Phase II study of age-adjusted R-BAC (Rituximab, Bendamustine, Cytarabine) as induction therapy in older patients with Mantle Cell Lymphoma (MCL)
Obiettivi, struttura e articolazione dello Studio
Disegno dello Studio
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.
Dimensione del campione
Numero di Centri e localizzazione dello Studio
57 Centri in Italia
Durata dello Studio
54 sulla base delle seguenti assunzioni:
- Reclutamento: 24 mesi
- Massimo periodo di trattamento: 6 mesi
- Follow up: 24 mesi
Data di inizio dello Studio