A Phase II Study of Lenalidomide Revlimid(Registered Trademark) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
There is evidence that lenalidomide has single agent activity in chronic lymphocytic
leukemia (CLL)/small lymphocytic leukemia (SLL. Optimal dosing of lenalidomide in CLL has
not been established yet. A pilot clinical trial in CLL studied single agent lenalidomide
cycled every 4 weeks with 25 mg for three weeks on and one week off drug. In this trial dose
reductions have been necessary secondary to prolonged neutropenia or thrombocytopenia in a
majority of patients. However, there was also remarkable efficacy and evidence for an immune
stimulatory effect of lenalidomide. Therefore, we propose this phase II trial using 20 mg
lenalidomide (Revlimid(Registered Trademark)) 3 weeks on and 3 weeks off for 4 cycles in
subjects who have been previously treated for chronic lymphocytic leukemia (CLL)/small
lymphocytic leukemia (SLL). Subjects with at least PR may go on to receive 4 additional
cycles.
The primary objective of the trial is to test the efficacy of a more tolerable dosing scheme
of lenalidomide.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The response rate to lenalidomide (Revlimid) in subjects with CLL/SLL.
United States: Federal Government
070104
NCT00439231
February 2007
November 2010
Name | Location |
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National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |