New Clinical Trials: Innovative Approaches for Follicular Lymphoma

The Weill Cornell Lymphoma Program has recently opened two clinical trials sponsored by The Alliance for Clinical Trials in Oncology. These trials are notable for their innovative approach. As Lymphoma Program Director and current chair of the committee, Dr. John Leonard explained, “Under the leadership of Bruce Cheson, MD, the lymphoma committee has been focused on ‘biologic doublets’ with targeted agents, a treatment approach that has been quite innovative. Following up on his work we are now moving toward ‘targeted triplet therapy’ which is a first in lymphoma therapeutics. These are important steps as we move such ‘chemotherapy-free’ approaches more and more into standard treatment.”

A051103 – A Phase I Study of Rituximab, Lenalidomide, and Ibrutinib in Previously Untreated Follicular Lymphoma

In the first trial, principal investigator, Dr. Peter Martin seeks to evaluate the effect of rituximab, lenalidomide, and ibrutinib in untreated follicular lymphoma. For more information about the untreated follicular lymphoma trial, please call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility
  • Untreated Follicular Lymphoma
  • No prior systemic therapy for non-Hodgkin lymphoma
  • Detailed eligibility reviewed when you contact the study team

Study Details

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.

Treatment Plan

Over the course of  each 28 day treatment cycle patients will receive lenalidomide by mouth every day on Days 1 through 21, ibrutinib by mouth on Days 1 through 28 of each cycle, and rituximab via infusion on Days 1, 8, 15, & 22 of Cycle 1 and during the first week of Cycle 4 & 6 & 10. 

Different dosses of lenalidomide and ibrutinib will be tested in small groups of participants.

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

In the second trial, principal investigator, Dr. John Leonard seeks to evaluate the effect of lenalidomide, rituximab, and idelalisib in recurrent follicular lymphoma. For more information about the recurrent follicular lymphoma trial, please call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

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

Study Details

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.

Treatment Plans

Treatment cycles are 21 days long. 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, and rituximab via infusion during Cycle 1 on Day 15 & 22, and on Day 1 of Cycle 2 for a total of 4 infusions.

Click here to view all current lymphoma trials at Weill Cornell Medical College

New Clinical Trial: Ibrutinib in Refractory Follicular Lymphoma

The Weill Cornell Lymphoma Program has recently opened a clinical trial evaluating ibrutinib in men and women with refractory follicular lymphoma. The study sponsor is Janssen Pharmaceuticals, and the principal investigator at Weill Cornell is Dr. Peter Martin. For more information about the study, please call Amelyn Rodriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility
  • Age 18 and older
  • Refractory follicular lymphoma
  • Previously treated with at least 2 prior lines of therapy
  • Did not respond to last prior therapy
  • Detailed eligibility reviewed when you contact the study team
Study Details

The purpose of the study is to evaluate the response to treatment with the experimental drug ibrutinib, also called PCI-32765. Ibrutinib is an oral drug that inhibits the enzyme Bruton’s Tyrosine Kinase (BTK), decreasing the ability of lymphoma cells to grow and survive.

Treatment Plan

All study participants will receive ibrutinib; there is no placebo. Participants will take 4 capsules by mouth once every day. Participants will continue taking ibrutinib as long as they are responding to treatment and not experiencing unacceptable side effects.

Click here to view all current lymphoma trials at Weill Cornell Medical College.

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