Management of adults and children undergoing chimeric antigen receptor T-cell therapy: best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE)
Identifieur interne : 000289 ( 2020/Analysis ); précédent : 000288; suivant : 000290Management of adults and children undergoing chimeric antigen receptor T-cell therapy: best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE)
Auteurs : Ibrahim Yakoub-Agha [France] ; Christian Chabannon [France] ; Peter Bader [Allemagne] ; Grzegorz W. Basak [Pologne] ; Halvard Bonig [Allemagne] ; Fabio Ciceri [Italie] ; Selim Corbacioglu [Allemagne] ; Rafael F. Duarte [Espagne] ; Hermann Einsele [Allemagne] ; Michael Hudecek [Allemagne] ; Marie José Kersten [Pays-Bas] ; Ulrike Köhl [Allemagne] ; Jürgen Kuball [Pays-Bas] ; Stephan Mielke [Suède] ; Mohamad Mohty [France] ; John Murray [Royaume-Uni] ; Arnon Nagler [Israël] ; Stephen Robinson [Royaume-Uni] ; Riccardo Saccardi [Italie] ; Fermin Sanchez-Guijo [Espagne] ; John A. Snowden [Royaume-Uni] ; Micha Srour [France] ; Jan Styczynski [Pologne] ; Alvaro Urbano-Ispizua [Espagne] ; Patrick J. Hayden [Irlande (pays)] ; Nicolaus Kröger [Allemagne]Source :
- Haematologica [ 0390-6078 ] ; 2020.
Abstract
Chimeric antigen receptor (CAR) T cells are a novel class of anti-cancer therapy in which autologous or allogeneic T cells are engineered to express a CAR targeting a membrane antigen. In Europe, tisagenlecleucel (Kymriah™) is approved for the treatment of refractory/relapsed acute lymphoblastic leukemia in children and young adults as well as relapsed/refractory diffuse large B-cell lymphoma, while axicabtagene ciloleucel (Yescarta™) 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 CAR 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 support for patients, long-term follow-up, post-authorization safety surveillance, and regulatory issues. These recommendations are not prescriptive and are intended as guidance in the use of this novel therapeutic class.
Url:
DOI: 10.3324/haematol.2019.229781
PubMed: 31753925
PubMed Central: 7012497
Affiliations:
- Allemagne, Espagne, France, Irlande (pays), Israël, Italie, Pays-Bas, Pologne, Royaume-Uni, Suède
- Angleterre, Basse-Saxe, Bavière, Catalogne, Communauté de Madrid, District de Basse-Franconie, District de Darmstadt, Grand Manchester, Hambourg, Hauts-de-France, Hesse (Land), Hollande-Septentrionale, Lombardie, Nord-Pas-de-Calais, Provence-Alpes-Côte d'Azur, Svealand, Utrecht (province), Île-de-France
- Amsterdam, Barcelone, Francfort-sur-le-Main, Hambourg, Hanovre, Lille, Madrid, Manchester, Marseille, Milan, Paris, Stockholm, Utrecht, Wurtzbourg
- Université d'Amsterdam
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PMC:7012497Le document en format XML
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Basak</name><affiliation wicri:level="1"><nlm:aff id="af4-1050297">Department of Hematology, Oncology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland</nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Hematology, Oncology and Internal Medicine, Medical University of Warsaw, Warsaw</wicri:regionArea><wicri:noRegion>Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Bonig, Halvard" sort="Bonig, Halvard" uniqKey="Bonig H" first="Halvard" last="Bonig">Halvard Bonig</name><affiliation wicri:level="3"><nlm:aff id="af5-1050297">Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Service, Frankfurt, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Service, Frankfurt</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Ciceri, Fabio" sort="Ciceri, Fabio" uniqKey="Ciceri F" first="Fabio" last="Ciceri">Fabio Ciceri</name><affiliation wicri:level="3"><nlm:aff id="af6-1050297">Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Corbacioglu, Selim" sort="Corbacioglu, Selim" uniqKey="Corbacioglu S" first="Selim" last="Corbacioglu">Selim Corbacioglu</name><affiliation wicri:level="1"><nlm:aff id="af7-1050297">Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital of Regensburg, Regensburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital of Regensburg, Regensburg</wicri:regionArea><wicri:noRegion>Regensburg</wicri:noRegion><wicri:noRegion>Regensburg</wicri:noRegion><wicri:noRegion>Regensburg</wicri:noRegion></affiliation></author><author><name sortKey="Duarte, Rafael F" sort="Duarte, Rafael F" uniqKey="Duarte R" first="Rafael F." last="Duarte">Rafael F. Duarte</name><affiliation wicri:level="3"><nlm:aff id="af8-1050297">Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Universitario Puerta de Hierro Majadahonda, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation wicri:level="3"><nlm:aff id="af9-1050297">Medizinische Klinikund Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medizinische Klinikund Poliklinik II, Universitätsklinikum Würzburg, Würzburg</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Hudecek, Michael" sort="Hudecek, Michael" uniqKey="Hudecek M" first="Michael" last="Hudecek">Michael Hudecek</name><affiliation wicri:level="3"><nlm:aff id="af9-1050297">Medizinische Klinikund Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medizinische Klinikund Poliklinik II, Universitätsklinikum Würzburg, Würzburg</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Kersten, Marie Jose" sort="Kersten, Marie Jose" uniqKey="Kersten M" first="Marie José" last="Kersten">Marie José Kersten</name><affiliation wicri:level="4"><nlm:aff id="af10-1050297">Department of Hematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam and LYMMCARE, Amsterdam, the Netherlands</nlm:aff><country xml:lang="fr" wicri:curation="lc">Pays-Bas</country><wicri:regionArea>Department of Hematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam and LYMMCARE, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName><orgName type="university">Université d'Amsterdam</orgName></affiliation></author><author><name sortKey="Kohl, Ulrike" sort="Kohl, Ulrike" uniqKey="Kohl U" first="Ulrike" last="Köhl">Ulrike Köhl</name><affiliation wicri:level="3"><nlm:aff id="af11-1050297">Fraunhofer Institute for Cellular Therapeutics and Immunology (IZI) and Institute of Clinical Immunology, University of Leipzig, Leipzig as well as Institute for Cellular Therapeutics, Hannover Medical School, Hannover, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Fraunhofer Institute for Cellular Therapeutics and Immunology (IZI) and Institute of Clinical Immunology, University of Leipzig, Leipzig as well as Institute for Cellular Therapeutics, Hannover Medical School, Hannover</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation></author><author><name sortKey="Kuball, Jurgen" sort="Kuball, Jurgen" uniqKey="Kuball J" first="Jürgen" last="Kuball">Jürgen Kuball</name><affiliation wicri:level="3"><nlm:aff id="af12-1050297">Department of Hematology and Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, the Netherlands</nlm:aff><country xml:lang="fr" wicri:curation="lc">Pays-Bas</country><wicri:regionArea>Department of Hematology and Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Mielke, Stephan" sort="Mielke, Stephan" uniqKey="Mielke S" first="Stephan" last="Mielke">Stephan Mielke</name><affiliation wicri:level="3"><nlm:aff id="af13-1050297">Department of Laboratory Medicine/Department of Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska Institutet and University Hospital, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Laboratory Medicine/Department of Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska Institutet and University Hospital, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Mohty, Mohamad" sort="Mohty, Mohamad" uniqKey="Mohty M" first="Mohamad" last="Mohty">Mohamad Mohty</name><affiliation wicri:level="3"><nlm:aff id="af14-1050297">Hôpital Saint-Antoine, AP-HP, Sorbonne Université, INSERM UMRS 938, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Saint-Antoine, AP-HP, Sorbonne Université, INSERM UMRS 938, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Murray, John" sort="Murray, John" uniqKey="Murray J" first="John" last="Murray">John Murray</name><affiliation wicri:level="3"><nlm:aff id="af15-1050297">Christie Hospital NHS Trust, Manchester, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Christie Hospital NHS Trust, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation></author><author><name sortKey="Nagler, Arnon" sort="Nagler, Arnon" uniqKey="Nagler A" first="Arnon" last="Nagler">Arnon Nagler</name><affiliation wicri:level="1"><nlm:aff id="af16-1050297">The Chaim Sheba Medical Center, Tel-Hashomer, Affiliated with the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel</nlm:aff><country xml:lang="fr">Israël</country><wicri:regionArea>The Chaim Sheba Medical Center, Tel-Hashomer, Affiliated with the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv</wicri:regionArea><wicri:noRegion>Tel-Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Robinson, Stephen" sort="Robinson, Stephen" uniqKey="Robinson S" first="Stephen" last="Robinson">Stephen Robinson</name><affiliation wicri:level="1"><nlm:aff id="af17-1050297">University Hospitals Bristol NHS Foundation Trust, Bristol, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University Hospitals Bristol NHS Foundation Trust, Bristol</wicri:regionArea><wicri:noRegion>Bristol</wicri:noRegion></affiliation></author><author><name sortKey="Saccardi, Riccardo" sort="Saccardi, Riccardo" uniqKey="Saccardi R" first="Riccardo" last="Saccardi">Riccardo Saccardi</name><affiliation wicri:level="1"><nlm:aff id="af18-1050297">Hematology Department, Careggi University Hospital, Florence, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Hematology Department, Careggi University Hospital, Florence</wicri:regionArea><wicri:noRegion>Florence</wicri:noRegion></affiliation></author><author><name sortKey="Sanchez Guijo, Fermin" sort="Sanchez Guijo, Fermin" uniqKey="Sanchez Guijo F" first="Fermin" last="Sanchez-Guijo">Fermin Sanchez-Guijo</name><affiliation wicri:level="1"><nlm:aff id="af19-1050297">IBSAL-Hospital Universitario de Salamanca, CIC, Universidad de Salamanca, Salamanca, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>IBSAL-Hospital Universitario de Salamanca, CIC, Universidad de Salamanca, Salamanca</wicri:regionArea><wicri:noRegion>Salamanca</wicri:noRegion></affiliation></author><author><name sortKey="Snowden, John A" sort="Snowden, John A" uniqKey="Snowden J" first="John A." last="Snowden">John A. Snowden</name><affiliation wicri:level="1"><nlm:aff id="af20-1050297">Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield</wicri:regionArea><wicri:noRegion>Sheffield</wicri:noRegion></affiliation></author><author><name sortKey="Srour, Micha" sort="Srour, Micha" uniqKey="Srour M" first="Micha" last="Srour">Micha Srour</name><affiliation wicri:level="3"><nlm:aff id="af21-1050297">Service des Maladies du Sang, CHU de Lille, Lille, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Service des Maladies du Sang, CHU de Lille, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Styczynski, Jan" sort="Styczynski, Jan" uniqKey="Styczynski J" first="Jan" last="Styczynski">Jan Styczynski</name><affiliation wicri:level="1"><nlm:aff id="af22-1050297">Department of Pediatric Hematology and Oncology, Collegium Medicum, Nicolaus Copernicus University Torun, Bydgoszcz, Poland</nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Pediatric Hematology and Oncology, Collegium Medicum, Nicolaus Copernicus University Torun, Bydgoszcz</wicri:regionArea><wicri:noRegion>Bydgoszcz</wicri:noRegion></affiliation></author><author><name sortKey="Urbano Ispizua, Alvaro" sort="Urbano Ispizua, Alvaro" uniqKey="Urbano Ispizua A" first="Alvaro" last="Urbano-Ispizua">Alvaro Urbano-Ispizua</name><affiliation wicri:level="3"><nlm:aff id="af23-1050297">Department of Hematology, ICMHO, Hospital Clínic de Barcelona, Barcelona, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Hematology, ICMHO, Hospital Clínic de Barcelona, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Hayden, Patrick J" sort="Hayden, Patrick J" uniqKey="Hayden P" first="Patrick J." last="Hayden">Patrick J. Hayden</name><affiliation wicri:level="1"><nlm:aff id="af24-1050297">Department. of Hematology, Trinity College Dublin, St. James’s Hospital, Dublin, Ireland</nlm:aff><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Department. of Hematology, Trinity College Dublin, St. James’s Hospital, Dublin</wicri:regionArea><wicri:noRegion>Dublin</wicri:noRegion></affiliation></author><author><name sortKey="Kroger, Nicolaus" sort="Kroger, Nicolaus" uniqKey="Kroger N" first="Nicolaus" last="Kröger">Nicolaus Kröger</name><affiliation wicri:level="3"><nlm:aff id="af25-1050297">Department of Stem Cell Transplantation, University Medical Center Hamburg, Hamburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Stem Cell Transplantation, University Medical Center Hamburg, Hamburg</wicri:regionArea><placeName><settlement type="city">Hambourg</settlement><region type="land" nuts="2">Hambourg</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">31753925</idno><idno type="pmc">7012497</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7012497</idno><idno type="RBID">PMC:7012497</idno><idno type="doi">10.3324/haematol.2019.229781</idno><date when="2020">2020</date><idno type="wicri:Area/Pmc/Corpus">000B01</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000B01</idno><idno type="wicri:Area/Pmc/Curation">000B01</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000B01</idno><idno type="wicri:Area/Pmc/Checkpoint">000199</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000199</idno><idno type="wicri:Area/Ncbi/Merge">002584</idno><idno type="wicri:Area/Ncbi/Curation">002584</idno><idno type="wicri:Area/Ncbi/Checkpoint">002584</idno><idno type="wicri:doubleKey">0390-6078:2020:Yakoub Agha I:management:of:adults</idno><idno type="wicri:Area/Main/Merge">000289</idno><idno type="wicri:Area/Main/Curation">000289</idno><idno type="wicri:Area/Main/Exploration">000289</idno><idno type="wicri:Area/2020/Extraction">000289</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Management of adults and children undergoing chimeric antigen receptor T-cell therapy: best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE)</title><author><name sortKey="Yakoub Agha, Ibrahim" sort="Yakoub Agha, Ibrahim" uniqKey="Yakoub Agha I" first="Ibrahim" last="Yakoub-Agha">Ibrahim Yakoub-Agha</name><affiliation wicri:level="3"><nlm:aff id="af1-1050297">CHU de Lille, LIRIC, INSERM U995, Université de Lille, Lille, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU de Lille, LIRIC, INSERM U995, Université de Lille, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Chabannon, Christian" sort="Chabannon, Christian" uniqKey="Chabannon C" first="Christian" last="Chabannon">Christian Chabannon</name><affiliation wicri:level="3"><nlm:aff id="af2-1050297">Institut Paoli-Calmettes & Module Biothérapies, INSERM CBT-1409, Centre d’Investigations Cliniques de Marseille, Marseille, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut Paoli-Calmettes & Module Biothérapies, INSERM CBT-1409, Centre d’Investigations Cliniques de Marseille, Marseille</wicri:regionArea><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Bader, Peter" sort="Bader, Peter" uniqKey="Bader P" first="Peter" last="Bader">Peter Bader</name><affiliation wicri:level="3"><nlm:aff id="af3-1050297">Clinic for Children and Adolescents, University Children’s Hospital, Frankfurt, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Clinic for Children and Adolescents, University Children’s Hospital, Frankfurt</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Basak, Grzegorz W" sort="Basak, Grzegorz W" uniqKey="Basak G" first="Grzegorz W." last="Basak">Grzegorz W. Basak</name><affiliation wicri:level="1"><nlm:aff id="af4-1050297">Department of Hematology, Oncology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland</nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Hematology, Oncology and Internal Medicine, Medical University of Warsaw, Warsaw</wicri:regionArea><wicri:noRegion>Warsaw</wicri:noRegion></affiliation></author><author><name sortKey="Bonig, Halvard" sort="Bonig, Halvard" uniqKey="Bonig H" first="Halvard" last="Bonig">Halvard Bonig</name><affiliation wicri:level="3"><nlm:aff id="af5-1050297">Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Service, Frankfurt, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Transfusion Medicine and Immunohematology of Goethe University and German Red Cross Blood Service, Frankfurt</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Ciceri, Fabio" sort="Ciceri, Fabio" uniqKey="Ciceri F" first="Fabio" last="Ciceri">Fabio Ciceri</name><affiliation wicri:level="3"><nlm:aff id="af6-1050297">Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Università Vita-Salute San Raffaele, IRCCS Ospedale San Raffaele, Milan</wicri:regionArea><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Corbacioglu, Selim" sort="Corbacioglu, Selim" uniqKey="Corbacioglu S" first="Selim" last="Corbacioglu">Selim Corbacioglu</name><affiliation wicri:level="1"><nlm:aff id="af7-1050297">Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital of Regensburg, Regensburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital of Regensburg, Regensburg</wicri:regionArea><wicri:noRegion>Regensburg</wicri:noRegion><wicri:noRegion>Regensburg</wicri:noRegion><wicri:noRegion>Regensburg</wicri:noRegion></affiliation></author><author><name sortKey="Duarte, Rafael F" sort="Duarte, Rafael F" uniqKey="Duarte R" first="Rafael F." last="Duarte">Rafael F. Duarte</name><affiliation wicri:level="3"><nlm:aff id="af8-1050297">Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Universitario Puerta de Hierro Majadahonda, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><affiliation wicri:level="3"><nlm:aff id="af9-1050297">Medizinische Klinikund Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medizinische Klinikund Poliklinik II, Universitätsklinikum Würzburg, Würzburg</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Hudecek, Michael" sort="Hudecek, Michael" uniqKey="Hudecek M" first="Michael" last="Hudecek">Michael Hudecek</name><affiliation wicri:level="3"><nlm:aff id="af9-1050297">Medizinische Klinikund Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Medizinische Klinikund Poliklinik II, Universitätsklinikum Würzburg, Würzburg</wicri:regionArea><placeName><region type="land" nuts="1">Bavière</region><region type="district" nuts="2">District de Basse-Franconie</region><settlement type="city">Wurtzbourg</settlement></placeName></affiliation></author><author><name sortKey="Kersten, Marie Jose" sort="Kersten, Marie Jose" uniqKey="Kersten M" first="Marie José" last="Kersten">Marie José Kersten</name><affiliation wicri:level="4"><nlm:aff id="af10-1050297">Department of Hematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam and LYMMCARE, Amsterdam, the Netherlands</nlm:aff><country xml:lang="fr" wicri:curation="lc">Pays-Bas</country><wicri:regionArea>Department of Hematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam and LYMMCARE, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName><orgName type="university">Université d'Amsterdam</orgName></affiliation></author><author><name sortKey="Kohl, Ulrike" sort="Kohl, Ulrike" uniqKey="Kohl U" first="Ulrike" last="Köhl">Ulrike Köhl</name><affiliation wicri:level="3"><nlm:aff id="af11-1050297">Fraunhofer Institute for Cellular Therapeutics and Immunology (IZI) and Institute of Clinical Immunology, University of Leipzig, Leipzig as well as Institute for Cellular Therapeutics, Hannover Medical School, Hannover, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Fraunhofer Institute for Cellular Therapeutics and Immunology (IZI) and Institute of Clinical Immunology, University of Leipzig, Leipzig as well as Institute for Cellular Therapeutics, Hannover Medical School, Hannover</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation></author><author><name sortKey="Kuball, Jurgen" sort="Kuball, Jurgen" uniqKey="Kuball J" first="Jürgen" last="Kuball">Jürgen Kuball</name><affiliation wicri:level="3"><nlm:aff id="af12-1050297">Department of Hematology and Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht, the Netherlands</nlm:aff><country xml:lang="fr" wicri:curation="lc">Pays-Bas</country><wicri:regionArea>Department of Hematology and Laboratory of Translational Immunology, University Medical Center Utrecht, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Mielke, Stephan" sort="Mielke, Stephan" uniqKey="Mielke S" first="Stephan" last="Mielke">Stephan Mielke</name><affiliation wicri:level="3"><nlm:aff id="af13-1050297">Department of Laboratory Medicine/Department of Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska Institutet and University Hospital, Stockholm, Sweden</nlm:aff><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Laboratory Medicine/Department of Cell Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska Institutet and University Hospital, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Mohty, Mohamad" sort="Mohty, Mohamad" uniqKey="Mohty M" first="Mohamad" last="Mohty">Mohamad Mohty</name><affiliation wicri:level="3"><nlm:aff id="af14-1050297">Hôpital Saint-Antoine, AP-HP, Sorbonne Université, INSERM UMRS 938, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Saint-Antoine, AP-HP, Sorbonne Université, INSERM UMRS 938, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Murray, John" sort="Murray, John" uniqKey="Murray J" first="John" last="Murray">John Murray</name><affiliation wicri:level="3"><nlm:aff id="af15-1050297">Christie Hospital NHS Trust, Manchester, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Christie Hospital NHS Trust, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation></author><author><name sortKey="Nagler, Arnon" sort="Nagler, Arnon" uniqKey="Nagler A" first="Arnon" last="Nagler">Arnon Nagler</name><affiliation wicri:level="1"><nlm:aff id="af16-1050297">The Chaim Sheba Medical Center, Tel-Hashomer, Affiliated with the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel</nlm:aff><country xml:lang="fr">Israël</country><wicri:regionArea>The Chaim Sheba Medical Center, Tel-Hashomer, Affiliated with the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv</wicri:regionArea><wicri:noRegion>Tel-Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Robinson, Stephen" sort="Robinson, Stephen" uniqKey="Robinson S" first="Stephen" last="Robinson">Stephen Robinson</name><affiliation wicri:level="1"><nlm:aff id="af17-1050297">University Hospitals Bristol NHS Foundation Trust, Bristol, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University Hospitals Bristol NHS Foundation Trust, Bristol</wicri:regionArea><wicri:noRegion>Bristol</wicri:noRegion></affiliation></author><author><name sortKey="Saccardi, Riccardo" sort="Saccardi, Riccardo" uniqKey="Saccardi R" first="Riccardo" last="Saccardi">Riccardo Saccardi</name><affiliation wicri:level="1"><nlm:aff id="af18-1050297">Hematology Department, Careggi University Hospital, Florence, Italy</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Hematology Department, Careggi University Hospital, Florence</wicri:regionArea><wicri:noRegion>Florence</wicri:noRegion></affiliation></author><author><name sortKey="Sanchez Guijo, Fermin" sort="Sanchez Guijo, Fermin" uniqKey="Sanchez Guijo F" first="Fermin" last="Sanchez-Guijo">Fermin Sanchez-Guijo</name><affiliation wicri:level="1"><nlm:aff id="af19-1050297">IBSAL-Hospital Universitario de Salamanca, CIC, Universidad de Salamanca, Salamanca, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>IBSAL-Hospital Universitario de Salamanca, CIC, Universidad de Salamanca, Salamanca</wicri:regionArea><wicri:noRegion>Salamanca</wicri:noRegion></affiliation></author><author><name sortKey="Snowden, John A" sort="Snowden, John A" uniqKey="Snowden J" first="John A." last="Snowden">John A. Snowden</name><affiliation wicri:level="1"><nlm:aff id="af20-1050297">Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield</wicri:regionArea><wicri:noRegion>Sheffield</wicri:noRegion></affiliation></author><author><name sortKey="Srour, Micha" sort="Srour, Micha" uniqKey="Srour M" first="Micha" last="Srour">Micha Srour</name><affiliation wicri:level="3"><nlm:aff id="af21-1050297">Service des Maladies du Sang, CHU de Lille, Lille, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Service des Maladies du Sang, CHU de Lille, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Styczynski, Jan" sort="Styczynski, Jan" uniqKey="Styczynski J" first="Jan" last="Styczynski">Jan Styczynski</name><affiliation wicri:level="1"><nlm:aff id="af22-1050297">Department of Pediatric Hematology and Oncology, Collegium Medicum, Nicolaus Copernicus University Torun, Bydgoszcz, Poland</nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea>Department of Pediatric Hematology and Oncology, Collegium Medicum, Nicolaus Copernicus University Torun, Bydgoszcz</wicri:regionArea><wicri:noRegion>Bydgoszcz</wicri:noRegion></affiliation></author><author><name sortKey="Urbano Ispizua, Alvaro" sort="Urbano Ispizua, Alvaro" uniqKey="Urbano Ispizua A" first="Alvaro" last="Urbano-Ispizua">Alvaro Urbano-Ispizua</name><affiliation wicri:level="3"><nlm:aff id="af23-1050297">Department of Hematology, ICMHO, Hospital Clínic de Barcelona, Barcelona, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Hematology, ICMHO, Hospital Clínic de Barcelona, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Hayden, Patrick J" sort="Hayden, Patrick J" uniqKey="Hayden P" first="Patrick J." last="Hayden">Patrick J. Hayden</name><affiliation wicri:level="1"><nlm:aff id="af24-1050297">Department. of Hematology, Trinity College Dublin, St. James’s Hospital, Dublin, Ireland</nlm:aff><country xml:lang="fr">Irlande (pays)</country><wicri:regionArea>Department. of Hematology, Trinity College Dublin, St. James’s Hospital, Dublin</wicri:regionArea><wicri:noRegion>Dublin</wicri:noRegion></affiliation></author><author><name sortKey="Kroger, Nicolaus" sort="Kroger, Nicolaus" uniqKey="Kroger N" first="Nicolaus" last="Kröger">Nicolaus Kröger</name><affiliation wicri:level="3"><nlm:aff id="af25-1050297">Department of Stem Cell Transplantation, University Medical Center Hamburg, Hamburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Stem Cell Transplantation, University Medical Center Hamburg, Hamburg</wicri:regionArea><placeName><settlement type="city">Hambourg</settlement><region type="land" nuts="2">Hambourg</region></placeName></affiliation></author></analytic><series><title level="j">Haematologica</title><idno type="ISSN">0390-6078</idno><idno type="eISSN">1592-8721</idno><imprint><date when="2020">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Chimeric antigen receptor (CAR) T cells are a novel class of anti-cancer therapy in which autologous or allogeneic T cells are engineered to express a CAR targeting a membrane antigen. In Europe, tisagenlecleucel (Kymriah™) is approved for the treatment of refractory/relapsed acute lymphoblastic leukemia in children and young adults as well as relapsed/refractory diffuse large B-cell lymphoma, while axicabtagene ciloleucel (Yescarta™) 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 CAR 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 support for patients, long-term follow-up, post-authorization safety surveillance, and regulatory issues. These recommendations are not prescriptive and are intended as guidance in the use of this novel therapeutic class.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Kuwana, Y" uniqKey="Kuwana Y">Y Kuwana</name></author><author><name sortKey="Asakura, Y" uniqKey="Asakura Y">Y Asakura</name></author><author><name sortKey="Utsunomiya, N" uniqKey="Utsunomiya N">N Utsunomiya</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gross, G" uniqKey="Gross G">G Gross</name></author><author><name sortKey="Waks, T" uniqKey="Waks T">T Waks</name></author><author><name sortKey="Eshhar, Z" uniqKey="Eshhar Z">Z Eshhar</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Quesnel, B" uniqKey="Quesnel B">B Quesnel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sadelain, M" uniqKey="Sadelain M">M Sadelain</name></author><author><name sortKey="Brentjens, 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Snowden</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Espagne</li><li>France</li><li>Irlande (pays)</li><li>Israël</li><li>Italie</li><li>Pays-Bas</li><li>Pologne</li><li>Royaume-Uni</li><li>Suède</li></country><region><li>Angleterre</li><li>Basse-Saxe</li><li>Bavière</li><li>Catalogne</li><li>Communauté de Madrid</li><li>District de Basse-Franconie</li><li>District de Darmstadt</li><li>Grand Manchester</li><li>Hambourg</li><li>Hauts-de-France</li><li>Hesse (Land)</li><li>Hollande-Septentrionale</li><li>Lombardie</li><li>Nord-Pas-de-Calais</li><li>Provence-Alpes-Côte d'Azur</li><li>Svealand</li><li>Utrecht (province)</li><li>Île-de-France</li></region><settlement><li>Amsterdam</li><li>Barcelone</li><li>Francfort-sur-le-Main</li><li>Hambourg</li><li>Hanovre</li><li>Lille</li><li>Madrid</li><li>Manchester</li><li>Marseille</li><li>Milan</li><li>Paris</li><li>Stockholm</li><li>Utrecht</li><li>Wurtzbourg</li></settlement><orgName><li>Université d'Amsterdam</li></orgName></list><tree><country name="France"><region name="Hauts-de-France"><name sortKey="Yakoub Agha, Ibrahim" sort="Yakoub Agha, Ibrahim" uniqKey="Yakoub Agha I" first="Ibrahim" last="Yakoub-Agha">Ibrahim Yakoub-Agha</name></region><name sortKey="Chabannon, Christian" sort="Chabannon, Christian" uniqKey="Chabannon C" first="Christian" last="Chabannon">Christian Chabannon</name><name sortKey="Mohty, Mohamad" sort="Mohty, Mohamad" uniqKey="Mohty M" first="Mohamad" last="Mohty">Mohamad Mohty</name><name sortKey="Srour, Micha" sort="Srour, Micha" uniqKey="Srour M" first="Micha" last="Srour">Micha Srour</name></country><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Bader, Peter" sort="Bader, Peter" uniqKey="Bader P" first="Peter" last="Bader">Peter Bader</name></region><name sortKey="Bonig, Halvard" sort="Bonig, Halvard" uniqKey="Bonig H" first="Halvard" last="Bonig">Halvard Bonig</name><name sortKey="Corbacioglu, Selim" sort="Corbacioglu, Selim" uniqKey="Corbacioglu S" first="Selim" last="Corbacioglu">Selim Corbacioglu</name><name sortKey="Einsele, Hermann" sort="Einsele, Hermann" uniqKey="Einsele H" first="Hermann" last="Einsele">Hermann Einsele</name><name sortKey="Hudecek, Michael" sort="Hudecek, Michael" uniqKey="Hudecek M" first="Michael" last="Hudecek">Michael Hudecek</name><name sortKey="Kohl, Ulrike" sort="Kohl, Ulrike" uniqKey="Kohl U" first="Ulrike" last="Köhl">Ulrike Köhl</name><name sortKey="Kroger, Nicolaus" sort="Kroger, Nicolaus" uniqKey="Kroger N" first="Nicolaus" last="Kröger">Nicolaus Kröger</name></country><country name="Pologne"><noRegion><name sortKey="Basak, Grzegorz W" sort="Basak, Grzegorz W" uniqKey="Basak G" first="Grzegorz W." last="Basak">Grzegorz W. Basak</name></noRegion><name sortKey="Styczynski, Jan" sort="Styczynski, Jan" uniqKey="Styczynski J" first="Jan" last="Styczynski">Jan Styczynski</name></country><country name="Italie"><region name="Lombardie"><name sortKey="Ciceri, Fabio" sort="Ciceri, Fabio" uniqKey="Ciceri F" first="Fabio" last="Ciceri">Fabio Ciceri</name></region><name sortKey="Saccardi, Riccardo" sort="Saccardi, Riccardo" uniqKey="Saccardi R" first="Riccardo" last="Saccardi">Riccardo Saccardi</name></country><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Duarte, Rafael F" sort="Duarte, Rafael F" uniqKey="Duarte R" first="Rafael F." last="Duarte">Rafael F. Duarte</name></region><name sortKey="Sanchez Guijo, Fermin" sort="Sanchez Guijo, Fermin" uniqKey="Sanchez Guijo F" first="Fermin" last="Sanchez-Guijo">Fermin Sanchez-Guijo</name><name sortKey="Urbano Ispizua, Alvaro" sort="Urbano Ispizua, Alvaro" uniqKey="Urbano Ispizua A" first="Alvaro" last="Urbano-Ispizua">Alvaro Urbano-Ispizua</name></country><country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Kersten, Marie Jose" sort="Kersten, Marie Jose" uniqKey="Kersten M" first="Marie José" last="Kersten">Marie José Kersten</name></region><name sortKey="Kuball, Jurgen" sort="Kuball, Jurgen" uniqKey="Kuball J" first="Jürgen" last="Kuball">Jürgen Kuball</name></country><country name="Suède"><region name="Svealand"><name sortKey="Mielke, Stephan" sort="Mielke, Stephan" uniqKey="Mielke S" first="Stephan" last="Mielke">Stephan Mielke</name></region></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Murray, John" sort="Murray, John" uniqKey="Murray J" first="John" last="Murray">John Murray</name></region><name sortKey="Robinson, Stephen" sort="Robinson, Stephen" uniqKey="Robinson S" first="Stephen" last="Robinson">Stephen Robinson</name><name sortKey="Snowden, John A" sort="Snowden, John A" uniqKey="Snowden J" first="John A." last="Snowden">John A. Snowden</name></country><country name="Israël"><noRegion><name sortKey="Nagler, Arnon" sort="Nagler, Arnon" uniqKey="Nagler A" first="Arnon" last="Nagler">Arnon Nagler</name></noRegion></country><country name="Irlande (pays)"><noRegion><name sortKey="Hayden, Patrick J" sort="Hayden, Patrick J" uniqKey="Hayden P" first="Patrick J." last="Hayden">Patrick J. Hayden</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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