eligibility_summary
Eligibility: 1 month–<18 yrs with B-ALL confirmed by marrow. Must meet risk: D19MRD ≥0.1% (provisional low risk) or ≥0.01% (provisional intermediate risk). Consent required. Exclusions: sIgM+, ALL from CML, Down syndrome/major congenital disease, secondary leukemia, CNS disease, epilepsy/recent convulsions, congenital immunodef/metabolic or heart failure, steroids ≥14d, ABLi >7d (within 1 mo), chemo/radiation (<3 mo), high-risk at dx, D46MRD ≥1%.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm Phase 2/3 trial in newly diagnosed pediatric B-ALL with poor early response. Intervention: blinatumomab, a bispecific T-cell engager (BiTE) antibody (immunotherapy biologic). Mechanism: binds CD19 on B‑lymphoblasts and CD3 on endogenous T cells to create an immune synapse, activate TCR/CD3 signaling, and induce perforin/granzyme-mediated cytotoxic killing, aiming to eradicate minimal residual disease. Targets: CD19+ B‑cell precursor leukemia cells, CD3 on T lymphocytes and downstream T‑cell activation pathways. Regimen: 14 days of full‑dose blinatumomab starting day 29 of induction. Goal: improve MRD-negative rates (flow <0.01%, NGS <10^-4) vs historical control (CCCG‑ALL2020).