[A standardized medical report template for CAR T-Cell therapy patients: Guidelines of the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)]. / Lettre type pour les comptes rendus « CAR-T Cells ¼ : recommandations de la Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC).

Tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™) are the first representatives of a new class of gene therapies produced by ex-vivo genetic modification of human autologous T lymphocytes, now using viral vectors. In 2020, there are three independent CAR-T cell databases in France: DESCAR-T (database supported by LYSARC, GRAALL and the IFM), ProMISe (EBMT database) and ATIH (database of the Agence Technique de l'Information sur l'Hospitalisation). Only the EBMT database is common to France and the French-speaking countries that are members of the SFGM-TC. In 2019, a workshop was held to draft a manual for entering data specific to CAR-T cells in the EBMT ProMISe database. As a follow-up to this article, we present a medical report template containing all the data required to enter the data of patients treated with CAR-T in the EBMT registry, in the CRF of the DESCAR-T registry and in the ATIH registry. This document aims to improve the completeness and quality of the data while optimizing data entry time.

[Reporting data of patients receiving CAR T cell therapy into the EBMT registry: Guidelines of the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)]. / Saisie des données des patients faisant l'objet d'un traitement par cellules CAR-T : recommandations de la Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC).

Tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™) are the first two approved drug products that belong to of a new class of therapies manufactured through an industrial process that includes the ex vivo genetic modification of human autologous T lymphocytes with viral vectors. Since CAR-T Cells qualify as gene therapy medicinal products, there is a requirement for long-term (15 years) follow-up of treated patients. As part of a global initiative aiming at a better use of continental registries to study the outcome of homogeneous groups of patients, EMA issued a positive opinion on the use of the EBMT registry to capture LTFU of patients treated with CAR-T Cell in EU Member states. The use of a European registry will provide a global view of this new field across EU countries and across diverse indications, and bears advantages over the use of registries dedicated to specific categories of diseases, or national registries. This is an important asset to fully measure the medical value of these innovative therapies in real-life conditions, and assess whether pricing is fully justified. To fulfill EMA requirements, as well as requirements from Pharma companies, EBMT has designed a new Cellular Therapy Med-A form that allows to capture the essential information on the administered drug product, disease and patient. Registering patients and capturing follow-up data is already possible in Promise, and will be made easier when the full migration of the EBMT database from Promise to MACRO is completed in the forthcoming weeks. Negotiations are ongoing with all interested parties including patients to define in which conditions data will be accessed and analyzed; the underlying principle is to favor rather than restrict the use of data, with a view to build cooperative projects involving relevant cooperative groups and professional associations. Here, we present practical recommendations issued by SFGM-TC to help data managers capture information related to patients treated with CAR-T Cells.

[Stem cell transplantation unit: Guidelines from the francophone Society of bone marrow transplantation and cellular therapy (SFGM-TC)]. / Unité de greffe : recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC).

Allogeneic hematopoietic cell transplantation (HCT) is part of the standard of care for many hematological diseases. Over the last decades, significant advances in patient and donor selection, conditioning regimens as well as supportive care of patients undergoing allogeneic HCT leading to improved overall survival have been made. In view of many new treatment options in cellular and molecular targeted therapies, the place of allogeneic transplantation in therapy concepts must be reviewed. Most aspects of HCT are well standardized by national guidelines or laws as well as by certification labels such as FACT-JACIE. However, the requirements for human resources, construction and layout of a unit treating patients during the transplantation procedure and for different complications are not well defined. Here, we describe the process of planning a transplant unit in order to open a discussion that could lead to more precise guidelines in the field of personnel and infrastructural requirements for hospitals caring for people with severe immunosuppression.