FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)
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.
Chronic Lymphocytic Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia|
- Progression Free Survival (PFS) Rate [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Primary outcome for this trial is progression free survival. Target PFS rate is 65% of patients surviving past 2 years.
|Study Start Date:||February 2007|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: FCR + Bevacizumab
FCR = Fludarabine, Cyclophosphamide, Rituximab
25 mg/m^2 IV over 30 minutes daily for 3 days
Other Names:Drug: Cyclophosphamide
250 mg/m^2 IV over 30 minutes daily for 3 days
Other Names:Drug: Rituximab
375 mg/m^2 IV on Day 1 by prolonged infusion. All subsequent doses 500 mg/m^2 IV 30-minute infusion.
Other Name: RituxanDrug: Bevacizumab
10 mg/Kg IV on Day 3, course 1 over 30-90 minutes
During the study, you will have up to 6 "cycles" of treatment. A cycle is made up of treatment with the study drugs for 3-4 days and then about 3-1/2 weeks (25 days) of no treatment (about 4 weeks total). Treatment with the study drugs will be given for 4 days in a row on the first cycle, and 3 days in a row on Cycles 2-6. On Day 1 of each cycle, you will receive rituximab through a needle in a vein. On Cycle 1, since it is your first exposure to rituximab, it must be given slowly, so it may take 6-8 hours to complete. On the cycles after that, it can be given more rapidly, over 3-4 hours. Cyclophosphamide and fludarabine will be given separately through a needle in a vein on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2-6. Cyclophosphamide and fludarabine will each be given over 30 minutes. Bevacizumab will be given through a needle in a vein over 90 minutes on Day 3 of Cycle 1. If it is well tolerated, the next dose of Bevacizumab will be given over 60 minutes on Day 2 of Cycle 2. If the Cycle 2 dose is well tolerated, the next doses of Bevacizumab will be given over 30 minutes on Day 2 of Cycles 2-6. In addition to the study drugs, you may also be given fluids by vein to help flush the kidneys, to help prevent possible kidney damage. You may receive up to 6 cycles of treatment. Treatment will be given on an outpatient basis. The injections for each daily treatment visit should take less than 6 hours.
Up to 66 patients will take part in the study. All will be enrolled at M.D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448019
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Susan O'Brien, MD||M.D. Anderson Cancer Center|