eligibility_summary
Include: B-ALL, 16–65, relapsed or MRD+ pre‑allo‑HSCT, now in CR post‑allo‑HSCT with hematopoietic recovery (ANC ≥0.5×10^9/L×3d no G‑CSF, PLT ≥20×10^9/L×7d no transfusion, Hb ≥80 g/L, plus ANC ≥1.5 & PLT ≥50 within 45 d), KPS>60/ECOG 0–2, >3‑mo survival, no CNS disease, adequate organs, consent, neg pregnancy test/contraception. Exclude: major organ disease, uncontrolled infection, recent trials, PGF, other active cancers, active GVHD, Chidamide allergy, pregnancy/lactation, HIV, active HBV/HCV, long QT, or otherwise unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II, single-arm maintenance after allo-HSCT for R/R B-ALL. Intervention: Blinatumomab, a bispecific T‑cell engager (BiTE) antibody construct given by continuous IV infusion. Mechanism of action: Simultaneously binds CD19 on B‑lineage leukemia cells and CD3 on T cells, forming an immune synapse that activates cytotoxic T cells and redirects them to kill CD19+ blasts via perforin/granzyme pathways, reducing MRD and relapse risk. Targets: CD19-expressing B‑ALL cells, T‑cell receptor/CD3 signaling on effector T cells. Supportive medication: Dexamethasone premedication (glucocorticoid) to blunt cytokine release and neurotoxicity by suppressing inflammatory cytokine pathways. Timing/dose: Initiated 60–90 days post‑transplant, step‑up dosing over days 1–7, repeated every two months up to 1 year. Primary focus: efficacy and safety in preventing post‑transplant recurrence.