eligibility_summary
Eligibility: de novo newly diagnosed AML, age ≤18 years (incl. neonates), consent/assent, able to comply. Ri randomization: CD33+ blasts at diagnosis and specific consent. Rc randomization: enrolled in CHIP-AML22, Standard Risk, consent. Key exclusions: prior chemo/RT or therapy-related AML, germline marrow-failure syndromes, Down-syndrome ML, APL, MDS, JMML, drug intolerance, cardiac SF<28%, pregnancy/lactation/inadequate contraception, other trial/therapy, noncompliance, active HBV/HCV/HIV, no consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 open‑label pediatric AML master protocol. Interventions: (a) Consolidation intensity: standard 3 courses (HAM+HA3E+FLA) vs 2 courses (HAM+FLA) to reduce toxicity, (b) Gemtuzumab ozogamicin (GO, anti‑CD33 antibody‑drug conjugate delivering calicheamicin) added to first induction in CD33+ AML, (c) Quizartinib (oral small‑molecule FLT3 tyrosine‑kinase inhibitor) with the first three chemo courses and as post‑SCT continuation in FLT3‑ITD/NPM1wt with MRD, (d) Dexrazoxane (cardioprotective iron‑chelator/topoisomerase II inhibitor) with anthracycline/mitoxantrone courses. Targets/pathways: FLT3 signaling in FLT3‑ITD AML blasts (quizartinib), CD33 antigen on leukemic myeloblasts enabling calicheamicin‑induced DNA breaks (GO), standard intensive chemotherapy acts on DNA synthesis/topoisomerase II in rapidly dividing blasts, dexrazoxane protects cardiomyocytes from anthracycline ROS/topoIIβ injury. Risk stratification uses MRD, KMT2A‑r, RAM phenotype, CBFA2T3::GLIS2.