Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00901927
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Bendamustine — DRUG
    Starting dose 90 mg/m\^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle.
  • Mitoxantrone — DRUG
    10 mg/m\^2 by vein over 15 minutes on Day 2 of each cycle.
  • Rituximab — DRUG
    375 mg/m\^2 by vein over several hours on Day 1 of each cycle.

Study Details

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.

Key Dates

Start date
May 31, 2009
Status verified
Apr 2020
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016

Study Design

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

Arms

  • Experimental: Bendamustine + Mitoxantrone + Rituximab
    Bendamustine starting dose 90 mg/m\^2 intravenously (IV) over 30-60 minutes on Days 1 and 2 of each 8-day cycle. Mitoxantrone 10 mg/m\^2 IV over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m\^2 IV over several hours on Day 1 of each cycle.

Primary Outcome Measure

Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab) [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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University of Texas MD Anderson Cancer Center· Houston, TX

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