NCT01400685

Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma
• B Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
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.
DRUG	Bendamustine	90 mg/m\^2 IV days 1-2 of each cycle for 6 cycles
DRUG	Rituximab	375 mg/m\^2 IV day 1 (cycle 1), 500 mg/m\^2 day 1 (cycles 2-6)

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2011-07-22
• Last updated: 2018-01-25

Locations

2 sites across 1 country: United States