eligibility_summary
Eligible: adults with newly diagnosed CD33-positive AML who have received, are receiving, or are planned to receive Mylotarg in routine care, must provide informed consent (patient or legal representative). Exclude: Mylotarg contraindication (e.g., hypersensitivity) or refusal to allow Pfizer/partners to use personal data.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05189639 (Pfizer) – post‑marketing, non‑interventional surveillance in South Korea for newly diagnosed CD33+ AML. Intervention: Mylotarg (gemtuzumab ozogamicin), an antibody–drug conjugate (ADC). Mechanism: a humanized anti‑CD33 monoclonal antibody targets CD33 on AML blasts, after receptor-mediated internalization, the linker is cleaved intracellularly to release the cytotoxic payload (calicheamicin), which induces DNA double‑strand breaks, leading to apoptosis. Potential immune effector functions (e.g., ADCC/CDC) are minor relative to ADC payload delivery. Targets: CD33 (SIGLEC‑3) on myeloid leukemic blasts/progenitors, downstream effect is DNA damage response/apoptosis pathways. Purpose: assess safety (AEs/SAEs, expected/unexpected ADRs) and effectiveness during routine clinical use.