Journal article

Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study

Stephen J Schuster, Constantine S Tam, Peter Borchmann, Nina Worel, Joseph P McGuirk, Harald Holte, Edmund K Waller, Samantha Jaglowski, Michael R Bishop, Lloyd E Damon, Stephen Ronan Foley, Jason R Westin, Isabelle Fleury, P Joy Ho, Stephan Mielke, Takanori Teshima, Murali Janakiram, Jing-Mei Hsu, Koji Izutsu, Marie Jose Kersten Show all

LANCET ONCOLOGY | ELSEVIER SCIENCE INC | Published : 2021

Abstract

BACKGROUND: In the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best overall response rate was 52% and the complete response rate was 40% in 93 evaluable adult patients with relapsed or refractory aggressive B-cell lymphomas. We aimed to do a long-term follow-up analysis of the clinical outcomes and correlative analyses of activity and safety in the full adult cohort. METHODS: In this multicentre, open-label, single-arm, phase 2 trial (JULIET) done at 27 treatment sites in ten countries (Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, and the USA), adult patien..

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