The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:
• If the flow cytometric MRD negative (\<0.01%) rate and the NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol).
Participants will:
* Take 14 days full dose Blinatumomab; * With bone marrow evaluated before and after Blinatumomab treatment.
Age older than 1 month to younger than 18 years.
Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
Immunophenotyping: acute B-lymphoblastic leukemia;
Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee
sIgM+;
ALL evolved from chronic myeloid leukemia (CML);
Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
Other secondary leukemias;
Single group
Blinatumomab
DrugRecruited patients will receive Blinatumomab since day 29 of induction for 14 days.
The flow cytometric MRD
The flow cytometric MRD negative (\<0.01%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
The NGS- MRD
The NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
5-year EFS
The 5-year EFS of study group was significantly higher than that of the control group.
Adverse events
Comparison of adverse events in study and control groups
Healthcare costs
Comparison of healthcare costs in study and control groups
Effects of Blinatumomab on immune function
Immune cell subgroup, T-cell activation, depletion, and cytokine releasing will be studied before Blinatumomab and day 7 and day 14 during Blinatumomab, and 1 week after Blinatumomab discontinuation.
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Fujian Maternity and Child Health Hospital
Collaborator
Zhangzhou Affiliated Hospital of Fujian Medical University
Collaborator
Guizhou Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Dalian Women and Children's Medical Center
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Hunan Provincial People's Hospital
Collaborator
Ningbo Women & Children's Hospital
Collaborator
Anhui Provincial Children's Hospital
Collaborator
Jiangxi Province Children's Hospital
Collaborator
Yuying Children's Hospital of Wenzhou Medical University
Collaborator
