Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT01400685

Run by

Massachusetts General Hospital

People needed

34

Starts

2012-12-01

Expected to finish

2018-01-01

Last updated by the study team

2018-01-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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