P J Hayden1, C Roddie2, P Bader3, G W Basak4, H Bonig5, C Bonini6, C Chabannon7, F Ciceri8, S Corbacioglu9, R Ellard10, F Sanchez-Guijo11, U Jäger12, M Hildebrandt13, M Hudecek14, M J Kersten15, U Köhl16, J Kuball17, S Mielke18, M Mohty19, J Murray20, A Nagler21, J Rees22, C Rioufol23, R Saccardi24, J A Snowden25, J Styczynski26, M Subklewe27, C Thieblemont28, M Topp14, Á U Ispizua29, D Chen30, R Vrhovac31, J G Gribben32, N Kröger33, H Einsele14, I Yakoub-Agha34. 1. Department of Haematology, Trinity College Dublin, St. James's Hospital, Dublin, Ireland. 2. UCL Cancer Institute, London, UK; University College London Hospital NHS Foundation Trust, London, UK. Electronic address: c.roddie@ucl.ac.uk. 3. Clinic for Children and Adolescents, University Children's Hospital, Frankfurt, Germany. 4. Medical University of Warsaw, Department of Hematology, Transplantation and Internal Medicine, Warsaw, Poland. 5. Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Service, Frankfurt, Germany. 6. Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy. 7. Aix-Marseille université, Inserm CBT-1409, Institut Paoli-Calmettes, centre de thérapie cellulaire, unité de transplantation et de thérapie cellulaire, département de biologie du cancer, Marseille, France. 8. Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan, Italy. 9. Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Franz-Josef-Strauss-Allee 11, University Hospital of Regensburg, Regensburg, Germany. 10. Royal Marsden Hospital, Fulham Rd, London, UK. 11. IBSAL-Hospital Universitario de Salamanca, CIC, Universidad de Salamanca, Salamanca, Spain. 12. Clinical Department for Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria. 13. Department of Transfusion Medicine, Cell Therapeutics and Haemostaseology, LMU University Hospital Grosshadern, Munich. 14. Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany. 15. Department of Hematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam and LYMMCARE, Amsterdam, the Netherlands. 16. Fraunhofer Institute for Cell Therapy and Immunology (IZI) and Institute of Clinical Immunology, University of Leipzig, Leipzig, Germany; Institute of Cellular Therapeutics, Hannover Medical School, Hannover, Germany. 17. Department of Hematology and Centre for Translational Immunology, University Medical Center Utrecht, Utrecht, the Netherlands. 18. Karolinska Institutet and University Hospital, Department of Laboratory Medicine/Department of Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Stockholm, Sweden. 19. Hôpital Saint-Antoine, APHP, Sorbonne Université, INSERM UMRs 938, Paris, France. 20. Christie Hospital NHS Trust, Manchester, UK. 21. The Chaim Sheba Medical Center, Tel-Hashomer, affiliated with the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel. 22. University College London Hospital NHS Foundation Trust, London, UK; UCL Institute of Neurology, University College of London Hospitals NHS Foundation Trust, London, UK. 23. Hospices Civils de Lyon, UCBL1, EMR 3738 CICLY, Lyon, France. 24. Cell Therapy and Transfusion Medicine Department, Careggi University Hospital, Florence, Italy. 25. Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. 26. Department of Pediatric Hematology and Oncology, Collegium Medicum, Nicolaus Copernicus University Torun, Bydgoszcz, Poland. 27. German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany. 28. AP-HP, Saint-Louis Hospital, Hemato-oncology, University of Paris, Paris, France. 29. Department of Hematology, ICMHO, Hospital Clínic de Barcelona, Barcelona, Spain. 30. University College London Hospital NHS Foundation Trust, London, UK; Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK. 31. Department of Haematology, University Hospital Centre Zagreb, Zagreb, Croatia. 32. Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK. 33. Department of Stem Cell Transplantation, University Medical Center Hamburg, Germany. 34. CHU de Lille, Univ Lille, INSERM U1286, Infinite, Lille, France.
Abstract
BACKGROUND: 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. DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.