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Fowler, Nathan Hale; Dickinson, Michael; Dreyling, Martin; Martinez-Lopez, Joaquin; Kolstad, Arne; Butler, Jason; Ghosh, Monalisa; Popplewell, Leslie; Chavez, Julio C; Bachy, Emmanuel; Kato, Koji; Harigae, Hideo; Kersten, Marie José; Andreadis, Charalambos; Riedell, Peter A; Ho, P Joy; Pérez-Simón, José Antonio; Chen, Andy I; Nastoupil, Loretta J; von Tresckow, Bastian; Ferreri, Andrés José María; Teshima, Takanori; Patten, Piers E M; McGuirk, Joseph P; Petzer, Andreas L; Offner, Fritz; Viardot, Andreas; Zinzani, Pier Luigi; Malladi, Ram; Zia, Aiesha; Awasthi, Rakesh; Masood, Aisha; Anak, Oezlem; Schuster, Stephen J; Thieblemont, Catherine
Nature medicine, 02/2022, Letnik: 28, Številka: 2Journal Article
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.
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Dostop do baze podatkov JCR je dovoljen samo uporabnikom iz Slovenije. Vaš trenutni IP-naslov ni na seznamu dovoljenih za dostop, zato je potrebna avtentikacija z ustreznim računom AAI.
Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
Baze podatkov, v katerih je revija indeksirana
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Vir: Osebne bibliografije
in: SICRIS
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