Lenalidomide + Rituximab for Chronic Lymphocytic Leukemia
Trial Summary
What is the purpose of this trial?
The goal of this clinical research study is to learn if the combination of lenalidomide and rituximab can help to control CLL. The safety of this drug combination will also be studied.Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
Research Team
Alessandra Ferrajoli, MD,BS
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), either untreated and needing treatment but not suitable for chemoimmunotherapy, or those previously treated. Participants must have proper kidney and liver function, be in a stable health condition, not pregnant, willing to follow birth control requirements if applicable, and free from other serious illnesses.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenalidomide and rituximab in 28-day cycles. Rituximab is administered weekly during Cycle 1, not given in Cycle 2, and then on Day 1 of Cycles 3-12. Lenalidomide is taken daily starting Day 9 of Cycle 1.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Bone marrow biopsy and aspiration are performed at the end of Cycles 3, 6, and 12.
Extension
Participants may continue treatment beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response.
Treatment Details
Interventions
- Lenalidomide
- Rituximab
Lenalidomide is already approved in European Union, United States for the following indications:
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Celgene Corporation
Industry Sponsor
Mark Alles
Celgene Corporation
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania
Sol J. Barer
Celgene Corporation
Chief Medical Officer since 2006
PhD in Organic and Physical Chemistry from Rutgers University