Clinical Trial: Immunochemotherapy With Rituximab-Bendamustine-Cytarabine (R-BAC) for Patients With Mantle Cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunochemotherapy With Rituximab-Bendamustine-Cytarabine for Patients With Mantle Cell Lymphoma Not Eligible for Intensive Regimens or Autologous Transplantation.

Brief Summary: The objective of the study is to demonstrate the safety, tolerability, and activity of Rituximab-Bendamustine-Cytarabine(R-BAC) regimen in patients with mantle cell lymphoma (MCL) aged 65 years or more, as well as in younger patients who are not eligible for intensive regimens including/not including autologous transplantation.

Detailed Summary: Since Bendamustine has recently shown promising safety and efficacy in combination with monoclonal antibodies in the treatment of patients with MCL, the goal of this study is to investigate the possible therapeutic benefit of combining Ara-C with Bendamustine and Rituximab (R-BAC). All three agents exhibit individual and unique mechanisms of action in MCL, and a synergistic or additive effect might be expected when these agents are used in combination, as suggested by the pre-clinical studies.
Sponsor: St. Bortolo Hospital

Current Primary Outcome: The safety and tolerability of R-BAC treatment will be tested to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Ara-C when combined with Bendamustine and Rituximab. [ Time Frame: June 2011 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Overall response and freedom from progression after R-BAC treatment [ Time Frame: June 2011 ]

Original Secondary Outcome: Same as current

Information By: St. Bortolo Hospital

Dates:
Date Received: October 7, 2009
Date Started: June 2009
Date Completion:
Last Updated: September 25, 2012
Last Verified: September 2010