Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
|ClinicalTrials.gov Identifier: NCT00901927|
Recruitment Status : Terminated (Study was closed early due to toxicity)
First Posted : May 14, 2009
Last Update Posted : May 27, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: Bendamustine Drug: Mitoxantrone Drug: Rituximab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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
- Number of Patients with Complete Response (CR) Rate [ Time Frame: At 3 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|