Weill Cornell Breakthrough Research: Shutting Down DLBCL Master Protein; Potential for New Treatments

Reporting in Nature Immunology, Weill Cornell’s Dr. Ari Melnick and his research team have reported an important research breakthrough in diffuse large-B cell lymphoma (DLBCL) that may offer hope for new treatments for aggressive lymphomas.

Dr. Melnick has found that it is possible to shut down the protein Bcl6, a powerful master regulatory transcription factor that is the key to survival for many aggressive lymphomas arising from the B-cells.

“The finding comes as a very welcome surprise,” says the study’s lead investigator, Dr. Ari Melnick, Gebroe Family Professor of Hematology/Oncology and director of the Raymond and Beverly Sackler Center for Biomedical and Physical Sciences at Weill Cornell.

The protein Bcl6 was previously considered too complex to target with individual drugs, because of its centrality in the functioning of the body’s healthy immune cells.

“This means the drugs we have developed against Bcl6 are more likely to be significantly less toxic and safer for patients with this cancer than we realized,” says Dr. Melnick.

DLBCL is the most common subtype of non-Hodgkin lymphoma — the seventh most frequently diagnosed cancer, with many patients resistant to currently available treatments. Presently, there are ongoing clinical trials for those suffering from non-Hodgkin’s lymphoma and other forms of lymphoma at the Weill Cornell Lymphoma Center.

The full press release can be read here.

Ibrutinib Granted Breakthrough Status by FDA for Two B-Cell Malignancies

On February 12, the FDA granted a Breakthrough Therapy Designation for the investigational agent ibrutinib in the treatment of mantle cell lymphoma and Waldenstrom’s macroglobulinemia. This designation is awarded to drugs whose preliminary clinical evidence suggests an improvement over existing therapies on one or more clinically significant endpoints. Enacted as part of the 2012 FDA Safety and Innovation Act, the Breakthrough Therapy Designations were conceived to help speed along the drug development process, drastically decreasing the time between clinical trials and final regulatory approval.

Ibrutinib, an oral drug designed to specifically target an enzyme called Bruton’s tyrosine kinase (BTK), has demonstrated promising activity in multiple phase 1 and 2 clinical trials performed at Weill Cornell Medical College and around the world. As one of the leading institutions in the study of ibrutinib since its first trials 3 years ago, Weill Cornell is uniquely positioned in its experience with ibrutinib.

Currently, there are ongoing ibrutinib clinical trials at the Weill Cornell Lymphoma Center open to patients with CLL and mantle cell lymphoma. Please stay updated with our clinical trials listing for forthcoming trials with ibrutinib.

Investigator-Initiated Trial: Sequential Regimen of Intensive Chemotherapy Followed by Stem Cell Transplant for Refractory Lymphoma

Update: this study is closed to enrollment. 

The Weill Cornell Hematologic Malignancies & Bone Marrow Transplant Program is now enrolling men and women with relapsed or refractory lymphoma (non-Hodgkin or Hodgkin) and who are in need of a stem cell transplant for an investigator-initiated clinical trial. The principal investigator is Tsiporah B. Shore, M.D. For more information about the study, please call June Greenberg, RN at (212) 746-2651, e-mail June at jdg2002@med.cornell.edu, or call the Bone Marrow Transplant Program at (212) 746-2119.

Study Details

This clinical trial is for men and women whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant.

The purpose of the study is to test the safety and effectiveness of giving the drug Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell transplant for lymphoma that has not achieved a complete response to salvage chemotherapy (treatment used for relapsed disease).

Bendamustine is FDA-approved for the treatment of Chronic Lymphocytic Leukemia. Although Bendamustine has been used in stem cell research studies, the timing and combination of Bendamustine and the conditioning regimen BEAM (carmustine, etoposide, cytarabine arabinoside, and melphalan) prior to transplant is not approved by the FDA, thus the combination therapy used in this research study is considered experimental.

Autologous stem cell transplants refer to stem cells that are collected from an individual and given back to that same individual after high dose chemotherapy. With this type of transplant, the person’s stem cells are obtained prior to high-dose chemotherapy, frozen, stored-if necessary, and then given back afterward. Allogeneic stem cell transplantation refers to stem cells that are collected from a donor.

Treatment Plan

Study participants will receive Continue reading “Investigator-Initiated Trial: Sequential Regimen of Intensive Chemotherapy Followed by Stem Cell Transplant for Refractory Lymphoma”