Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

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.

Inclusion criteria

• Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic leukemia)
• Life expectancy > 3 months
• Organ and marrow function with protocol parameters
• Able to take aspirin daily

Exclusion criteria

• Age >80 years
• Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy
• Pregnant or breast-feeding
• Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent
• Known hypersensitivity to thalidomide or lenalidomide
• Prior use of lenalidomide
• Concurrent use of other anti-cancer agents or treatments
• HIV positive
• Prior history of another malignancy unless disease free for at least 2 years
• Uncontrolled intercurrent illness