Management of adults and children receiving CAR T-cell therapy: 2021 best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE) and the European Haematology Association (EHA)
P J Hayden, C Roddie, P Bader, G W Basak, H Bonig, C Bonini, C Chabannon, F Ciceri, S Corbacioglu, R Ellard, F Sanchez-Guijo, U Jäger, M Hildebrandt, M Hudecek, M J Kersten, U Köhl, J Kuball, S Mielke, M Mohty, J Murray, A Nagler, J Rees, C Rioufol, R Saccardi, J A Snowden, J Styczynski, M Subklewe, C Thieblemont, M Topp, Á U Ispizua, D Chen, R Vrhovac, J G Gribben, N Kröger, H Einsele, I Yakoub-Agha, P J Hayden, C Roddie, P Bader, G W Basak, H Bonig, C Bonini, C Chabannon, F Ciceri, S Corbacioglu, R Ellard, F Sanchez-Guijo, U Jäger, M Hildebrandt, M Hudecek, M J Kersten, U Köhl, J Kuball, S Mielke, M Mohty, J Murray, A Nagler, J Rees, C Rioufol, R Saccardi, J A Snowden, J Styczynski, M Subklewe, C Thieblemont, M Topp, Á U Ispizua, D Chen, R Vrhovac, J G Gribben, N Kröger, H Einsele, I Yakoub-Agha
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.
Keywords: B-cell acute lymphoblastic leukemia (B ALL); CAR T-cells; cytokine release syndrome (CRS); immune effector cell associated neurotoxicity syndrome (ICANS); large B-cell lymphoma (LBCL); multiple myeloma (MM).
Conflict of interest statement
Disclosure PJH—Janssen, Takeda, Amgen, Celgene, Alnylam. CR—Novartis, Gilead, BMS. PB—Neovii, Riemser, Medac, Novartis, Gilead, Celgene BMS, Miltenyi, Jazz, Riemser, Amgen, Servier. GWB—Kite/Gilead, Novartis, Celgene/BMS and FamicordTx. HB—Novartis and Celgene. CB—Intellia Therapeutics, TxCell, Novartis, GSK, Molmed, Kite/Gilead, Miltenyi, Kiadis, QuellTx, Janssen, Allogene. CC—Sanofi SA, Miltenyi Biotech, Fresenius Kabi, Gilead, Novartis, Celgene, Terumo BCT, Bellicum Pharmaceuticals, Janssen. RE—Kite Gilead, BMS Celgene, Janssen. FSG—Novartis, Kite/Gilead, Celgene/BMS, Pfizer, Incyte, Amgen, Takeda, and Roche. UJ—Novartis, Janssen, Gilead, BMS, Miltenyi. MH—T-CURX GmbH. MJK—BMS/Celgene, Kite/Gilead, Miltenyi Biotec, Novartis, Roche. UK—AstraZeneca, Affimed, Glycostem, GammaDelta, Zelluna. JK—Novartis, Miltenyi Biotech, Gadeta, Gilead/BMS. SM—Celgene/BMS, Novartis, DNA Prime SA, Gilead/KITE, Miltenyi, Immunicum. MM—Sanofi, Jazz, Amgen, Takeda, Novartis, Janssen, Celgene, Adaptive Biotechnologies, Astellas, Pfizer, Stemline, GSK, outside the submitted work. JM—Kite/Gilead, Jazz, Janssen, and Mallinckrodt. CR—Kite/Gilead, Novartis, Celgene/BMS, Janssen. RS—Novartis, Gilead, Janssen. JAS—Gilead, Jazz, Janssen, Mallinckrodt, Medac. JS—MSD, Gilead, Pfizer, Kite, Novartis, TEVA. MS—Amgen, Gilead, Miltenyi Biotec, Morphosys, Roche, Seattle Genetics, BMS, Celgene, Pfizer, Novartis, Roche, Janssen, Novartis. CT—BMS/Celgene, Abbvie, Takeda, Roche, Novartis, Gilead/Kyte, Incyte, Novartis, Cellectis, Amgen, Sanofi, Janssen, AstraZeneca, ADC Therapeutics. MT—Gilead/KITE, Regeneron, Roche, Novartis, Janssen, Celgene/BMS. JGG—Abbvie, Amgen, Astra Zeneca, BMS, Janssen, Kite/Gilead, Morphosys, Novartis, Takeda. NK—AOP Phama, Novartis, Amgen, Sanofi, Neovii, JAZZ, Gilead/Kite, Celgene, Riemser. HE—Janssen, BMS/Celgene, Amgen, Sanofi, GSK, Novartis, Takeda. IY-A—Kite/Gilead, Novartis, Celgene/BMS and Janssen. All other authors have declared no conflicts of interest.
Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed