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)

• DOI: 10.1016/j.annonc.2021.12.003
• Publication Date: 2021-12-16T10:35:42Z
• Authors: 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
• Keywords: JACIE; Adult; CAR T-cells; Macrophage activation syndrome (MAS); B-cell acute lymphoblastic leukemia (B ALL); Mantle cell lymphoma (MCL); Receptors, Antigen, T-Cell; Immunotherapy, Adoptive; Accreditation; B-cell acute lymphoblastic leukemia (B-ALL); 03 medical and health sciences; 0302 clinical medicine; Bone Marrow; long-term follow-up (LTFU); CAR T-cell therapy ; best practice recommendations; Humans; multiple myeloma (MM); Multiple myeloma (MM); large B-cell lymphoma (LBCL); CAR T-cells (CAR-T); adult relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL); Receptors, Chimeric Antigen; Hematology; 3. Good health; follicular lymphoma (FL); Oncology; Practice Guideline; immune effector cell associated neurotoxicity syndrome (ICANS); immune effector cell-associated neurotoxicity syndrome (ICANS); cytokine release syndrome (CRS)

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.