Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

New Clinical Trial: Efficacy of ACP-196 in Patients with Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with diffuse large B-cell lymphoma. The study sponsor is Acerta Pharma BV, 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 greater than or equal to 18 years of age
  • Confirmed de novo ABC DLBCL, and subjects must have archival tissue available for central pathology review
  • Recurrence of disease after a complete response or progressive disease at the completion of the treatment regimen preceding entry to the study
  • Detailed eligibility will be reviewed when you contact the study team

Study Details

The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ACP-196 in treating subjects relapsed or refractory de novo ABC diffuse large B-cell lymphoma (DLBCL).

Clinical Studies have shown that targeting the B-cell receptor (BCR) signaling pathway by inhibiting Bruton tyrosine kinase (Btk) produces significant clinical benefit in patients with non-Hodgkin lymphoma. Acerta Pharma BV has developed a novel second generation Btk inhibitor, ACP-196, that achieves significant oral bioavailability and potency.

Treatment Plans

This study is a multi-center, open-label, randomized, parallel group study. No placebo will be administered during this study. Twenty subjects, 10 refractory and 10 relapsed, will be enrolled and will take 100 mg of ACP-196 twice per day.

Treatment will occur for 5 cycles with a 30 day follow-up period following the last dose. Treatment with ACP-196 may be continued for more than 28 days until disease progression or an unacceptable drug-related toxicity occurs. Subjects with disease progression will be removed from the study. All subjects who discontinue study drug will have a safety follow-up visit 30 (±7) days after the last dose of study drug unless they have started another cancer therapy within that time frame.

 

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.

The Precision Medicine Approach at WCMC Explained

In a recent article from the The Magazine of Weill Cornell Medical College and Weill Cornell Graduate School of Medical Sciences, physicians and scientists from the Lymphoma Program explained their approach to treating lymphoma. Dr. John Leonard explained,

“You shouldn’t treat everybody who walks in the door the same way. We want to treat with a tailored approach based on what’s most likely to work for that individual patient.”

…

Blood cancers have been at the forefront of research on tailored approaches to treatment, known as precision medicine. In large measure, these advancements are due to researchers’ ability to access tumor material from such patients more readily than they can with other types of cancer. In the past decade, Weill Cornell researchers have been involved in developing or testing almost every new lymphoma drug recently approved by the FDA. While most cancers today are treated primarily through surgery and radiation, Leonard notes, cancers of the blood are different. “Lymphoma is a disease where treating with drugs is central to curing the patient,” he says.

The entire article can be read here.