eligibility_summary
Adults ≥18 with histologically confirmed relapsed/refractory AML (incl secondary from MDS/CMML/MPN), WBC <10×10^9/L (hydroxyurea allowed pre‑C1 and during C1–2), CrCl ≥50 mL/min, AST/ALT ≤3×ULN, bilirubin ≤3×ULN, ECOG ≤2. Exclude: APL, active CNS leukemia, prior max RT to critical organ, recent strong/mod CYP3A inducers, significant cardiac disease, uncontrolled infection, other cancers <2y (exceptions), psychiatric illness, solid organ transplant, SCT only if no GVHD/off immunosuppression.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II single-arm trial (withdrawn) in relapsed/refractory CD33+ AML evaluating: 1) Lintuzumab-Ac225 (Actimab-A), a radiolabeled anti-CD33 monoclonal antibody (radioimmunotherapy) that delivers Actinium-225 alpha particles to CD33-expressing leukemic cells, causing DNA double-strand breaks and cytotoxicity, 2) Venetoclax, an oral small-molecule BCL-2 inhibitor that restores mitochondrial apoptosis, 3) Azacitidine, a hypomethylating nucleoside analog/DNMT inhibitor that reduces aberrant DNA methylation and has cytotoxic/epigenetic effects. Targets/pathways: CD33+ AML blasts/myeloid progenitors (via antibody-directed alpha radiation), BCL-2 anti-apoptotic signaling (apoptosis induction), and epigenetic dysregulation through DNA methylation pathways. Goal: define MTD of Lintuzumab-Ac225 with venetoclax/azacitidine and assess composite remission rates.