Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor: Massachusetts General Hospital
Study ID: NCT01400685
Phase: PHASE1
Status: Completed

Conditions

B Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

Lenalidomide — DRUG
Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.
Bendamustine — DRUG
90 mg/m\^2 IV days 1-2 of each cycle for 6 cycles
Rituximab — DRUG
375 mg/m\^2 IV day 1 (cycle 1), 500 mg/m\^2 day 1 (cycles 2-6)

Study Details

Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias. In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.