Clinical Trial Participation May Improve Outcomes for Patients with Lymphoma

Picture1By Peter Martin, M.D.

Recently researchers from the Mayo Clinic presented data at the 2016 ASCO annual meeting suggesting that clinical trial participation might be associated with a survival benefit. The researchers used the Mayo Clinic Lymphoma Database to identify patients with relapsed Hodgkin lymphoma (HL), diffuse large B-cell lymphoma (DLBCL), or relapsed mantle cell lymphoma (MCL), and compared the characteristics and outcomes of those enrolled in clinical trials versus those who were eligible, but not enrolled in clinical trials. Between January 2001 and December 2014, 340 patients with DLBCL, 159 with MCL, and 115 patients with HL were identified. Over this same period 47 unique Phase 1-3 trials led to the FDA approval of 17 treatments.

94 of 340 (27%) DLBCL, 63 of 159 (41%) MCL and 66 of 115 (57%) HL patients were enrolled on a clinical trial at some point during therapy, with 38% of patients enrolled in more than 1 study. Researchers found that the median survival of patients treated in a clinical trial was roughly twice as long as patients not treated on a clinical trial in all 3 lymphoma subtypes. There are several possible sources of bias or confounding that might explain the difference, despite the researchers’ efforts to control for these variables. Clearly, more research in this areas is indicated. Nonetheless, the magnitude of benefit was striking and should be reassuring to patients considering clinical trial participation.

Dr. Peter Martin Describes a Copanlisib Trial for Mantle Cell Lymphoma Patients who have Previously Failed Ibrutinib Treatment

In this video Dr. Peter Martin describes the benefits of a recently opened clinical trial evaluating the efficacy and safety of copanlisib for mantle cell lymphoma (MCL) patients, who have failed or were unable to tolerate ibrutinib treatment. The purpose of this study is to to evaluate the efficacy and safety of copanlisib monotherapy in patients with MCL.

If you’re interested in participating in this trial please call 212-746-2919 for more information. A full listing of MCL trials at Weill Cornell Medicine can be found here.

New Drug Combination Displays Promise for the Treatment of Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a B-cell non-Hodgkin lymphoma that primarily affects elderly patients. Due to the age of these patients and associated medical conditions, they are often less able to tolerate chemotherapy regimens. Still those patients who are eligible for chemotherapy frequently relapse, and require further treatment. However, clinicians in the Lymphoma Program at Weill Cornell Medicine recently published results from a clinical trial that combined the non-chemotherapy alternatives of lenalidomide and rituximab as an initial treatment for patients with MCL.

These findings were published online Nov. 4 and in the Nov. 5 print issue of the New England Journal of Medicine. They demonstrate that the combination of lenalidomide and rituximab provides an effective alternative to chemotherapy for MCL patients. Over 90% of patients enrolled in the trial responded to the therapy, with long term outcomes at the 2 year mark remaining steady in 85% of patients. During treatment patients maintained a high quality of life and were able to participate in daily activities like work, travel, and standard social activities.

The lead author of the study Dr. Jia Ruan an associate professor of clinical medicine and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. She commented on the results,

 “For patients, their quality of life was preserved or improved, and that’s a huge step up from regular chemotherapy…With this frontline treatment, we were able to achieve a very high quality and durable response rate without needing to use chemotherapy. It’s very meaningful for the patients who have always been told that their disease is without a cure.”

She continued on the benefits of this  treatment combination when compared to other treatments,

“Conventional, intensive treatment may be out of reach or undesirable for many MCL patients, who often receive less intensive or palliative care that is of limited benefit. This inspired us to look for a less toxic, biological option with novel drugs that could be easily administered and more widely applicable.”

The senior author of the study Dr. John Leonard, a professor of medicine, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at the Joan and Sanford I. Weill Department of Medicine, associate dean for clinical research, and associate director of clinical trials at the Meyer Cancer Center at Weill Cornell Medicine commented on the trial,

“I’m inspired by the fact that patients are enthusiastic about this approach. I’m also excited that lymphoma physicians are thinking out of the box, that many in the community now think that a non-chemotherapy-based paradigm with novel agents is something important to take forward and more broadly assess.”

Clinical trials like this exemplify the bench to bedside approach taken in the Lymphoma Program at Weill Cornell Medicine. Look to this space for future updates on MCL, and treatment with this new combination. A listing of available clinical trials for MCL can be found on our Joint Clinical Trials website.

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