Tag: follicular lymphoma

Zydelig Approved by FDA for Patients with CLL, FL, & SLL

Earlier this afternoon the FDA announced the approval of Zydelig (idelalisib) for patients with relapsed chronic lymphocytic leukemia (CLL). Accelerated approval was also granted for the use of  Zydelig in patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). According to the FDA press release:

“Zydelig’s safety and effectiveness to treat relapsed CLL were established in a clinical trial of 220 participants who were randomly assigned to receive Zydelig and Rituxan or placebo and Rituxan. The trial was stopped for efficacy following the first pre-specified interim analysis point, which showed participants treated with Zydelig and Rituxan lived 10.7 months without their disease progressing (progression-free survival) compared to about 5.5 months for participants treated with placebo and Rituxan. Results from a second interim analysis continued to show a statistically significant improvement for Zydelig and Rituxan over placebo and Rituxan.”

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“Zydelig’s safety and effectiveness to treat relapsed FL and relapsed SLL were established in a clinical trial with 123 participants with slow-growing (indolent) non-Hodgkin lymphomas. All participants were treated with Zydelig and were evaluated for complete or partial disappearance of their cancer after treatment (objective response rate, or ORR). Results showed 54 percent of participants with relapsed FL and 58 percent of participants with SLL experienced ORR.”

Commenting on this welcomed development Dr. Richard Furman said, “We are very excited to have idelalisib to add to our armentarium of agents that are now available for use and would like to thank all of the patients and their families who made this possible by participating in the clinical trials.” Look to this blog and our clinical trials page for further developments regarding the use of Zydelig in the treatment of CLL, FL, & SLL patients.

ASCO 2014: Promising Results with Lenalidomide Plus Rituximab for Patients with Previously Untreated Follicular Lymphoma

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By Peter Martin, MD

On May 30, 2014, at the 50th annual meeting of the American Society of Clinical Oncology (ASCO) I had the pleasure of presenting updated, preliminary results from the multi-center, national cooperative group CALGB 50803 phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma. This trial represents an important step as we move away from traditional cytotoxic chemotherapy towards a future with novel, better-tolerated regimens for treatment of patients with follicular lymphoma.

Patients in this trial received oral lenalidomide on days 1-21 of each 28-day cycle for a total of twelve cycles plus four weekly infusions of rituximab during cycle 1 followed by four additional infusions at the start of cycles 4, 6, 8, and 10. The primary objective was to measure the patient’s complete response rate. Overall, we found that the regimen was well tolerated, with very low rates of infection or other significant adverse events. Preliminary data from patients evaluable for complete response suggests that over 90% of patients responded, including roughly 70% complete responses. At two years, 89% of patients continued to respond. These efficacy data are consistent with what is typically seen with cytotoxic chemotherapy-based regimens and they support further evaluation of lenalidomide plus rituximab compared to chemotherapy in an ongoing phase III trial.

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