Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
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.
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
B Chronic Lymphocytic Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study|
- Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
- Clinical efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]response rate, progression-free and overall survival
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
- SDX 105
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400685
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||Jeremy Abramson, M.D.||Massachusetts General Hospital|