FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00448019
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Fludarabine — DRUG
    25 mg/m\^2 IV over 30 minutes daily for 3 days
  • Cyclophosphamide — DRUG
    250 mg/m\^2 IV over 30 minutes daily for 3 days
  • Rituximab — DRUG
    375 mg/m\^2 IV on Day 1 by prolonged infusion. All subsequent doses 500 mg/m\^2 IV 30-minute infusion.
  • Bevacizumab — DRUG
    10 mg/Kg IV on Day 3, course 1 over 30-90 minutes

Study Details

The goal of this clinical research study is to learn if the combination of fludarabine, cyclophosphamide, rituximab, and bevacizumab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy. The safety of this treatment will also be studied.

Key Dates

Start date
Feb 28, 2007
Status verified
Oct 2015
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

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

Arms

  • Experimental: FCR + Bevacizumab
    FCR = Fludarabine 25 mg/m\^2 intravenous (IV) , Cyclophosphamide 250 mg/m\^2 IV daily for 3 days, Rituximab 375 mg/m\^2 IV Day 1, followed by 500 mg/m\^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.

Primary Outcome Measure

Progression Free Survival (PFS) Rate [ Time Frame: Baseline up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition

Related Studies