Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer
|Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia||Drug: fludarabine phosphate Drug: thalidomide||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine|
- Toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 [ Time Frame: Up to 5 years ]
- Incidence of complete and partial remission [ Time Frame: Up to 5 years ]
|Study Start Date:||March 2002|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Experimental: Arm I (thalidomide)
Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (thalidomide, fludarabine phosphate)
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.
Drug: fludarabine phosphate
Other Names:Drug: thalidomide
I. Compare the safety and tolerability of thalidomide with or without fludarabine in patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
II. Compare the incidence of complete and partial remission in patients treated with these regimens.
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 unacceptable toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009984
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Principal Investigator:||Richard Furman||Montefiore Medical Center|