Patient-reported quality of life after tisagenlecleucel infusion in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: A global, single-arm, phase 2 trial
The Lancet Oncology Oct 18, 2019
Laetsch TW, Myers GD, Baruchel A, et al. - Given treatment with tisagenlecleucel, a chimeric antigen receptor targeted against the CD19 antigen, among 75 paediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia led to the achievement of overall remission in 61 (81%) patients in the ELIANA trial, researchers assessed pre- and post-treatment patient-reported quality of life. In ELIANA, a target dose of 0·2–5 × 106 transduced viable T cells per kg was delivered via a single intravenous administration to patients weighing 50 kg or less or 0·1–2·5 × 108 transduced viable T cells for patients weighing more than 50 kg. Quality of life was determined in 58 patients aged 8–23 years. For all measures, patient-reported quality-of-life scores showed improvements at month 3 following tisagenlecleucel infusion. As a treatment option for paediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia, the favourable benefit–risk profile of tisagenlecleucel was suggested, along with the activity and safety outcomes of ELIANA.
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