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


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

Peter Martin, MD


Protocol ID


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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]

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