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Analyzing Real-World Data for CAR T-Cell Therapy in Patients With ALL and DLBCL

Marcelo C. Pasquini, MD
Published Online:2:46 PM, Mon October 7, 2019

Marcelo C. Pasquini, MD, associate professor of medicine, Medical College of Wisconsin and senior scientific director of Center for International Blood and Marrow Transplant Research (CIBMTR) Clinical Trials Support, discusses the rationale for analyzing real-world data for the use of tisagenlecleucel (Kymriah), a chimeric antigen receptor (CAR) T-cell therapy, as a treatment for patients with acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL). This CD19 CAR T cell was approved 2 years ago for use in both ALL and DLBCL.

When the FDA approved the CAR T cell, the FDA mandated that the industry develop an infrastructure to follow these patients long-term as part of the approval process. There were concerns over whether these patients would develop secondary malignancies in the process of manufacturing the cells, so patients had to be followed for 15 years.

The CIBMTR developed an infrastructure to capture follow-up of these patients, says Pasquini. One year ago, a prospective, observational study began to look at the effect of this CAR T-cell therapy in patients with either ALL or DLBCL. Patients have been enrolled now for less than a year, but this is the first study to compare how real-world evidence shapes up to the use of this product, Pasquini concludes.
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