VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma

Korábbi kezelés

• Patients with a history or concurrent diagnosis of other malignancies requiring treatment
• Known infection with human immunodeficiency virus (HIV); active hepatitis B or C infection; inactive hepatitis carriers or subjects with low viral titers after receiving non-prohibited antiviral therapy are not excluded
• Subjects who have received strong or moderate CYP3A inducers/inhibitors or strong P-gp inhibitors or related foods within 7 days before starting the study treatment

Más betegség

• Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
• Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
• Patients with a history of severe neurological or psychiatric disorders
• Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
• Patients unable to take oral medications or with malabsorption syndrome

Egyéb

• Assessed as unfit- or frail-AML;
• Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
• Cerebrovascular events (including transient ischemic attacks), etc.
• Patients deemed by the investigator to be unsuitable for participation in the study

• The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
• Age 18-65 years
• Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid leukemia; b. Therapy-related acute myeloid leukemia; c. AML with extramedullary/myeloid sarcoma; d. Age ≥60 years, assessed as fit-AML;
• Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
• Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for patients with liver involvement); total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2