eligibility_summary
Inclusion: CD19+ B‑ALL (Ph−/Ph+), ≥14 yrs, poor‑risk cytogenetics, R/R ALL (no CR/CRi after induction, relapse >5% blasts or extramedullary), or MRD+ pre‑HSCT (flow >0.01% or molecular+), NGS‑IGH clone, MRD relapse by NGS (≥10^-6) with <5% marrow blasts at 3–6 mo post HSCT, ECOG ≤2, adequate organs, HIV/HBsAg/HCV−, negative pregnancy test, consent. Exclusion: CNS/extramedullary disease post‑TX/other cancers, major CNS disease, active infection/GVHD, allergy, other trial <4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
This single-arm study in NGS‑MRD–relapsed B‑ALL after auto/allo HSCT tests blinatumomab ± a TKI (for Ph+ disease). Blinatumomab is a bispecific T‑cell engager (BiTE) antibody construct that binds CD19 on B‑ALL blasts and CD3 on T cells, redirecting T‑cell cytotoxicity against CD19+ leukemic cells. In Ph+ B‑ALL, small‑molecule TKIs targeting the BCR‑ABL tyrosine kinase are added to inhibit leukemic signaling and proliferation. Targets: CD19+ B‑lymphoblasts, T‑cell activation via CD3, BCR‑ABL kinase pathway in Ph+ disease. Dexamethasone is used as premedication.