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OncoMatch/Clinical Trials/NCT06607419

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

Is NCT06607419 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies Blinatumomab for b-cell lymphoblastic leukemia.

Phase 2/3RecruitingShanghai Jiao Tong University School of MedicineNCT06607419Data as of May 2026

Treatment: BlinatumomabThe 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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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Disease stage

Excluded: Stage INITIAL DIAGNOSIS OF HIGH RISK

Initial diagnosis of high risk [excluded]

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: glucocorticoid

Treated with glucocorticoids for ≥14 days within one month before enrollment

Cannot have received: ABL kinase inhibitor

ABL kinase inhibitors for > 7 days within one month before enrollment

Cannot have received: chemotherapy

Exception: except for emergency radiotherapy to relieve airway compression

any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)

Cannot have received: radiotherapy

Exception: except for emergency radiotherapy to relieve airway compression

any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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