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Phase 1/2 multicenter trial of acalabrutinib in Chinese patients with relapsed/refractory mantle cell lymphoma.
Song, Yuqin; Li, Jianyong; Zhou, Keshu; Ke, Xiaoyan; Cai, Zhen; Zhang, Huilai; Yao, Tingting; Xia, Zhen; Wang, Yiqiu; Lai, Peiqiong; Liu, Xiaofeng; Zhu, Jun.
Afiliação
  • Song Y; Department of Lymphoma, Peking University Cancer Hospital & Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing, China.
  • Li J; Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
  • Zhou K; Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
  • Ke X; Department of Hematology, Peking University Third Hospital, Beijing, China.
  • Cai Z; Department of Hematology, the First Affiliated Hospital of Medical College, Zhejiang University, Hangzhou, China.
  • Zhang H; Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
  • Yao T; AstraZeneca, Shanghai, China.
  • Xia Z; AstraZeneca, Shanghai, China.
  • Wang Y; AstraZeneca, Shanghai, China.
  • Lai P; AstraZeneca, Shanghai, China.
  • Liu X; AstraZeneca, Shanghai, China.
  • Zhu J; Department of Lymphoma, Peking University Cancer Hospital & Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing, China.
Leuk Lymphoma ; 65(5): 647-652, 2024 May.
Article em En | MEDLINE | ID: mdl-38557285
ABSTRACT
Acalabrutinib studies have limited Asian participation. This phase 1/2 study (NCT03932331) assessed acalabrutinib in Chinese patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL). Primary endpoint was blinded independent central review (BICR)-assessed overall response rate (ORR). Overall, 34 patients were enrolled. Most patients were men (88%); median age was 63 years and 59% had ≥3 prior treatments. Median treatment duration was 14 months (range, 1-24). Any-grade adverse events (AEs) and grade ≥3 AEs occurred in 85.3% and 44.1% of patients, respectively. AEs causing treatment discontinuation were aplastic anemia, thrombocytopenia, and gastrointestinal infection (n = 1 each). Fatal AEs occurred in 2 patients (aplastic anemia and multiple organ dysfunction syndrome [n = 1 each]). BICR-assessed ORR was 82.4% (95% confidence interval [CI] 65.5, 93.2); 12 (35.3%) patients achieved complete response. Estimated 12-month OS was 84.5% (95% CI 66.6, 93.3). Acalabrutinib yielded tolerable safety and high response rates in Chinese patients with R/R MCL.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pirazinas / Benzamidas / Linfoma de Célula do Manto Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País como assunto: Asia Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pirazinas / Benzamidas / Linfoma de Célula do Manto Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País como assunto: Asia Idioma: En Ano de publicação: 2024 Tipo de documento: Article