Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01096992
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bendamustine — DRUG
    Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine) Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)
  • Fludarabine — DRUG
    Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3
  • Rituximab — DRUG
    Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1

Study Details

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.

Key Dates

Start date
Apr 19, 2010
Status verified
Sep 2019
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 20 mg/m^2
    Bendamustine, Fludarabine + Rituximab
  • Experimental: Phase 2
    Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
  • Experimental: Phase 1 30 mg/m^2
    Bendamustine, Fludarabine + Rituximab
  • Experimental: Phase 1 40 mg/m^2
    Bendamustine, Fludarabine + Rituximab
  • Experimental: Phase 1 50 mg/m^2
    Bendamustine, Fludarabine + Rituximab

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR) [ Time Frame: After 4 week cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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