eligibility_summary
Adults (≥18) with AML in 1st/2nd remission (CR, CRi, or MLFS) and MRD ≥0.01% plus CD123+ by flow, ECOG 0–2, adequate organ function (albumin ≥3.2 g/dL, bili ≤1.5 mg/dL, AST/ALT/ALP ≤2.5×ULN, CrCl ≥60 mL/min, Cr ≤1.8), consent, women neg pregnancy test, not breastfeeding. Exclude: MRD−, recent AML therapy, cord blood donor, serious comorbidity/limited survival, significant cardiac disease or LVEF <50%, mandatory DAPT, uncontrolled illness, investigator deems unsafe.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial (withdrawn before opening) tests tagraxofusp-erzs ± azacitidine to clear MRD before allo-HCT in AML. Interventions and mechanisms: - Tagraxofusp-erzs (Elzonris, biological immunotoxin/recombinant fusion protein of IL-3 linked to truncated diphtheria toxin). IL-3 binds IL-3 receptor alpha (CD123) on leukemic cells, enabling internalization of the toxin, which ADP-ribosylates elongation factor-2, halting protein synthesis and inducing cell death. - Azacitidine (Vidaza, hypomethylating antimetabolite/DNMT inhibitor). Incorporates into DNA/RNA, inhibits DNA methyltransferases, causes hypomethylation, re-expression of silenced genes, differentiation/apoptosis, and potential immunomodulation. Cells/pathways targeted: CD123+ AML blasts and leukemic stem/progenitor cells, IL-3R/CD123-mediated endocytosis, translation via EF-2, epigenetic DNA methylation pathways to reduce MRD pre-transplant.