treatment. After 4 cycles patients that had SD after 2 cycles will be reevaluated for response and they will stop treatment if still in SD or PD. Responsive patients (CR, Cru, PR after 2 cycles; SD after 2 cycles that improved their response at the end of cycle 4) will receive a total of 6 cycles. Patients experiencing at least one episode of relevant toxicity during any of the first 4 cycles will be treated with a total of four cycles (end of treatment after 4 cycles) regardless of response to treatment.
To determine the activity (complete remission rate according to Cheson 2007 criteria) and safety of age-adjusted RBAC500 regimen at the end of treatment in older untreated patients with MCL.
The secondary objectives are to determine:
- The rate of molecular response (characterized by labs of the FIL)
- The progression-free survival (PFS)
- The overall survival (OS)
- The duration of responses (DOR)
- The rate of patients that complete the expected treatment schedule (6 courses)
- The rate of patients that are subject to dose reductions or delays
Patients with an established histological diagnosis of MCL on lymph-node biopsy, bone marrow biopsy, or extranodal tissue are eligible for entry into the study.
Number of Centers and location of the Study
57 Centers in Italy
54 based on the following assumptions:
- Recruitment: 24 months
- Maximum treatment period: 6 months
- Follow-up: 24 months
Study start date