Tag: clinical trials

New Clinical Trial: Efficacy of Autologous EBV-specific T cells for the Treatment of Patients with Aggressive Extranodal NK/T-cell Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with extranodal NK/T-cell lymphoma. The study sponsor is Cell Medica, and the principal investigator at Weill Cornell is Dr. Jia Ruan. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older
  • Non-Hodgkin lymphoma called extranodal NK/T-cell lymphoma
  • Disease has not gone away with treatment, or has come back
  • Detailed eligibility reviewed when you contact the study team

Study Details

The purpose of this study is to find out more about the safety and effects of giving CMD-003 (EBV T-cells, an investigational new product) to treat participants with extranodal natural killer T-cell lymphoma (NK/T-cell lymphoma).

In this study the investigational EBV specific T-cell product is grown from the participant’s own blood.  Investigational means that it is being testing and has not been approved by Regulatory Agencies like the United States Food and Drug Administration (FDA).

Treatment Plans

There will be two phases in the study, the screening phase and the treatment phase. In the screening phase, the study doctor will need to take some of the participant’s blood and send it to a laboratory to manufacture the experimental autologous T-cell product. This manufacturing process will take about 35 days.

The treatment phase will consist of up to 5 CMD-003 T-cell doses given intravenously (into the veins) for about 10 minutes over 6 months. Participants will be seen by the study doctor at 8 regular study visits over a one year period. The study doctor will check how the cancer responds to the EBV T cell treatment with standard imaging. Some additional blood samples will be taken to check how the body is reacting to the drug.

FDA Approves Ibrutinib for Chronic Lymphocytic Leukemia

Last week the FDA announced the approval of ibrutinib for patients with chronic lymphocytic leukemia. According to their press release:

“The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.”

“CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells. The National Cancer Institute estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013.”

“Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy.”

“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.”

 The full press release can be read on their website. 

The full listing of CLL trials at WCMC is available on the clinical trials website. Look to this space for further news concerning  ibrutinib trials for CLL patients at WCMC.

Idelalisib Study for CLL Patients Ended Early Due to Positive Findings

On October 9, Gilead Sciences Inc., announced an exciting new development for CLL patients. An independent Data Monitoring Committee (DMC) recommended that a Phase 3 study of Idelalisib in previously-treated CLL patients be ended early, due to evidence of efficacy. As Gilead noted,

“This DMC recommendation is based on a predefined interim analysis showing highly statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those receiving rituximab alone. The safety profile of idelalisib was acceptable and consistent with prior experience in combination with rituximab in previously treated CLL. Gilead has informed the U.S. Food and Drug Administration (FDA) of the plan to end the study and will engage in a dialogue with the FDA regarding a regulatory filing in CLL.”

Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President , Research and Development and Chief Scientific Officer explained,

“This is the first Phase 3 study to report positive results for a new class of targeted therapies that inhibit B-cell receptor signaling as a major component of their mechanism of action, an important area of focus in the development of chemotherapy-free regimens in CLL and other B-cell malignancies. We extend thanks to the investigative sites and to the other research collaborators participating in this study, as well as to the patients who volunteered, and we look forward to sharing these data with the hematology community.”

Prominent researchers involved in this study include the Lymphoma Program’s Dr. Richard Furman. Further data from this study will be submitted for upcoming scientific conferences. Please look to this space to follow up with any further announcements regarding this new development.

 Gilead’s full press release can be found here.