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).
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)
Journal
Annals of oncology : official journal of the European Society for Medical Oncology
ISSN: 1569-8041
Titre abrégé: Ann Oncol
Pays: England
ID NLM: 9007735
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
received:
26
10
2021
accepted:
06
12
2021
pubmed:
20
12
2021
medline:
4
3
2022
entrez:
19
12
2021
Statut:
ppublish
Résumé
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.
Sections du résumé
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.
Identifiants
pubmed: 34923107
pii: S0923-7534(21)04876-6
doi: 10.1016/j.annonc.2021.12.003
pii:
doi:
Substances chimiques
Receptors, Antigen, T-Cell
0
Receptors, Chimeric Antigen
0
Types de publication
Practice Guideline
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
259-275Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
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.