Lenalidomide Approved for Mantle Cell Lymphoma Patients by FDA

Today, June 5 the FDA approved lenalidomide capsules for the treatment of patients with mantle cell lymphoma (MCL), who have experienced relapse or progression after receiving two prior therapies including bortezomib.

According to the FDA press release:

“The approval was based a single-arm, multicenter clinical trial enrolling 134 patients with mantle cell lymphoma who have relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. All 134 patients received prior treatment with bortezomib and 60% were documented to have disease refractory to bortezomib therapy. Patients received a median of 4 prior therapies for MCL. The median age was 67 years, 81% were male, 96% were Caucasian, and 61% had MCL for at least 3 years.

The efficacy endpoints were overall response rate (ORR) and duration of response (DOR). The ORR was defined as the proportion of patients whose best response was complete response (CR), complete response unconfirmed (CRu), or partial response (PR). In the 133 patients who were evaluable for efficacy, the ORR was 26% (95% CI: 18.4, 33.9). CR or CRu was achieved by 9 patients (7%) and 25 patients (19%) achieved a PR. The median DOR for the 34 patients who achieved a CR, CRu, or PR was 16.6 months (95% CI: 7.7, 26.7).”

Here at the Weill Cornell Lymphoma Program we will endeavor to follow up with any further announcement regarding this new development.

Weill Cornell’s Dr. John Leonard Named Chair of NCI’s Alliance for Clinical Trials in Oncology Lymphoma Committee

Weill Cornell’s Dr. John Leonard has been named chair of the Lymphoma Committee for the prestigious Alliance for Clinical Trials in Oncology, sponsored by the National Cancer Institute (NCI).

John Leonard, MD
John Leonard, MD

Dr. Leonard is the Associate Dean for Clinical Research at Weill Cornell Medical College, the director of the Joint Clinical Trials Office at NewYork-Presbyterian Hospital/Weill Cornell Medical College, and the clinical director of the Weill Cornell Lymphoma Program. An internationally-recognized hematology and oncology expert specializing in the treatment of lymphoma, Dr. Leonard has been a pioneer in the development of novel lymphoma therapeutics. .

In his role as chair of the NCI-sponsored Lymphoma Committee, Dr. Leonard will help guide the national agenda for lymphoma research by developing, supporting and shepherding Phase II and Phase III clinical trials funded by NCI at medical centers around the United States. Dr. Leonard will direct a team of lymphoma clinical and laboratory researchers from academic and community medical centers across the country to create and implement new standards of treatment as well as foster the development of novel therapeutics.

“I am honored and deeply humbled to be chosen to lead this vital national effort to improve cancer care for patients in the United States,” said Dr. Leonard. “This appointment, I believe, is a true reflection of the programs and major accomplishments we’ve made here at Weill Cornell in advancing lymphoma research and clinical care. We are recognized as a leading center internationally in contributing new approaches to lymphoma management, and I am excited to continue collaborating with colleagues both here and across the country to move the field forward and improve the effectiveness of therapies that are available for patients.”

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.