A Phase II Study of Daily Alternating Thalidomide and Lenalidomide Therapy Plus Rituximab (THRiL) as Initial Treatment for Patients with CLL
Study Status
Open to Enrollment
Study Description
The purpose of this study is to investigate the effectiveness of the combination of thalidomide, lenalidomide and rituximab (THRiL) as treatment for patients with untreated chronic lymphocytic leukemia (CLL).
Current standard treatments for patients with CLL involve the use of chemotherapy or immunotherapy, either alone or in combination. While these treatment regimens are effective, they are not curative and have side effects. In earlier studies, both thalidomide and lenalidomide, which may work by interfering with substances that help support the growth of cancer cells, have demonstrated efficacy in patients with relapsed and refractory CLL. The use of thalidomide and lenalidomide are limited by toxicities, including sedation, constipation, and neuropathy for thalidomide and tumor flare and low blood counts for lenalidomide. Since both therapies work through similar mechanisms of action, the schedule of alternating the daily dosing thalidomide and lenalidomide may result in better tolerability by decreasing each of the agent’s side effects, while preserving efficacy.
Thalidomide is approved by the FDA as treatment for newly diagnosed patients with multiple myeloma. Lenalidomide is approved by the FDA as a treatment for specific types of myelodysplastic syndrome (MDS) and multiple myeloma. The use of thalidomide and lenalidomide as treatment for chronic lymphocytic leukemia is considered experimental.
Before beginning treatment with the combination regimen, patients will receive a two-week course of single agent thalidomide or lenalidomide followed by no treatment for 2 weeks. Patients will be assigned to take either thalidomide or lenalidomide depending on when they enroll in the study.
Patients will then receive thalidomide every other day, alternating with lenalidomide, for a 28-day cycle. Each cycle will be 28 days in length. Rituximab will be administered on days 1, 8, 15 and 22 of Cycle 1 and on the same weekly x 4 schedule every 6th cycle thereafter (Cycles 7, 13, 19, etc).
Patients will continue to receive thalidomide and lenalidomide until their disease progresses.
Disease Status and/or Stage
Untreated CLL
Sponsor
Weill Cornell Medical College
Key Eligibility
- Men and women age 18 or older
- Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) No prior therapy for CLL, including treatment for autoimmune conditions that have developed since initial diagnosis of CLL
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Amelyn Rodriguez, RN
- (212) 746-1362
- [email protected]
- Weill Cornell Lymphoma Center
- (646) 962-2700
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
