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

RecruitingPhase 2, Phase 3Ages 1 Month - 18 YearsAllShanghai Jiao Tong University School of Medicine
NCT06607419 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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%.
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What it tests

  • Blinatumomab
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Where

4 sites
Anhui Provincial Children's Hospital
Hefei, China
Fujian Children's Hospital
Fuzhou, China
Shanghai Children's Medical center
Shanghai, China
Ningbo Women and Children's Hospital
Ningbo, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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