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eligibility_summary
Adults 60–75 with AML (WHO 2022): ELN intermediate/high risk, AML-MRC, t-AML, or CBF-AML with KIT D816, or new hypercellular leukemia (WBC ≥10×10^9/L), in CR/CRi after 1–2 inductions, matched related/haplo/mismatched unrelated donor, ECOG 0–2, CrCl ≥60, AST/ALT ≤3×ULN, bilirubin ≤2×ULN, LVEF ≥50%, survival >8 w, consented. Exclude: serious cardiac disease, severe illness/infection, uncontrolled HIV/hepatitis, pregnant/nursing, unable to consent/comply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06571825 tests two post‑remission strategies for elderly AML after first CR: 1) Venetoclax‑based consolidation (intermediate‑dose cytarabine + venetoclax, azacitidine maintenance). 2) Reduced‑intensity allo‑HSCT with FluBu or FluMel conditioning (fludarabine, busulfan or melphalan ± venetoclax, plus antithymocyte globulin), then azacitidine maintenance, donor lymphocyte infusion allowed for MRD. Mechanisms/targets: Venetoclax is a small‑molecule BCL‑2 inhibitor restoring mitochondrial apoptosis in AML blasts/leukemia stem cells. Cytarabine and fludarabine are antimetabolites blocking DNA synthesis, busulfan/melphalan are DNA‑alkylating agents, azacitidine is a hypomethylating DNA‑methyltransferase inhibitor with epigenetic/immunomodulatory effects, ATG is a T‑cell–depleting polyclonal antibody (GVHD prophylaxis). Allo‑HSCT provides graft‑versus‑leukemia via donor T/NK cells targeting residual AML.