Subcutaneous blinatumomab in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: post-hoc safety and activity analysis from a multicentre, single-arm, phase 1/2 trial

The Lancet Haematology Pub Date : 2025-06-15 DOI:10.1016/s2352-3026(25)00144-9

Prof Elias Jabbour MD, Federico Lussana MD, Pilar Martínez-Sánchez MD, Anna Torrent MD, José J Rifón MD, Vaibhav Agrawal MD, Mar Tormo MD, Ryan D Cassaday MD, Thomas Cluzeau MD, Françoise Huguet MD, Cristina Papayannidis MD, Jesús M Hernández-Rivas MD, Anita Rijneveld MD, Shaun Fleming MD, Vladan Vucinic MD, Boris Böll MD, Takayuki Ikezoe MD, Maher Abdul-Hay MD, Mary L Savoie MD, Andre C Schuh MD, Celine Berthon MD, Stefan Schwartz MD, Sabina Chiaretti MD, Junichiro Yuda MD, Takuya Miyazaki MD, José González-Campos MD, Yuqi Chen PhD, Hansen Wong PhD, Jessica Choudhry PharmD, Gerhard Zugmaier MD, Erin Guest MD, Paul Gordon MD, Prof Hagop Kantarjian MD

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Abstract

Two doses of subcutaneous blinatumomab in patients with relapsed or refractory B-cell acute lymphoblastic leukaemia were identified as preliminary recommended phase 2 doses, based on the dose-escalation phase of this multicentre single-arm, phase 1/2 trial. Here, we aim to further study the safety, activity, and pharmacokinetics of these doses in all participants who have received them, including those treated in the completed phase 1b expansion part of the study.

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皮下blinatumumab治疗复发或难治性b细胞急性淋巴细胞白血病成人：一项多中心、单臂、1/2期试验的事后安全性和活性分析

根据这项多中心单臂1/2期试验的剂量递增阶段，复发或难治性b细胞急性淋巴细胞白血病患者皮下blinatumumab的两个剂量被确定为初步推荐的2期剂量。在这里，我们的目标是进一步研究这些剂量在所有接受过它们的参与者中的安全性、活性和药代动力学，包括那些在完成的1b期扩展部分研究中治疗的参与者。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The Lancet Haematology

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