eligibility_summary
Eligibility: ≥65, newly diagnosed WHO 2022 AML, previously untreated except 2 cycles azacitidine+venetoclax, ineligible for intensive induction or poor-risk, excludes favorable-risk cytogenetics. No CR/CRi after 2 cycles. ECOG 0–2 (≥75) or 0–3 (65–74), life expectancy ≥12 wks, adequate cardiac/organ function, WBC<25, no TLS. Exclude: APL, prior AML therapy beyond A+V, curative options, CNS disease, uncontrolled comorbidities/infection, recent cancer, HIV, active HBV/HCV, live vaccine <30d, major surgery <4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: NP137, a first-in-class humanized monoclonal antibody that neutralizes Netrin‑1 to restore dependence‑receptor–mediated apoptosis, azacitidine, a hypomethylating nucleoside analog (DNMT inhibitor) that reactivates silenced genes and primes cells for apoptosis, venetoclax, an oral BCL‑2 inhibitor (BH3 mimetic) that triggers mitochondrial apoptosis. Targeted cells/pathways: AML blasts refractory to azacitidine+venetoclax, pathways include the Netrin‑1/dependence‑receptor apoptotic axis, BCL‑2–regulated intrinsic apoptosis, and epigenetic regulation via DNA hypomethylation. Trial: open‑label, single‑arm Phase I/II in France for refractory AML after 2 Aza+Ven cycles, terminated early for low recruitment.