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 Jose
A1 Andreadis, Charalambos
A1 Riedell, Peter A.
A1 Ho, P. Joy
A1 Perez-Simon, Jose Antonio
A1 Chen, Andy, I
A1 Nastoupil, Loretta J.
A1 von-Tresckow, Bastian
A1 Ferreri, Andres Jose Maria
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
K1 Cellular kinetics
K1 Rituximab
K1 Idelalisib
K1 Inhibition
K1 Management
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 .
PB Nature portfolio
SN 1078-8956
YR 2022
FD 2022-02
LK https://hdl.handle.net/10668/27620
UL https://hdl.handle.net/10668/27620
LA en
NO Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, Kolstad A, Butler J, et al.  Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022 Feb;28(2):325-332.
DS RISalud
RD Apr 25, 2025