Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia

Summary

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.

Eligibility

Inclusion Criteria:

* Age older than 1 month to younger than 18 years.
* Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
* Immunophenotyping: acute B-lymphoblastic leukemia;
* Meet one of the following situations:

A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;

* Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee

Exclusion Criteria:

* sIgM+;
* ALL evolved from chronic myeloid leukemia (CML);
* Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
* Other secondary leukemias;
* CNS involvement;
* History of epilepsy; or convulsions within the last month;
* Known underlying congenital immunodeficiency or metabolic disease;
* Congenital heart disease with cardiac insufficiency;
* Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);
* Initial diagnosis of high risk;
* D46MRD ≥1%.

Conditions2

Interventions1

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