Tag: Jia Ruan MD

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.

New Developments in Lymphoma–Newsletter

The Lymphoma Program has published the inaugural issue of the New Developments in Lymphoma Newsletter.

Please look to this space for further announcements of future newsletter issues, or sign up for advance notice of the newsletter here.

ASCO 2014: Romidepsin Plus Lenalidomide is Well Tolerated for Patients with Relapsed Lymphoma and Myeloma

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By Jia Ruan, MD, PhD

At a poster session of the 2014 ASCO meeting, results of a phase I trial were presented from an ongoing, multi-center, phase I/II study testing the combination of romidepsin and lenalidomide in patients with relapsed lymphoma and myeloma. Although romidepsin and lenalidomide have both been individually approved by the FDA for the treatment of lymphoma and multiple myeloma, the combination represents a novel experimental development, based on potentially synergistic mechanism of action, and non-overlapping toxicity of the two biologic agents.

The phase I portion of the trial evaluated toxicity, maximum tolerated dose, and clinical activity of the romidepsin and lenalidomide combination. Romidepsin was given intravenously on days 1, 8, and 15 and lenalidomide was given orally on days 1-21 of a 28-day cycle. From the 13 evaluable patient responses, there was an overall response rate of 54%, complete response rate of 15%, and partial response of 39%.

From these early results the investigators concluded that the combination of romidepsin and lenalidomide is well tolerated and lacks any unexpected toxicity. Responses were consistent across multiple lymphoma subtypes, and the upcoming disease specific phase II cohorts will include B-cell lymphomas, T-cell lymphomas, and multiple myeloma.

Reference

Lunning, MA. Ruan, J. Nair, S. (2014). A phase I/II trial of the combination of romidepsin and lenalidomide in patients with relapsed/refractory lymphoma and myeloma: Phase I results. [Abstract]. J Clin Oncol, 32:5s, (suppl. abstract 8582)