Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia
Shannon L. Maude, Theodore W. Laetsch, Jochen Buechner · ELIANA trial investigators
Summary
This paper reports the pivotal global phase 2 ELIANA trial of tisagenlecleucel, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia. It demonstrated high rates of durable remission and supported the first FDA approval of a CAR-T cell therapy. The study also characterized the safety profile, including cytokine release syndrome.
Key findings
- Overall remission rate within 3 months was 81%, with all responders negative for minimal residual disease.
- Event-free survival was 73% and overall survival 90% at 6 months in a heavily pretreated population.
- Cytokine release syndrome occurred in 77% of patients and was manageable, defining the key toxicity profile of CD19 CAR-T therapy.
Subjects & keywords
Cite this paper
Shannon L. Maude, Theodore W. Laetsch, & Jochen Buechner [ELIANA trial investigators] (2018). Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. New England Journal of Medicine. https://doi.org/10.1056/NEJMoa1709866
@article{maude2018tisagenlecleucel,
author = {Shannon L. Maude and Theodore W. Laetsch and Jochen Buechner and {ELIANA trial investigators}},
title = {Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia},
journal = {New England Journal of Medicine},
year = {2018},
doi = {10.1056/NEJMoa1709866},
url = {https://doi.org/10.1056/NEJMoa1709866}
}