Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine
I. Compare the safety and tolerability of thalidomide with or without fludarabine in
patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic
II. Compare the incidence of complete and partial remission in patients treated with these
OUTLINE: This is a randomized, open-label study. Patients are stratified according to time
to relapse from last fludarabine treatment (less than 6 months vs more than 6 months).
Patients are randomized to one of two treatment arms.
Arm I: Patients receive oral thalidomide once daily in the absence of disease progression or
Arm II: Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days
1-5. Treatment with fludarabine repeats every 28 days for 6 courses. Once fludarabine is
completed, patients continue to receive thalidomide alone as in arm I.
PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per treatment arm) will be accrued for
this study within 1 year.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Up to 5 years
Montefiore Medical Center
United States: Food and Drug Administration
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