Phase II Study of Age-Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With MCL
Status:
Completed
Trial end date:
2017-03-08
Target enrollment:
Participant gender:
Summary
A phase 2 study of standard R-BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara-c 800
mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several
regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma
(MCL). An interim analysis conducted on 30 patients showed that rituximab + bendamustine +
ara-c combination had very good clinical activity, but a quite relevant hematological
toxicity, especially in previously treated and older patients (Visco C, ICML 2011 Lugano
Conference, Poster 236).
Objectives:
The primary objective is to determine the activity (complete remission rate according to
Cheson 2007 criteria) and safety of age-adjusted Rituximab-Bendamustine-Cytarabine (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