Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study
Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4
weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on
days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV
infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on
day 1 of each cycle.
Subjects will receive routine blood tests and physical exam during each cycle. Tumor
assessments by CT scan will be performed during cycles 2, 4, and 6.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL
Jeremy Abramson, M.D.
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|