Clinical Trial: Phase II Study of Age‐Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With Mantle Cell Lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional



Official Title: Phase II Study of Age‐Adjusted R‐BAC (Rituximab, Bendamustine, Cytarabine) as Induction Therapy in Older Patients With Mantle Cell Lymphoma (MCL)

Brief 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