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 — DRUG25 mg/m\^2 IV over 30 minutes daily for 3 days
- Cyclophosphamide — DRUG250 mg/m\^2 IV over 30 minutes daily for 3 days
- Rituximab — DRUG375 mg/m\^2 IV on Day 1 by prolonged infusion. All subsequent doses 500 mg/m\^2 IV 30-minute infusion.
- Bevacizumab — DRUG10 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 + BevacizumabFCR = 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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