RT Journal Article T1 Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. A1 Fowler, Nathan Hale A1 Dickinson, Michael A1 Dreyling, Martin A1 Martinez-Lopez, Joaquin A1 Kolstad, Arne A1 Butler, Jason A1 Ghosh, Monalisa A1 Popplewell, Leslie A1 Chavez, Julio C A1 Bachy, Emmanuel A1 Kato, Koji A1 Harigae, Hideo A1 Kersten, Marie José A1 Andreadis, Charalambos A1 Riedell, Peter A A1 Ho, P Joy A1 Pérez-Simón, José Antonio A1 Chen, Andy I A1 Nastoupil, Loretta J A1 von Tresckow, Bastian A1 Ferreri, Andrés José María A1 Teshima, Takanori A1 Patten, Piers E M A1 McGuirk, Joseph P A1 Petzer, Andreas L A1 Offner, Fritz A1 Viardot, Andreas A1 Zinzani, Pier Luigi A1 Malladi, Ram A1 Zia, Aiesha A1 Awasthi, Rakesh A1 Masood, Aisha A1 Anak, Oezlem A1 Schuster, Stephen J A1 Thieblemont, Catherine AB Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor-T cell therapy with clinically meaningful outcomes demonstrated in patients with relapsed/refractory (r/r) B-cell lymphoma. In a previous pilot study of tisagenlecleucel in r/r follicular lymphoma (FL), 71% of patients achieved a complete response (CR). Here we report the primary, prespecified interim analysis of the ELARA phase 2 multinational trial of tisagenlecleucel in adults with r/r FL after two or more treatment lines or who relapsed after autologous stem cell transplant (no. NCT03568461). The primary endpoint was CR rate (CRR). Secondary endpoints included overall response rate (ORR), duration of response, progression-free survival, overall survival, pharmacokinetics and safety. As of 29 March 2021, 97/98 enrolled patients received tisagenlecleucel (median follow-up, 16.59 months; interquartile range, 13.8-20.21). The primary endpoint was met. In the efficacy set (n = 94), CRR was 69.1% (95% confidence interval, 58.8-78.3) and ORR 86.2% (95% confidence interval, 77.5-92.4). Within 8 weeks of infusion, rates of cytokine release syndrome were 48.5% (grade ≥3, 0%), neurological events 37.1% (grade ≥3, 3%) and immune effector cell-associated neurotoxicity syndrome (ICANS) 4.1% (grade ≥3, 1%) in the safety set (n = 97), with no treatment-related deaths. Tisagenlecleucel is safe and effective in extensively pretreated r/r FL, including in high-risk patients. YR 2021 FD 2021-12-17 LK http://hdl.handle.net/10668/19572 UL http://hdl.handle.net/10668/19572 LA en DS RISalud RD Apr 11, 2025