eligibility_summary
Inclusion: Adults 18–70 with newly diagnosed CD33+ AML, ECOG ≤2, fit for intensive chemo, adequate organ function (EF ≥50%), contraception (women need negative test), prior malignancy ok if no therapy, prior non‑AML HMA ≥14 d, hydroxyurea allowed. Exclusion: prior AML therapy (except hydroxyurea/leukapheresis), APL, CNS leukemia, severe liver disease, active HBV/HCV, allergy to CPX‑351/GO, excess anthracycline, major cardiac disease/MI <6 mo, recent IND, pregnancy/breastfeeding, FLT3 mutation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/1b single-arm trial testing CPX-351 (Vyxeos) plus gemtuzumab ozogamicin (GO) in newly diagnosed AML. CPX-351 is a liposomal fixed-ratio chemotherapy combining daunorubicin (anthracycline, DNA intercalator/topoisomerase II inhibitor) and cytarabine (antimetabolite cytidine analog inhibiting DNA polymerase), optimizing marrow delivery and synergy. GO (Mylotarg) is an anti-CD33 antibody-drug conjugate that binds CD33 on AML blasts, internalizes, and releases calicheamicin (DNA-cleaving enediyne), causing double-strand breaks and apoptosis. Targets: CD33-positive myeloblasts, pathways include DNA replication/repair, topoisomerase II function, and calicheamicin-induced DNA damage. Goal: define safety, MTD, and RP2D (GO dose-escalated, CPX-351 fixed on Days 1,3,5).