Tag: lenalidomide

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

ICML Update: Lenalidomide and Rituximab Are Well Tolerated and Effective in Patients with Previously Untreated Follicular Lymphoma

On June 20, at the 12th International Conference on Malignant Lymphoma, Dr. Peter Martin presented preliminary results from the CALGB-sponsored phase II study of oral lenalidomide plus rituximab in patients with previously untreated follicular lymphoma. Although preliminary, the overall and complete response rates were promising (93% and 72%, respectively) and the regimen was well tolerated. Moreover, these results are comparable to standard chemotherapy-containing regimens and provide rationale for further development of non-chemotherapy treatments for patients with follicular lymphoma. Shortly we will begin conducting a trial of lenalidomide, rituximab, and ibrutinib in patients with previously untreated follicular lymphoma and hope to improve even further on these results.

Please look back to this space for further updates regarding future trials with lenalidomide, rituximab, and ibrutinib.

ASCO 2013: Single-agent Lenalidomide Produces Promising Results in Relapsed/Refractory Mantle Cell Lymphoma

jruanBy Jia Ruan, MD, PhD

Mantle cell lymphoma (MCL) is an aggressive non-Hodgkin lymphoma (NHL) characterized by a short remission duration to standard therapies, poor prognosis, and median overall survival of 4-5 years. The immunomodulatory agent lenalidomide has consistently exhibited a tolerable level of safety in multiple phase II studies of relapsed/refractory aggressive NHL and MCL post-bortezomib.  At the recent 2013 annual meeting of the American Society of Clinical Oncology, Dr. Thomas E. Witzig of the Mayo Clinic presented results from a combined analysis of multiple phase II trials testing the efficacy and safety of single-agent lenalidomide in relapsed/refractory MCL patients.

Of the 206 patients with relapsed/refractory MCL the overall response rate with lenalidomide was 32%, with a median time to response of 2.1 months and median duration of response of 16.6 months. Kaplan-Meier estimates for median progression free survival and overall survival were 5.4 and 23.9 months, respectively. Mean daily dose of lenalidomide was 21 mg.  Grade 3/4 adverse events included neutropenia (44%), thrombocytopenia (29%), anemia (11%), and fatigue (7%), other side effects included tumor flare reaction (7%), venous thromboembolic events (7%), and invasive second primary malignancies (3%).

This study adds to the growing body of literature supporting the promise of lenalidomide for treating patients with MCL.  At the Weill Cornell Lymphoma Program these breakthroughs are augmented by our own trials exploring the utility of lenalidomide in treating patients with MCL.

Update: this study is closed to enrollment. 

The Weill Cornell Lymphoma Program is now enrolling patients in a new, investigator-initiated phase II study of lenalidomide in combination with rituximab in patients with previously untreated MCL (NCT01472562). The purpose of the study is to test the synergy of combining lenalidomide, a biological agent that targets the tumor micro-environment, with rituximab, an antibody that targets lymphoma cells. By including a maintenance phase of lenalidomide and rituximab therapy, we hope to improve treatment effectiveness and maintain quality of life for patients.

This is an outpatient treatment strategy because lenalidomide, the study medication, can be taken at home.  After the first month on study, patients will be seen in clinic on average once a month.  The study has two phases:

Induction Phase, Weeks 1-48:

  •  Treatment dose lenalidomide taken by mouth on days 1-21 of a 28-day cycle for 12 cycles
  •  Rituximab infusion for a total of 9 doses

Maintenance Phase, Week 49 until disease progression or for a maximum of 5 years from study entry:

  • Maintenance dose lenalidominde taken by mouth on days 1-21 of a 28-day cycle
  • Rituximab infusion one dose every 8 weeks