Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
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|ClinicalTrials.gov Identifier: NCT01400685|
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : January 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma B Chronic Lymphocytic Leukemia||Drug: Lenalidomide Drug: Bendamustine Drug: Rituximab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||January 2018|
- Drug: Lenalidomide
Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.Other Names:
- Drug: Bendamustine
90 mg/m^2 IV days 1-2 of each cycle for 6 cyclesOther Names:
- SDX 105
- Drug: Rituximab
375 mg/m^2 IV day 1 (cycle 1), 500 mg/m^2 day 1 (cycles 2-6)Other Names:
- Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL [ Time Frame: 2 years ]
- Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL [ Time Frame: 2 year ]
- Clinical efficacy [ Time Frame: 2 years ]response rate, progression-free and overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400685
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jeremy Abramson, M.D.||Massachusetts General Hospital|