高级检索
当前位置: 首页 > 详情页

Efficacy and safety blinatumomab in chinese adults with Ph-negative relapsed/refractory B-cell Precursor acute lymphoblastic leukemia: A multicenter open-label single-arm China registrational study

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

单位: [1]Southern Med Univ, Nanfang Hosp, Guangzhou, Peoples R China [2]Henan Canc Hosp, Zhengzhou, Peoples R China [3]Zhejiang Univ, Affiliated Hosp 1, Coll Med, Hangzhou, Peoples R China [4]Sichuan Univ, West China Hosp, Chengdu, Peoples R China [5]Peking Univ Int Hosp, Beijing, Peoples R China [6]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Wuhan, Peoples R China [7]Anhui Prov Hosp, Hefei, Peoples R China [8]China Med Univ, Hosp 1, Shenyang, Peoples R China [9]Cent South Univ, Xiangya Hosp, Changsha, Peoples R China [10]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China [11]First Hosp Jilin Univ, Jilin, Jilin, Peoples R China [12]Fujian Med Univ Union Hosp, Fuzhou, Fujian, Peoples R China [13]Xi An Jiao Tong Univ, Affiliated Hosp 2, Xian, Shaanxi, Peoples R China [14]Guangdong Acad Med Sci, Guangdong Prov Peoples Hosp, Dept Hematol, Guangzhou, Peoples R China [15]Chinese People Liberat Army Gen Hosp, Beijing, Peoples R China [16]Zhejiang Univ, Coll Med, Affiliated Hosp 2, Hangzhou, Zhejiang, Peoples R China [17]Peking Univ Third Hosp, Beijing, Peoples R China [18]Peking Union Med Coll Hosp, Beijing, Peoples R China [19]Soochow Univ, Affiliated Hosp 1, Suzhou, Jiangsu, Peoples R China [20]Fudan Univ, Huashan Hosp, Shanghai, Peoples R China [21]Amgen Inc, Global Biostat Sci, Thousand Oaks, CA 91320 USA [22]Amgen Inc, Global Dev, Thousand Oaks, CA 91320 USA [23]Amgen China, Shanghai, Peoples R China [24]Amgen Res Munich GmbH, Global Dev, Munich, Germany [25]Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, Tianjin, Peoples R China
出处:
ISSN:

关键词: Acute lymphoblastic leukemia relapsed/refractory BiTE (R) molecule blinatumomab Chinese adults

摘要:
Objectives: The prognosis for adults with relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (BCP-ALL) is poor. Blinatumomab is a CD3/CD19-directed BITE (R) (bispecific T-cell engager) molecule approved globally for the treatment of BCP-ALL in adults and children. This multicenter open-label single-arm China registrational study evaluated the safety, efficacy, and pharmacokinetics of blinatumomab in Chinese adults with Philadelphia chromosome-negative (Ph-) R/R BCP-ALL (NCT03476239). Methods: Patients aged >= 18 years were treated with up to 5 cycles of blinatumomab. The primary objective was to evaluate the hematological response rate (complete remission/ complete remission with partial hematological recovery [CR/CRh]) within 2 cycles of blinatumomab. Results: At the interim analysis (April 12, 2019), 90 patients (median age 31.5 years [range: 1874]; 53.3% female; 77.8% with bone marrow blasts >= 50% at study entry) were enrolled at 23 study centers in China and had received blinatumomab. As of data cutoff, 43 patients (47.8%) continued the study. The CR/CRh rate within 2 cycles of blinatumomab was 45.6% (41/90 [CR, 37; CRh, 4]; 95% CI: 35.0-56.4). Median overall survival was 9.2 months (95% CI: 6.5-11.7); median relapse-free survival was 4.3 months (95% CI: 3.2-9.4). Mean serum concentration at steady-state and systemic clearance of blinatumomab in Chinese patients were within the range reported in adults from global clinical trials. No new safety risks were identified in Chinese patients. Conclusions: The efficacy and safety of blinatumomab in these heavily pre-treated Chinese patients with Ph- R/R BCP-ALL is comparable to that for patients within global clinical trials.

基金:
语种:
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2021]版:
大类 | 4 区 医学
小类 | 4 区 血液学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 血液学
JCR分区:
出版当年[2020]版:
Q4 HEMATOLOGY
最新[2023]版:
Q3 HEMATOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者:
第一作者单位: [1]Southern Med Univ, Nanfang Hosp, Guangzhou, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:434 今日访问量:0 总访问量:419 更新日期:2025-05-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)