Tag: cancer clinical trials

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

Clinical Trials FAQ

Are you interested in participating in a lymphoma clinical trial, but unsure of what a clinical trial encompasses?

If so, then please click here for our recently added Clinical Trials FAQ. This page is useful for addressing the concerns and misconceptions regarding clinical trials by outlining their basic structure and requirements in the Lymphoma Program at Weill Cornell Medical College.

Here at Weill Cornell we are dedicated to providing the best in patient care, while working towards the ultimate goal of finding a cure for lymphoma. Clinical trials are one of the many tools we use to help accomplish these dual goals. For a full listing of all current clinical trials underway in the Lymphoma Program, please click here.

Rally for Medical Research: Help Protect Funding for Medical Research

On April 8, 2012 thousands of individuals and nearly 200 partnering programs, including representatives from the American Society of Hematology (ASH), American Society of Clinical Oncology (ASCO), and American Association of Cancer Research (AACR) gathered at the Carnegie Library grounds in Washington, D.C. for the Rally for Medical Research. Here medical research supporters sought to raise public awareness over the importance of federally funded medical research. This need has been magnified by the March 1 sequestration mandated cuts to all areas of the federal budget, and a decade long decline in funding for the National Institute of Health (NIH).

As ASH wrote, this decline in money for medical research is not a new development:

“Research supported by the National Institutes of Health (NIH) is in serious jeopardy. NIH’s inflation-adjusted budget today is almost 20 percent lower than it was in FY 2003…Under sequestration, the NIH budget will be cut by an additional $1.6 billion over the remainder of fiscal year (FY) 2013. While the impact of these cuts may not be felt all at once or immediately, the harm caused to bio-medical research will be devastating- progress toward cures for deadly diseases and efforts to prevent costly chronic conditions will be slowed…”

Besides these  budgetary concerns, ASCO President Sandra M. Swain noted the human cost of such budget cuts, stressing the impressive strides made in cancer research due to federal funding:

“As a direct result of the federal investment in cancer research, we understand more about cancers than at any point in human history. This understanding of cancer at the molecular level has created unprecedented opportunities to slow the growth of cancer diseases. As a country, we can be proud that two of three people in the U.S. with cancer live at least 5 years after their diagnosis. This is up from one of two in the 1970s before the passage of the National Cancer Act. Since the 1990s, the nation’s cancer death rate has dropped 18 percent, reversing decades of increases. More than 13 million people in the U.S. are cancer survivors.”

Considering these new fiscal realities, the researchers and clinicians in the Lymphoma Program at Weill Cornell Medical College are adjusting accordingly. They will continue to do all that they can to deliver the latest in ground breaking research and clinical care.

Click here to use the ASH advocacy tool to contact your Representative and Senators about protecting medical research. Contact information for individual Representatives and Senators can be found here and here.