Clinical utilization of Chimeric Antigen Receptors 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 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

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    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 languageEnglish
    JournalBIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
    Early online date18 Dec 2018
    DOIs
    Publication statusE-pub ahead of print - 18 Dec 2018

    Keywords

    • Chimeric antigen receptor
    • T-cell
    • Leukemia

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