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.
Interventional
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
2 years
Yes
Jeremy Abramson, M.D.
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
11-016
NCT01400685
December 2012
November 2013
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |