A051103: A Phase I Study of Rituximab, Lenalidomide, and Ibrutinib in Previously Untreated Follicular Lymphoma
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with follicular non-Hodgkin lymphoma who have not been previously treated.
The purpose of the study is to test the combination of the drugs lenalidomide and ibrutinib (also called PCI-32765) at different dose levels, in combination with the drug rituximab. The study is evaluating the side effects and best dose of lenalidomide and ibrutinib for combination with rituximab in previously untreated follicular lymphoma.
Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide and ibrutinib together with rituximab may be an effective treatment for follicular lymphoma.
Study Treatment
Treatment cycles are 28 days. Participants will receive:
- Lenalidomide by mouth every day on Days 1 through 21 of each cycle, followed by one week off
- Ibrutinib by mouth every day on Days 1 through 28 of each cycle
- Rituximab via infusion on Days 1, 8, 15 and 22 of Cycle 1; during the first week of Cycle 4, the first week of Cycle 6, and the first week of Cycle 10
Different doses of lenalidomide and ibrutinib will be tested in small groups of participants. The doses a participant receives will depend on when he/she joins the trial. Participants will continue on treatment for as long as they are responding to therapy and not experiencing unacceptable side effects.
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Disease Status and/or Stage
Untreated Follicular Lymphoma
Sponsor
Alliance for Clinical Trials in Oncology
Key Eligibility
- Untreated Follicular Lymphoma
- No prior systemic therapy for non-Hodgkin lymphoma
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Amelyn Rodriguez, RN
- (212) 746-1362
- [email protected]
Protocol ID
A051103
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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]