Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation

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 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:10.1016/j.bbmt.2018.12.068

Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation

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 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

Research output: Contribution to journal › Editorial

70 Scopus citations

Abstract

On August 30, 2017 the US Food and Drug Administration 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, the European Society for Blood and Marrow Transplantation, the International Society of Cell and Gene Therapy, and the Foundation for the Accreditation of Cellular Therapy 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)	e76-e85
Journal	Biology of Blood and Marrow Transplantation
Volume	25
Issue number	3
DOIs	https://doi.org/10.1016/j.bbmt.2018.12.068
State	Published - Mar 2019

Keywords

Chimeric antigen receptor
Leukemia
T cell

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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 in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation. Biology of Blood and Marrow Transplantation, 25(3), e76-e85. https://doi.org/10.1016/j.bbmt.2018.12.068

Kansagra, Ankit J. ; Frey, Noelle V. ; Bar, Merav et al. / Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia : An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation. In: Biology of Blood and Marrow Transplantation. 2019 ; Vol. 25, No. 3. pp. e76-e85.

@article{321203ceace5483b8cda41511d663a0a,

title = "Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation",

abstract = "On August 30, 2017 the US Food and Drug Administration 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, the European Society for Blood and Marrow Transplantation, the International Society of Cell and Gene Therapy, and the Foundation for the Accreditation of Cellular Therapy 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.",

keywords = "Chimeric antigen receptor, Leukemia, T cell",

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 Joshua Hill 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 = "Funding Information: The authors acknowledge the critical review of the manuscript and constructive feedback from the ASBMT Practice Guideline Committee, ASBMT Cellular Therapy Committee, and the Acute Leukemia Working Party & Cell Therapy & Immunobiology Working Party of the EBMT. Financial disclosure: The authors have nothing to disclose. Conflict of interest statement: A.J.K. Scientific Advisory Board–Celgene. N.V.F. Consultant–Novartis, Servier. T.W.L. Consultant–Novartis. C.M.B. Scientific Advisory Boards–Cellectis, Stock/ownership–Mana Therapeutics, Torque and Neximmune. K.K. Scientific Advisory Boards–Kite/Gilead, Novartis, Juno/Celgene, Atara, Takeda; Clinical Research Site–Kite, Iovance, Juno, Atara. C.C. Consultant–Gilead; Research Funding–Gilead, Celgene; Speaker–Terumo BCT, Novartis. M.A.P. Honorarium–Abbvie, Bellicum, Incyte, Merck, Novartis, Nektar Therapeutics, and Takeda; Data Safety Monitoring Board–Servier and Medigene; Scientific Advisory Boards–MolMed and NexImmune; Research Funding–Incyte, Miltenyi Biotec. L.A. Board of director/Scientific Advisory Board–HCLF, Consultant–AstraZeneca. V.B. Research Funding–Gamida Cell, GT Biopharma; Scientific Advisory Board–Novartis, Kite; Travel funding–Amgen. C.B. Research Funding–Intellia Therapeutics; Scientific Advisory Boards–TxCell, MolMed s.p.a.; Travel funding–Miltenyi. S.A.G. Research Funding— Novartis, Servier, Kite; Consultant/Study Steering Committees/Scientific Advisory Boards–Novartis, Adaptimmune, Eureka, TCR2, Juno, GlaxoSmithKline, Cellectis, Vertex, and Roche. J.H. Consultant–Nohla Therapeutics, Inc. and Amplyx; Research Funding– Karius and Shire. S.K. Research funding–Humanigen, Tolero, Lentigen; Patents and Royalites–Novartis. D.M. Scientific Advisory Board–Janssen; Honoraria–Seattle Genetics, Roche/Genentech; Research Funding–Juno Therapeutics, GlaxoSmithKline. M.A.K. Consultant–Pharmacyclics; Speaker–Incyte Corp, Seattle Genetics and Alexion Pharmaceuticals. E.J. Scientific Advisory Boards–Novartis; Speaker–Medison. J.F.D. Ownership/Equity–WUGEN. D.L.P. Research Funding– Novartis; Scientific Advisory Boards–Novartis, Kite; Patent and Royalty payments–Novartis. S.I.G. Research Funding–Novartis; Tmunity Therapeutics; Scientific Advisory Boards–Aileron; Fate Therapeutics; Intellia; Patent and Royalties–Novartis; Ownership/equity–Carisma Therapeutics. M.S. Research Funding–Fate Theapeutics Inc.; Consultant/Board of Director/Scientific Advisory Board/Patents & Royalties/Research Funding–Juno Therapeutics. M.M. Lecture honoraria and Consultant–Novartis, Amgen and Pfizer. S.K.H. Honorarium–Mallinckrodt. Authorship statement: A.K. N.V.F. M.B. and T.W.L. wrote the first draft of the manuscript and are first authors. All authors contributed substantially to the conception, writing, critical review, and final approval of the submitted version of the manuscript. Financial disclosure: See Acknowledgments on page e84. Publisher Copyright: {\textcopyright} 2018 American Society for Blood and Marrow Transplantation",

year = "2019",

month = mar,

doi = "10.1016/j.bbmt.2018.12.068",

language = "English",

volume = "25",

pages = "e76--e85",

journal = "Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation",

issn = "1083-8791",

number = "3",

}

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, J, 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 in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation', Biology of Blood and Marrow Transplantation, vol. 25, no. 3, pp. e76-e85. https://doi.org/10.1016/j.bbmt.2018.12.068

Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia : An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation. / Kansagra, Ankit J.; Frey, Noelle V.; Bar, Merav et al.

In: Biology of Blood and Marrow Transplantation, Vol. 25, No. 3, 03.2019, p. e76-e85.

Research output: Contribution to journal › Editorial

TY - JOUR

T1 - Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia

T2 - An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation

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

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.

N1 - Funding Information: The authors acknowledge the critical review of the manuscript and constructive feedback from the ASBMT Practice Guideline Committee, ASBMT Cellular Therapy Committee, and the Acute Leukemia Working Party & Cell Therapy & Immunobiology Working Party of the EBMT. Financial disclosure: The authors have nothing to disclose. Conflict of interest statement: A.J.K. Scientific Advisory Board–Celgene. N.V.F. Consultant–Novartis, Servier. T.W.L. Consultant–Novartis. C.M.B. Scientific Advisory Boards–Cellectis, Stock/ownership–Mana Therapeutics, Torque and Neximmune. K.K. Scientific Advisory Boards–Kite/Gilead, Novartis, Juno/Celgene, Atara, Takeda; Clinical Research Site–Kite, Iovance, Juno, Atara. C.C. Consultant–Gilead; Research Funding–Gilead, Celgene; Speaker–Terumo BCT, Novartis. M.A.P. Honorarium–Abbvie, Bellicum, Incyte, Merck, Novartis, Nektar Therapeutics, and Takeda; Data Safety Monitoring Board–Servier and Medigene; Scientific Advisory Boards–MolMed and NexImmune; Research Funding–Incyte, Miltenyi Biotec. L.A. Board of director/Scientific Advisory Board–HCLF, Consultant–AstraZeneca. V.B. Research Funding–Gamida Cell, GT Biopharma; Scientific Advisory Board–Novartis, Kite; Travel funding–Amgen. C.B. Research Funding–Intellia Therapeutics; Scientific Advisory Boards–TxCell, MolMed s.p.a.; Travel funding–Miltenyi. S.A.G. Research Funding— Novartis, Servier, Kite; Consultant/Study Steering Committees/Scientific Advisory Boards–Novartis, Adaptimmune, Eureka, TCR2, Juno, GlaxoSmithKline, Cellectis, Vertex, and Roche. J.H. Consultant–Nohla Therapeutics, Inc. and Amplyx; Research Funding– Karius and Shire. S.K. Research funding–Humanigen, Tolero, Lentigen; Patents and Royalites–Novartis. D.M. Scientific Advisory Board–Janssen; Honoraria–Seattle Genetics, Roche/Genentech; Research Funding–Juno Therapeutics, GlaxoSmithKline. M.A.K. Consultant–Pharmacyclics; Speaker–Incyte Corp, Seattle Genetics and Alexion Pharmaceuticals. E.J. Scientific Advisory Boards–Novartis; Speaker–Medison. J.F.D. Ownership/Equity–WUGEN. D.L.P. Research Funding– Novartis; Scientific Advisory Boards–Novartis, Kite; Patent and Royalty payments–Novartis. S.I.G. Research Funding–Novartis; Tmunity Therapeutics; Scientific Advisory Boards–Aileron; Fate Therapeutics; Intellia; Patent and Royalties–Novartis; Ownership/equity–Carisma Therapeutics. M.S. Research Funding–Fate Theapeutics Inc.; Consultant/Board of Director/Scientific Advisory Board/Patents & Royalties/Research Funding–Juno Therapeutics. M.M. Lecture honoraria and Consultant–Novartis, Amgen and Pfizer. S.K.H. Honorarium–Mallinckrodt. Authorship statement: A.K. N.V.F. M.B. and T.W.L. wrote the first draft of the manuscript and are first authors. All authors contributed substantially to the conception, writing, critical review, and final approval of the submitted version of the manuscript. Financial disclosure: See Acknowledgments on page e84. Publisher Copyright: © 2018 American Society for Blood and Marrow Transplantation

PY - 2019/3

Y1 - 2019/3

N2 - On August 30, 2017 the US Food and Drug Administration 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, the European Society for Blood and Marrow Transplantation, the International Society of Cell and Gene Therapy, and the Foundation for the Accreditation of Cellular Therapy 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 US Food and Drug Administration 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, the European Society for Blood and Marrow Transplantation, the International Society of Cell and Gene Therapy, and the Foundation for the Accreditation of Cellular Therapy 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.

KW - Chimeric antigen receptor

KW - Leukemia

KW - T cell

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U2 - 10.1016/j.bbmt.2018.12.068

DO - 10.1016/j.bbmt.2018.12.068

M3 - Editorial

C2 - 30576834

AN - SCOPUS:85060307161

SN - 1083-8791

VL - 25

SP - e76-e85

JO - Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

JF - Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

IS - 3

ER -

Kansagra AJ, Frey NV, Bar M, Laetsch TW, Carpenter PA, Savani BN et al. Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation. Biology of Blood and Marrow Transplantation. 2019 Mar;25(3):e76-e85. doi: 10.1016/j.bbmt.2018.12.068

Clinical Utilization of Chimeric Antigen Receptor T Cells in B Cell Acute Lymphoblastic Leukemia: An Expert Opinion from the European Society for Blood and Marrow Transplantation and the American Society for Blood and Marrow Transplantation

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