Phase II Study of Age-Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With MCL

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT01662050
Phase
PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab, Bendamustine, Cytarabine. — DRUG
    6 cycles of 28 days with Rituximab, Bendamustine and Cytarabine (R-BAC). Rituximab 375mg/mq; Bendamustine 70mg/mq; Cytarabine 500mg/mq.

Study Details

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

Key Dates

Start date
Mar 20, 2012
Status verified
Aug 2022
Primary completion
Aug 31, 2014
Completion
Sep 11, 2017

Study Design

Enrollment
57 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: One arm for all patients.
    Rituximab, Bendamustine, Cytarabine

Primary Outcome Measure

complete remission rate at the end of treatment [ Time Frame: 6 months ]

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