[DESCAR-T, a nationwide registry for patient treated by CAR-T Cells in France]

Bull Cancer. 2021 Oct;108(10S):S143-S154. doi: 10.1016/j.bulcan.2021.07.002.
[Article in French]

Abstract

CAR-T Cells have opened new doors for cellular immunotherapies and provides new therapeutic options for patients with refractory B-cell malignancies, B-cell acute lymphoblastic leukemia and diffuse large B-cel lymphoma. CAR-T Cells have benefited from an accelerated approval procedure in many countries. Indeed, The French health authorities have approved the specialties Tisacel ® and Axicel ®, but additional data including the use of CAR-T Cells in real life were also mandatory. In regard to the scientific interest of the project, LYSA-LYSARC committed itself to prospectively and retrospectively collect information on patients eligible for CAR-T Cells as required by French health authorities. Other academic cooperating groups (GRAALL, IFM, SFCE, FILO and the scientific society SFGM-TC) were associated to this initiative which aims to build a nationwide CAR-T Cells devoted registry, so-called DESCART (Dispositif d'Enregistrement et Suivi des patients traités par CAR-T cells). DESCAR-T is a real-life multicentric registry set up in French sites qualified for CAR-T Cells treatment. DESCAR-T objective is to describe the use of CAR-T Cells in real life. All paediatric and adult patients with hematological malignancy fulfilling CAR-T Cells approval criteria and for whom a CAR-T Cells therapy has been discussed are included from 1 July 2018. Clinical data are directly collected from medical records and patients are treated according to the centers' routine practices. One of the distinctive features of DESCAR-T is its link with HTA for CAR-T Cells s reimbursement by the French public health system. DESCAR-T is the first national registry promoted by an academic group allowing centralized data collection for both academic and HTA/health authorities' purposes.

Keywords: CAR-T Cells; Hematologic malignancies; Hémopathie maligne; Real-life registry; Registre-Vie réelle.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Child
  • Data Collection / methods
  • France
  • Hematologic Neoplasms* / immunology
  • Hematologic Neoplasms* / therapy
  • Humans
  • Immunotherapy, Adoptive* / legislation & jurisprudence
  • Immunotherapy, Adoptive* / statistics & numerical data
  • Leukemia, B-Cell / immunology
  • Leukemia, B-Cell / therapy
  • Lymphoma, Large B-Cell, Diffuse / immunology
  • Lymphoma, Large B-Cell, Diffuse / therapy
  • Medical Records / statistics & numerical data
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / immunology
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma / therapy
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Receptors, Chimeric Antigen* / immunology
  • Registries* / ethics
  • Registries* / statistics & numerical data
  • T-Lymphocytes* / immunology
  • T-Lymphocytes* / transplantation
  • Young Adult

Substances

  • Receptors, Chimeric Antigen