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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.
Anhui Provincial Children's Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGFujian Children's Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGShanghai Children's Medical center
Shanghai, Shanghai Municipality, China
RECRUITINGNingbo Women and Children's Hospital
Ningbo, Zhejiang, China
RECRUITINGThe 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)
Time frame: From the date of Blinatumomab completion to one week after its treatment course
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)
Time frame: From the date of Blinatumomab completion to one week after its treatment course
5-year EFS
The 5-year EFS of study group was significantly higher than that of the control group.
Time frame: 5 years since the last recruited patient completed Blinatumomab.
Adverse events
Comparison of adverse events in study and control groups
Time frame: From day 19 of induction therapy until the start of the second high-dose methotrexate regimen.
Healthcare costs
Comparison of healthcare costs in study and control groups
Time frame: Six-month since window phase
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