TY - JOUR
T1 - Management of Adults and Children receiving CAR T-cell therapy
T2 - 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)
AU - Hayden, P J
AU - Roddie, C
AU - Bader, P
AU - Basak, G W
AU - Bonig, H
AU - Bonini, C
AU - Chabannon, C
AU - Ciceri, F
AU - Corbacioglu, S
AU - Ellard, R
AU - Sanchez-Guijo, F
AU - Jäger, U
AU - Hildebrandt, M
AU - Hudecek, M
AU - Kersten, M J
AU - Köhl, U
AU - Kuball, J
AU - Mielke, S
AU - Mohty, M
AU - Murray, J
AU - Nagler, A
AU - Rees, J
AU - Rioufol, C
AU - Saccardi, R
AU - Snowden, J A
AU - Styczynski, J
AU - Subklewe, M
AU - Thieblemont, C
AU - Topp, M
AU - Ispizua, Á U
AU - Chen, D
AU - Vrhovac, R
AU - Gribben, J G
AU - Kröger, N
AU - Einsele, H
AU - Yakoub-Agha, I
N1 - Funding Information:
The authors thank all respondents to the international survey on the management of patients receiving CAR-T therapy and all administrative staff from EHA and EBMT who supported this initiative including Sophie Terwel. None declared. 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.
Publisher Copyright:
© 2021 The Authors
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
KW - B-cell acute lymphoblastic leukemia (B ALL)
KW - CAR T-cells
KW - cytokine release syndrome (CRS)
KW - immune effector cell associated neurotoxicity syndrome (ICANS)
KW - large B-cell lymphoma (LBCL)
KW - multiple myeloma (MM)
UR - https://www.scopus.com/pages/publications/85123279981
U2 - 10.1016/j.annonc.2021.12.003
DO - 10.1016/j.annonc.2021.12.003
M3 - Article
C2 - 34923107
SN - 0923-7534
VL - 33
SP - 259
EP - 275
JO - Annals of oncology : official journal of the European Society for Medical Oncology
JF - Annals of oncology : official journal of the European Society for Medical Oncology
IS - 3
ER -