Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine
OBJECTIVES:
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.
Interventional
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
Yes
Richard Furman
Principal Investigator
Montefiore Medical Center
United States: Food and Drug Administration
NCI-2012-02393
NCT00009984
March 2002
Name | Location |
---|---|
Montefiore Medical Center | Bronx, New York 10467-2490 |