A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma
Patients enrolling in this study will receive a maximum of six cycles of the study drugs.
Each cycle is 28 days in length. They will receive Rituximab-Bendamustine (RB) for the first
3 cycles. This treatment will consist of Rituximab given by infusion into a vein
(intravenous) on day 1 of each cycle and Bendamustine given by infusion into a vein (over
approximately 30-60 minutes) daily on days 1 and 2 of each cycle.
They will then receive Rituximab-Cytarabine (RC) for the last 3 cycles (with the first cycle
administered 28 days after the last RB cycle). This treatment will consist of Rituximab
given by infusion into a vein (intravenous) on day 1 of each cycle and cytarabine by
infusion into a vein (intravenous) every 12 hours on days 1 and 2 of each cycle. It is
expected that those 3 cycles will be delivered in the hospital, over 2-3 days each time.
It is expected that patients will proceed to autologous stem cell transplantation at the
conclusion of this study. However, the stem cell transplantation will not be performed as
part of this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Remission rate of Rituximab/Bendamustine and Rituximab/Cytarabine
CR and CRu rate of an alternating regimen of Rituximab-Bendamustine and Rituximab-Cytarabine for adult patients younger than 70 years old with untreated MCL.
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|