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)

Ankit J. Kansagra; Noelle V. Frey; Merav Bar; Theodore W. Laetsch; Paul A. Carpenter; Bipin N. Savani; Helen E. Heslop; Catherine M. Bollard; Krishna V. Komanduri; Dennis A. Gastineau; Christian Chabannon; Miguel A. Perales; Michael Hudecek; Mahmoud Aljurf; Leslie Andritsos; John A. Barrett; Veronika Bachanova; Chiara Bonini; Armin Ghobadi; Saar I. Gill; Joshua A. Hill; Saad Kenderian; Partow Kebriaei; Arnon Nagler; David Maloney; Hien D. Liu; Nirali N. Shah; Mohamed A. Kharfan-Dabaja; Elizabeth J. Shpall; Ghulam J. Mufti; Laura Johnston; Elad Jacoby; Ali Bazarbachi; John F. DiPersio; Steven Z. Pavletic; David L. Porter; Stephan A. Grupp; Michel Sadelain; Mark R. Litzow; Mohamad Mohty; Shahrukh K. Hashmi

doi:10.1038/s41409-019-0451-2

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)

Ankit J. Kansagra, Noelle V. Frey, Merav Bar, Theodore W. Laetsch, Paul A. Carpenter, Bipin N. Savani, Helen E. Heslop, Catherine M. Bollard, Krishna V. Komanduri, Dennis A. Gastineau, Christian Chabannon, Miguel A. Perales, Michael Hudecek, Mahmoud Aljurf, Leslie Andritsos, John A. Barrett, Veronika Bachanova, Chiara Bonini, Armin Ghobadi, Saar I. GillJoshua A. Hill, Saad Kenderian, Partow Kebriaei, Arnon Nagler, David Maloney, Hien D. Liu, Nirali N. Shah, Mohamed A. Kharfan-Dabaja, Elizabeth J. Shpall, Ghulam J. Mufti, Laura Johnston, Elad Jacoby, Ali Bazarbachi, John F. DiPersio, Steven Z. Pavletic, David L. Porter, Stephan A. Grupp, Michel Sadelain, Mark R. Litzow, Mohamad Mohty, Shahrukh K. Hashmi^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

93 Scopus citations

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.

Original language	English
Pages (from-to)	1868-1880
Number of pages	13
Journal	Bone Marrow Transplantation
Volume	54
Issue number	11
DOIs	https://doi.org/10.1038/s41409-019-0451-2
State	Published - 1 Nov 2019
Externally published	Yes

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Kansagra, A. J., Frey, N. V., Bar, M., Laetsch, T. W., Carpenter, P. A., Savani, B. N., Heslop, H. E., Bollard, C. M., Komanduri, K. V., Gastineau, D. A., Chabannon, C., Perales, M. A., Hudecek, M., Aljurf, M., Andritsos, L., Barrett, J. A., Bachanova, V., Bonini, C., Ghobadi, A., ... Hashmi, S. K. (2019). 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). Bone Marrow Transplantation, 54(11), 1868-1880. https://doi.org/10.1038/s41409-019-0451-2

Kansagra, Ankit J. ; Frey, Noelle V. ; Bar, Merav et al. / 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). In: Bone Marrow Transplantation. 2019 ; Vol. 54, No. 11. pp. 1868-1880.

@article{080d427beac74bef89010587c2e06035,

title = "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)",

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.",

author = "Kansagra, {Ankit J.} and Frey, {Noelle V.} and Merav Bar and Laetsch, {Theodore W.} and Carpenter, {Paul A.} and Savani, {Bipin N.} and Heslop, {Helen E.} and Bollard, {Catherine M.} and Komanduri, {Krishna V.} and Gastineau, {Dennis A.} and Christian Chabannon and Perales, {Miguel A.} and Michael Hudecek and Mahmoud Aljurf and Leslie Andritsos and Barrett, {John A.} and Veronika Bachanova and Chiara Bonini and Armin Ghobadi and Gill, {Saar I.} and Hill, {Joshua A.} and Saad Kenderian and Partow Kebriaei and Arnon Nagler and David Maloney and Liu, {Hien D.} and Shah, {Nirali N.} and Kharfan-Dabaja, {Mohamed A.} and Shpall, {Elizabeth J.} and Mufti, {Ghulam J.} and Laura Johnston and Elad Jacoby and Ali Bazarbachi and DiPersio, {John F.} and Pavletic, {Steven Z.} and Porter, {David L.} and Grupp, {Stephan A.} and Michel Sadelain and Litzow, {Mark R.} and Mohamad Mohty and Hashmi, {Shahrukh K.}",

note = "Publisher Copyright: {\textcopyright} 2019, Springer Nature Limited.",

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day = "1",

doi = "10.1038/s41409-019-0451-2",

language = "אנגלית",

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pages = "1868--1880",

journal = "Bone Marrow Transplantation",

issn = "0268-3369",

publisher = "Springer Nature",

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Kansagra, AJ, Frey, NV, Bar, M, Laetsch, TW, Carpenter, PA, Savani, BN, Heslop, HE, Bollard, CM, Komanduri, KV, Gastineau, DA, Chabannon, C, Perales, MA, Hudecek, M, Aljurf, M, Andritsos, L, Barrett, JA, Bachanova, V, Bonini, C, Ghobadi, A, Gill, SI, Hill, JA, Kenderian, S, Kebriaei, P, Nagler, A, Maloney, D, Liu, HD, Shah, NN, Kharfan-Dabaja, MA, Shpall, EJ, Mufti, GJ, Johnston, L, Jacoby, E, Bazarbachi, A, DiPersio, JF, Pavletic, SZ, Porter, DL, Grupp, SA, Sadelain, M, Litzow, MR, Mohty, M & Hashmi, SK 2019, '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)', Bone Marrow Transplantation, vol. 54, no. 11, pp. 1868-1880. https://doi.org/10.1038/s41409-019-0451-2

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). / Kansagra, Ankit J.; Frey, Noelle V.; Bar, Merav et al.
In: Bone Marrow Transplantation, Vol. 54, No. 11, 01.11.2019, p. 1868-1880.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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)

AU - Kansagra, Ankit J.

AU - Frey, Noelle V.

AU - Bar, Merav

AU - Laetsch, Theodore W.

AU - Carpenter, Paul A.

AU - Savani, Bipin N.

AU - Heslop, Helen E.

AU - Bollard, Catherine M.

AU - Komanduri, Krishna V.

AU - Gastineau, Dennis A.

AU - Chabannon, Christian

AU - Perales, Miguel A.

AU - Hudecek, Michael

AU - Aljurf, Mahmoud

AU - Andritsos, Leslie

AU - Barrett, John A.

AU - Bachanova, Veronika

AU - Bonini, Chiara

AU - Ghobadi, Armin

AU - Gill, Saar I.

AU - Hill, Joshua A.

AU - Kenderian, Saad

AU - Kebriaei, Partow

AU - Nagler, Arnon

AU - Maloney, David

AU - Liu, Hien D.

AU - Shah, Nirali N.

AU - Kharfan-Dabaja, Mohamed A.

AU - Shpall, Elizabeth J.

AU - Mufti, Ghulam J.

AU - Johnston, Laura

AU - Jacoby, Elad

AU - Bazarbachi, Ali

AU - DiPersio, John F.

AU - Pavletic, Steven Z.

AU - Porter, David L.

AU - Grupp, Stephan A.

AU - Sadelain, Michel

AU - Litzow, Mark R.

AU - Mohty, Mohamad

AU - Hashmi, Shahrukh K.

PY - 2019/11/1

Y1 - 2019/11/1

N2 - 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.

AB - 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.

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Kansagra AJ, Frey NV, Bar M, Laetsch TW, Carpenter PA, Savani BN et al. 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). Bone Marrow Transplantation. 2019 Nov 1;54(11):1868-1880. doi: 10.1038/s41409-019-0451-2

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)

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