Spots Global Cancer Trial Database for Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
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Trial Identification
Brief Title: Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Official Title: An Open-label, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Study ID: NCT03476239
Conditions
Study Description
Brief Summary: This study is being done to evaluate the rate of hematological response (complete remission/complete remission with partial hematological recovery \[CR/CRh\*\]) induced by blinatumomab in Chinese adults with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
Detailed Description: This is an open label, single-arm, multicenter phase 3 study to evaluate efficacy and safety of the BiTE (bispecific T cell engager) antibody blinatumomab in Chinese adults with relapsed/refractory B-precursor ALL. The study will consist of a screening period, a treatment period, and a follow-up period. Treatment will consist of up to 5 cycles of blinatumomab. Participants who achieve a bone marrow (BM) response (≤ 5% BM blasts) or CR/CRh\*/CRi within 2 induction cycles of treatment may continue to receive up to 3 additional consolidation cycles of blinatumomab. Thirty days after end of the last dose of protocol-specified therapy, participants will have a safety follow-up visit. If subjects are suitable for allogeneic stem cell transplantation (alloHSCT) after treatment with blinatumomab, they may undergo alloHSCT instead of receiving further consolidation cycles with blinatumomab. Participants will be followed via clinic visit or telephone contact every 3 months after their safety follow-up visit until death has been observed or a maximum of 2 years after start of treatment, whichever occurs first. A planned interim analysis to assess efficacy and safety of blinatumomab was to be based on the interim analysis set (N = 90). The efficacious benefit assessment based on an O'Brien-Fleming alpha spending function (O'Brien and Fleming, 1979) with the critical boundary 42.2% at the interim analysis and 39.2% at the primary analysis in CR/CRh\* rate. If the interim analysis showed statistically efficacious and overall benefit-risk analysis to be promising per the data review team review, then the interim analysis could become the primary analysis of this study. In addition, the study would continue its enrollment until 120 participants had been enrolled and continued their participation in the study to complete protocol-specified procedures. The data cutoff date of 12 April 2019 allowed for the 90th participant enrolled before 21 February 2019 to have had the opportunity to complete 2 cycles of treatment and the safety follow-up visit (if the participant had discontinued treatment after 2 cycles).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University Third Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Chinese People Liberation Army General Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Guangdong Provincial Peoples Hospital, Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiangya Hospital Central South University, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
The First Hospital of Jilin University, Changchun, Jilin, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
The Second Affiliated Hospital of Xi an Jiaotong University, XI An, Shaanxi, China
West China Hospital, Sichuang University, Chengdu, Sichuan, China
Institute of Hematology and Blood Diseases Hospital Peking Union Medical College, Tianjin, Tianjin, China
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, Zhejiang, China
Peking University International Hosipital, Beijing, , China
Anhui Provincial Hospital, Hefei, , China
Huashan Hospital Affiliated to Fudan University, Shanghai, , China
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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