Author Affiliations
- Ibrahim Yakoub-Agha1,
- Christian Chabannon2,
- Peter Bader3,
- Grzegorz W. Basak4,
- Halvard Bonig5,
- Fabio Ciceri6,
- Selim Corbacioglu7,
- Rafael F. Duarte8,
- Hermann Einsele9,
- Michael Hudecek9,
- Marie José Kersten10,
- Ulrike Köhl11,
- Jürgen Kuball12,
- Stephan Mielke13,
- Mohamad Mohty14,
- John Murray15,
- Arnon Nagler16,
- Stephen Robinson17,
- Riccardo Saccardi18,
- Fermin Sanchez-Guijo19,
- John A. Snowden20,
- Micha Srour21,
- Jan Styczynski22,
- Alvaro Urbano-Ispizua23,
- Patrick J. Hayden24,* and
- Nicolaus Kröger25
- 1 CHU de Lille, Université de Lille, Lille, France;
- 2 Institut Paoli-Calmettes and Module Biotherapies, Centre Investigations Cliniques,Marseille,France;
- 3 Clinic for children and adolescents, University Children's Hospital, Frankfurt, Germany;
- 4 Dept, of Hematology, Oncology & Internal Medicine, Medical University of Warsaw, Poland;
- 5 Goethe University and German Red Cross Blood Service, Frankfurt, Germany;
- 6 Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan, Italy;
- 7 University Hospital of Regensburg, Germany;
- 8 Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain;
- 9 University of Würzburg, Germany;
- 10 Department of Hematology, AMC-Academic Medical Center, Amsterdam, The Netherlands;
- 11 Institute for Cellular Therapeutics, Hannover Medical School, Hannover, Germany;
- 12 Department of Hematology, University Medical Center Utrecht, Germany;
- 13 Department of Laboratory Medicine, Karolinska Institutet and University Hospital, Stockholm, Sweden;
- 14 Hôpital Saint-Antoine, APHP, Sorbonne Université, Paris, France;
- 15 Christie Hospital NHS Trust, Manchester, United Kingdom;
- 16 Chaim Sheba Medical Center, Tel-Aviv University, Tel-Aviv, Israel;
- 17 University Hospitals Bristol NHS Foundation Trust, Bristol, UK;
- 18 Haematology Department, Careggi University Hospital, Florence, Italy;
- 19 IBSAL-Hospital Universitario de Salamanca, Salamanca, Spain;
- 20 Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK;
- 21 Service des Maladies du Sang, CHU de Lille, Lille, France;
- 22 Dept. of Pediatric Hematology and Oncology, Nicolaus Copernicus University Torun, Bydgoszcz, Poland;
- 23 Department of Hematology, ICMHO, Hospital Clínic de Barcelona, Vilarroel, Barcelona, Spain;
- 24 Dept. of Haematology, Trinity College Dublin, St. James Hospital, Dublin, Ireland;
- 25 Department of Stem Cell Transplantation, University Medical Center Hamburg, Germany
- ↵* Corresponding author; email: phayden{at}stjames.ie
Abstract
Chimeric antigen receptor T-cells are a novel class of anti-cancer therapy in which autologous or allogeneic T-cells are engineered to express a chimeric antigen receptor targeting a membrane antigen. In Europe, Tisagenlecleucel (KymriahTM) is approved for the treatment of refractory/relapsed Acute Lymphoblastic Leukaemia in children and young adults as well as relapsed/refractory Diffuse Large B-cell Lymphoma; Axicabtagene ciloleucel (YescartaTM) is approved for the treatment of relapsed/refractory high-grade B-cell Lymphoma and Primary Mediastinal B-cell Lymphoma. Both agents are genetically engineered autologous T-cells targeting CD19. These practical recommendations, prepared under the auspices of the European Society of Blood and Marrow Transplantation, relate to patient care and supply chain management under the following headings: patient eligibility, screening laboratory tests and imaging and work-up prior to leukapheresis, how to perform leukapheresis, bridging therapy, lymphodepleting conditioning, product receipt and thawing, infusion of chimeric antigen receptor T-cells, short-term complications including cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, antibiotic prophylaxis, medium-term complications including cytopenias and B-cell aplasia, nursing and psychological patient support, long-term follow-up, post-authorisation safety surveillance, and regulatory issues. These recommendations are not prescriptive and are intended as guidance in the use of this novel therapeutic class.
- Received June 16, 2019.
- Accepted November 19, 2019.
- Copyright © 2019, Ferrata Storti Foundation