VAH vs VA in Newly Diagnosed Elderly AML

Exclusion Criteria

• •Prior treatment with hypomethylating agents for myelodysplastic syndrome (MDS). Prior chemotherapy for AML, except hydroxyurea. Prior CAR-T cell therapy.
• •Prior investigational therapy for AML.
• •Documented history of myeloproliferative neoplasm (MPN).
• •Favorable-risk AML according to 2022 European LeukemiaNet (ELN) criteria.
• •Known active central nervous system (CNS) involvement of AML.
• •Known human immunodeficiency virus (HIV) infection.
• •Active hepatitis B or hepatitis C requiring antiviral therapy. Risk of hepatitis B reactivation (hepatitis B surface antigen positive or hepatitis B core antibody positive without antiviral prophylaxis).
• •History of another malignancy within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated with curative intent.
• •Unstable systemic disease including unstable angina, cerebrovascular accident, or transient ischemic attack within 3 months prior to screening. Myocardial infarction within 3 months prior to screening. Congestive heart failure New York Heart Association class III or IV. Recent pacemaker implantation. Severe liver, kidney, or metabolic disease requiring ongoing treatment. Pulmonary arterial hypertension. Clinically significant or uncontrolled arrhythmias including persistent atrial fibrillation or flutter, symptomatic ventricular arrhythmias, QTc ≥ 470 ms in males or ≥ 480 ms in females, second- or third-degree atrioventricular block without pacemaker, or arrhythmias requiring continuous antiarrhythmic therapy.
• •Malabsorption syndrome or any condition preventing enteral drug administration. Active systemic infection requiring treatment.
• •Significant neurological or psychiatric disorders requiring treatment including epilepsy grade 2 or higher, paralysis, aphasia, recent cerebral infarction, severe traumatic brain injury, dementia, Parkinson's disease, or schizophrenia.
• •Fertile males or females of childbearing potential unwilling to use effective contraception during treatment and for 12 months after completion of treatment.
• •White blood cell count \> 25 × 10⁹/L at screening (hydroxyurea permitted to reduce count to meet eligibility).