Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03476239|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2018
Last Update Posted : October 29, 2019
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 adult subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
The study will consist of a screening period, a treatment period, and a follow-up period.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Blinatumomab||Phase 3|
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 adult subjects 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. Subjects who have achieved 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 (± 3 days) after end of the last dose of protocol-specified therapy, subjects will have a safety follow-up visit.
If subjects are suitable for alloHSCT after treatment with blinatumomab, they may undergo alloHSCT instead of receiving further consolidation cycles with blinatumomab.
Subjects will be followed via clinic visit or telephone contact every 3 months +/- 1 month after their safety follow-up visit until death has been observed or a maximum of 2 years after start of treatment, whichever occurs first
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Evaluate the efficacy and safety of blinatumomab in Chinese subjects 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
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||October 18, 2017|
|Actual Primary Completion Date :||August 21, 2019|
|Estimated Study Completion Date :||April 25, 2021|
Approximately 120 Chinese adult subjects
Blinatumomab is administered as a continuous intravenous infusion (CIVI). A cycle = 6 weeks (4 weeks of blinatumomab treatment, 2-week treatment-free). Treatment will consist of up to 5 cycles of blinatumomab Subjects who have achieved a bone marrow (BM) response or CR/CRh*/CRi within 2 induction cycles of treatment may continue to receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
- Change in rate of hematological response [CR/CRh] induced by blinatumomab [ Time Frame: Within 2 cycles of treatment (6 weeks/cycle) ]
BM smears (slides) at screening and at the end of each treatment cycle (6 weeks/cycle) will be collected for cytomorphology testing.
The degree of BM infiltration defined by the percentage of leukemic blasts in BM will be evaluated by local laboratories as per cytological assessment. In addition, the BM slides will be provided to the designated central laboratories for hematological assessment.
The results of the local laboratory are applicable for inclusion into the study and for the decision if pre-treatment and/or blinatumomab treatment should be administered if the results of the central laboratory are not yet available at the time these decisions are made. For evaluation of baseline and response, the result of the central laboratory will prevail.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476239
|Beijing, Beijing, China, 100191|
|Beijing, Beijing, China, 100730|
|Beijing, Beijing, China, 100853|
|Fuzhou, Fujian, China, 350001|
|Guangzhou, Guangdong, China, 510080|
|Guangzhou, Guangdong, China, 510120|
|Guangzhou, Guangdong, China, 510515|
|Zhengzhou, Henan, China, 450008|
|Wuhan, Hubei, China, 430030|
|Changsha, Hunan, China, 410008|
|Nanjing, Jiangsu, China, 210029|
|Suzhou, Jiangsu, China, 215006|
|Changchun, Jilin, China, 130021|
|Shenyang, Liaoning, China, 110001|
|XI An, Shaanxi, China, 71004|
|Chengdu, Sichuan, China, 610041|
|Tianjin, Tianjin, China, 300020|
|Hangzhou, Zhejiang, China, 310003|
|Hangzhou, Zhejiang, China, 310009|
|Beijing, China, 102206|
|Hefei, China, 230001|
|Shanghai, China, 200040|