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Bone Marrow Transplant. 2019 May 15. doi: 10.1038/s41409-019-0451-2. [Epub ahead of print]

Clinical utilization of Chimeric Antigen Receptor T-cells (CAR-T) in B-cell acute lymphoblastic leukemia (ALL)-an expert opinion from the European Society for Blood and Marrow Transplantation (EBMT) and the American Society for Blood and Marrow Transplantation (ASBMT).

Author information

1
Department of Hematology and Oncology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
2
Cell Therapy and Transplant Program, Abramson Cancer Center and the Division of Hematology and Oncology, University of Pennsylvania, Philadelphia, PA, USA.
3
Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA.
4
Division of Pediatric Hematology-Oncology, Department of Pediatrics, University of Texas Southwestern Medical Center and Children's Health, Dallas, TX, USA.
5
Division of Hematology/Oncology, Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
6
Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital and Texas Children's Hospital, Houston, TX, USA.
7
Center for Cancer and Immunology Research, Children's National Health System, Washington, DC, USA.
8
Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL, USA.
9
Department of Laboratory Medicine and Pathology, Mayo Clinic, Phoenix, AZ, USA.
10
Institut Paoli-Calmettes, Centre de Lutte Contre le Cancer; Centre d'Investigations Cliniques en Biothérapie, Université d'Aix-Marseille, Inserm CBT, 1409, Marseille, France.
11
Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA.
12
Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.
13
Oncology Centre, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
14
Division of Hematology, Ohio State University Wexner Medical Center, Columbus, OH, USA.
15
Stem Cell Transplantation and Cellular Therapy Program, GW Cancer Center, George Washington University, Washington, DC, USA.
16
Division of Hematology/Oncology/Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN, USA.
17
Experimental Hematology Unit, University Vita-Salute San Raffaele and Ospedale San Raffaele, Milano, Italy.
18
Division of Oncology, Department of Medicine, Washington University School of Medicine, St Louis, MO, USA.
19
Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
20
Department of Immunology, Mayo Clinic, Rochester, MN, USA.
21
Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
22
The Chaim Sheba Medical Center, Tel-Hashomer, Affiliated with the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
23
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
24
Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
25
Division of Hematology-Oncology, Mayo Clinic, Jacksonville, FL, USA.
26
Department of Haematological Medicine, King's College, London, UK.
27
Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
28
Bone Marrow Transplantation Program, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.
29
Experimental Transplantation and Immunology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
30
Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA.
31
Center for Cell Engineering and Immunology Program, Sloan Kettering Institute, New York, NY, USA.
32
Department of Immunology, Mayo Clinic, Rochester, MN, USA. litzow.mark@mayo.edu.
33
Hôpital Saint-Antoine, APHP, Sorbonne Universite, INSERM UMRs 938, Paris, France. Mohamed.mohty@inserm.fr.
34
Division of Hematology, Ohio State University Wexner Medical Center, Columbus, OH, USA. hashmi.shahrukh@mayo.edu.
35
Department of Immunology, Mayo Clinic, Rochester, MN, USA. hashmi.shahrukh@mayo.edu.

Abstract

On August 30, 2017, the U.S. Food and Drug Administration (US-FDA) approved tisagenlecleucel (KYMRIAH, Novartis, Basel, Switzerland), a synthetic bioimmune product of anti-CD19 chimeric antigen receptor-T cells (CAR-T), for the treatment of children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). With this new era of personalized cancer immunotherapy, multiple challenges are present ranging from implementation of a CAR-T program to safe delivery of the drug, long-term toxicity monitoring and disease assessments. To address these issues, experts representing the American Society for Blood and Marrow Transplant (ASBMT), the European Group for Blood and Marrow Transplantation (EBMT), the International Society of Cell and Gene Therapy (ISCT), and the Foundation for the Accreditation of Cellular Therapy (FACT), formed a global CAR-T task force to identify and address key questions pertinent for hematologists and transplant physicians regarding the clinical use of anti CD19 CAR-T therapy in patients with B-ALL. This article presents an initial roadmap for navigating common clinical practice scenarios that will become more prevalent now that the first commercially available CAR-T product for B-ALL has been approved.

PMID:
31092900
DOI:
10.1038/s41409-019-0451-2

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