作者
Patrick Hayden,Claire Roddie,Peter Bader,Grzegorz W. Basak,Halvard Bönig,Chiara Bonini,Christian Chabannon,Fabio Ciceri,Selim Corbacioglu,Rose Ellard,Fermín Sánchez‐Guijo,Ulrich Jäger,Michelle A.T. Hildebrandt,Michael Hudecek,Marie José Kersten,Ulrike Köhl,Jürgen Kuball,Stephan Mielke,Mohamad Mohty,John Murray,Arnon Nagler,Jeremy Rees,Catherine Rioufol,Riccardo Saccardi,John A. Snowden,Jan Styczyński,Marion Subklewe,Catherine Thiéblemont,Max S. Topp,A Urbano Ispizua,D. Chen,Radovan Vrḫovac,John G. Gribben,Nicolaus Kröger,Hermann Einsele,Ibrahim Yakoub‐Agha
摘要
Several commercial and academic autologous chimeric antigen receptor T-cell (CAR-T) products targeting CD19 have been approved in Europe for relapsed/refractory B-cell acute lymphoblastic leukemia, high-grade B-cell lymphoma and mantle cell lymphoma. Products for other diseases such as multiple myeloma and follicular lymphoma are likely to be approved by the European Medicines Agency in the near future.The European Society for Blood and Marrow Transplantation (EBMT)-Joint Accreditation Committee of ISCT and EBMT (JACIE) and the European Haematology Association collaborated to draft best practice recommendations based on the current literature to support health care professionals in delivering consistent, high-quality care in this rapidly moving field.Thirty-six CAR-T experts (medical, nursing, pharmacy/laboratory) assembled to draft recommendations to cover all aspects of CAR-T patient care and supply chain management, from patient selection to long-term follow-up, post-authorisation safety surveillance and regulatory issues.We provide practical, clinically relevant recommendations on the use of these high-cost, logistically complex therapies for haematologists/oncologists, nurses and other stakeholders including pharmacists and health sector administrators involved in the delivery of CAR-T in the clinic.