Phase I Clinical Trial of Bendamustine, Lenalidomide and Rituximab in B-Cell Lymphoid Malignancies
This is a Phase I, open-label, dose-escalation study of bendamustine and lenalidomide (BL)
and also bendamustine,lenalidomide, and rituximab (BLR) in relapsed/refractory CLL and
relapsed/refractory B-cell lymphomas. Phase I dose escalation will be done independently for
the CLL and NHL groups. In addition, the study will be conducted in 2 parts. In part I of
the study, the maximum tolerated dose of bendamustine and lenalidomide will be determined
independently for the CLL and NHL groups. In part II of the study, CLL and NHL subjects
will be enrolled at the MTD of BL determined in Part I for CLL and NHL and all subjects will
receive rituximab. Part II of the study will determine the MTD of BLT independently for the
NHL and CLL groups.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
2 years
Yes
Bruce D Cheson, MD
Principal Investigator
Georgetown University
United States: Institutional Review Board
RV-CLL-NHL-PI-356
NCT00864942
February 2009
July 2014
Name | Location |
---|---|
Georgetown University Hospital/Lombardi Cancer Center | Washington, District of Columbia 20007 |