PMID- 31723747
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 2572-9241 (Electronic)
IS  - 2572-9241 (Linking)
VI  - 2
IP  - 1
DP  - 2018 Jan-Feb
TI  - Chimeric Antigen Receptor-T Cell Therapy: Practical Considerations for 
      Implementation in Europe.
PG  - e18
LID - 10.1097/HS9.0000000000000018 [doi]
LID - e18
AB  - Chimeric antigen receptor (CAR)-T cell therapy is a new class of cellular 
      immunotherapies that involves ex vivo genetic modification of T cells to 
      incorporate an engineered CAR. After infusion into the patient, the 
      CAR-expressing T cells recognize specific tumor targets and induce an immune 
      response against them. The technology utilized is fundamentally different from 
      previously available cancer treatments. Currently, most CAR-T cell therapies use 
      autologous T cells. Tisagenlecleucel (formerly CTL019) is an anti-CD19 CAR-T cell 
      therapy that was recently approved in the United States for the treatment of 
      pediatric and young adult patients with relapsed/refractory B-cell acute 
      lymphoblastic leukemia (B-ALL). Tisagenlecleucel has shown robust in vivo 
      expansion and long-term persistence, clinically meaningful durable response and 
      remission rates, and overall survival benefit in pediatric and young adult 
      patients with relapsed/refractory B-ALL and in relapsed/refractory diffuse large 
      B-cell lymphoma. Common adverse events (AEs) include cytokine release syndrome, 
      which may require hospitalization and admission to an intensive care unit, 
      neurological toxicities, and B-cell aplasia. These AEs are manageable when 
      treated by an appropriately trained team. Additional research is required to 
      further develop AE management protocols. In this review, we describe regulatory 
      requirements, clinical considerations, and site-level requirements for clinical 
      study implementation of CAR-T cell therapy in Europe. We also provide a case 
      study of the European experience from the first global clinical trial for 
      tisagenlecleucel, which may serve as a useful starting point for investigators 
      and clinicians looking to implement CAR-T cell therapy at their institutions.
CI  - Copyright (c) 2018 the Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the European Hematology Association.
FAU - Buechner, Jochen
AU  - Buechner J
AD  - Department of Pediatric Hematology and Oncology, Oslo University Hospital, Oslo, 
      Norway.
FAU - Kersten, Marie Jose
AU  - Kersten MJ
AD  - Department of Hematology, Academic Medical Center, University of Amsterdam and 
      LYMMCARE (Lymphoma and Myeloma Center Amsterdam), Amsterdam, Netherlands; on 
      behalf of the HOVON/LLPC (Lunenburg Lymphoma Phase I/II Consortium) working 
      group.
FAU - Fuchs, Miriam
AU  - Fuchs M
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Salmon, Florence
AU  - Salmon F
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Jager, Ulrich
AU  - Jager U
AD  - Department of Medicine I, Division of Hematology and Hemostaseology, Medical 
      University of Vienna, Vienna, Austria.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20180202
PL  - United States
TA  - Hemasphere
JT  - HemaSphere
JID - 101740619
PMC - PMC6745952
EDAT- 2018/02/02 00:00
MHDA- 2018/02/02 00:01
PMCR- 2018/02/02
CRDT- 2019/11/15 06:00
PHST- 2017/10/20 00:00 [received]
PHST- 2017/11/08 00:00 [revised]
PHST- 2017/11/09 00:00 [accepted]
PHST- 2019/11/15 06:00 [entrez]
PHST- 2018/02/02 00:00 [pubmed]
PHST- 2018/02/02 00:01 [medline]
PHST- 2018/02/02 00:00 [pmc-release]
AID - HemaSphere-2017-0031 [pii]
AID - 10.1097/HS9.0000000000000018 [doi]
PST - epublish
SO  - Hemasphere. 2018 Feb 2;2(1):e18. doi: 10.1097/HS9.0000000000000018. eCollection 
      2018 Jan-Feb.