TY - JOUR
T1 - 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)
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.
PY - 2018/12/18
Y1 - 2018/12/18
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.
KW - Chimeric antigen receptor
KW - T-cell
KW - Leukemia
U2 - 10.1016/j.bbmt.2018.12.068
DO - 10.1016/j.bbmt.2018.12.068
M3 - Article
SN - 1083-8791
JO - BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
JF - BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
ER -