Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

Status: Recruiting
Phase: Phase 1
Diagnosis: Leukemia/MDS
NCT ID: NCT01400685 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-016


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.


Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Jeremy Abramson, MD, Massachusetts General Hospital

Site-responsible Investigators:
Jennifer Brown, MD, PhD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

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: - 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
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