Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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