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
{"title":"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","authors":"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","doi":"10.1016/s2352-3026(25)00144-9","DOIUrl":null,"url":null,"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.","PeriodicalId":501011,"journal":{"name":"The Lancet Haematology","volume":"44 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"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\",\"doi\":\"10.1016/s2352-3026(25)00144-9\",\"DOIUrl\":null,\"url\":null,\"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.\",\"PeriodicalId\":501011,\"journal\":{\"name\":\"The Lancet Haematology\",\"volume\":\"44 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-06-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Lancet Haematology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/s2352-3026(25)00144-9\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Lancet Haematology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/s2352-3026(25)00144-9","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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
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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