eligibility_summary
Ph− B‑ALL after allo‑HSCT: CR1 with high‑risk per NCCN, failure to achieve CR after induction, pre‑HSCT MRD+, or ≥CR2, ≥3 months post‑transplant, engrafted (ANC ≥0.5×10^9/L, platelets >20×10^9/L), MRD‑negative at entry, ECOG 0–2, Tbili ≤3×ULN, ALT/AST ≤5×ULN, CrCl ≥30 mL/min, consent. Exclude: other malignancy, uncontrolled infection/bleeding, LVEF <50%/NYHA III–IV, MRD+, active GVHD needing steroids, pregnancy/lactation, or investigator‑judged unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm maintenance after allo-HSCT in Ph− B-ALL (MRD−). 4 cycles over ~1 year: cycles 1 & 3 decitabine, cycles 2 & 4 venetoclax + blinatumomab. Drugs/mechanisms: Decitabine—DNA methyltransferase (DNMT) inhibitor hypomethylating nucleoside analog (epigenetic therapy) that reactivates tumor-suppressor genes and can increase leukemic cell immunogenicity. Venetoclax—oral small-molecule BCL-2 inhibitor (BH3 mimetic) promoting mitochondrial apoptosis. Blinatumomab—bispecific T-cell engager (BiTE) antibody linking CD3 on T cells to CD19 on B-ALL cells to induce T-cell–mediated cytotoxicity. Targets/pathways: CD19+ B-lymphoblasts, T-cell activation via CD3, intrinsic apoptotic pathway via BCL-2, DNA methylation (DNMT). Primary goal: improve 2-year PFS, also assess efficacy/safety.