Alliance A051202: A Phase I Trial of Lenalidomide, Rituximab, and Idelalisib in Recurrent Follicular Lymphoma

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with recurrent follicular non-Hodgkin lymphoma.

Biologic therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. 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. Idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase I trial studies the side effects and the best dose of lenalidomide when giving together with rituximab and idelalisib in treating patients with recurrent follicular lymphoma.

The purpose of the study is to test the combination of the drugs lenalidomide and idelalisib at different dose levels, in combination with the drug rituximab. The study is evaluating the side effects and best dose of lenalidomide when given with rituximab and idelalisib in people with recurrent follicular lymphoma. Rituximab is FDA-approved for use in follicular lymphoma, but lenalidomide and idelalisib are not FDA-approved for treating follicular lymphoma.

Study Treatment

Treatment cycles are 21 days. Participants will receive:

  • Lenalidomide by mouth once a day on Days 1 through 21, followed by one week off, of each cycle for 12 cycles
  • Idelalisib by mouth twice a day for 12 cycles
  • Rituximab via infusion during Cycle 1 on Day 15 and 22, and on Day 1 of Cycle 2 for a total of 4 infusions

Different doses of lenalidomide will be tested in small groups of participants. The dose a participant receives will depend on when he/she enters the study. Participants who do not tolerate the initial dose of idelalisib will receive a lower dose. Following completion of study treatment, participants will be followed for up to 10 years after they enrolled in the study. 

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Disease Status and/or Stage

Recurrent Follicular non-Hodgkin Lymphoma

Sponsor

Alliance for Clinical Trials in Oncology

Key Eligibility

  • Men and women age 18 and older
  • Previously treated follicular lymphoma
  • Must have had prior treatment with rituximab either alone or in combination with chemotherapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

John Leonard, MD

Contact

Protocol ID

A051202

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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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