Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
The goal of this clinical research study is to learn if the combination of bendamustine hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.
The safety of this drug combination will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma|
- Number of Patients with Complete Response (CR) Rate [ Time Frame: At 3 months ] [ Designated as safety issue: Yes ]Number of patients with complete response (CR) rate defined as percentage of number of complete response in total number of patients treated. The trial will be conducted by the Simon's optimal two-stage design and the CR rate estimated accordingly.
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Bendamustine + Mitoxantrone + Rituximab
Bendamustine starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle. Mitoxantrone 10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m^2 by vein over several hours on Day 1 of each cycle.
Starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle.
Other Names:Drug: Mitoxantrone
10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle.
Other Name: NovantroneDrug: Rituximab
375 mg/m^2 by vein over several hours on Day 1 of each cycle.
Other Name: Rituxan
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901927
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Nathan Fowler, MD||M.D. Anderson Cancer Center|