Clinical Research Directory

Inclusion Criteria: Patients meeting all of the following inclusion criteria can be included in this trial: * Age ≥ 18 years old; * According to the World Health Organization (WHO) classification, subjects diagnosed with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) should meet one of the following criteria: 1. Difficult to treat or recurrent (\>5% of primitive cells reappear in the bone marrow after complete remission) AML; (Single drug group) 2. Newly diagnosed AML subjects recognized by researchers as unable to receive standard treatment due to age, physical condition, or risk factors; (Joint group) * MDS subjects belong to the following prognostic risk categories according to the revised International Prognostic Scoring System (IPSS-R): 1. Extremely high-risk (\>6 points) 2. High risk (\>4.5 points - ≤ 6 points) 3. Medium risk (\>3 points - ≤ 4.5 points) * Clearly indicating the presence of IDH2 gene mutation; * Blood platelet (PLT) ≥20×10\^9/L； Or subjects with PLT\<20 × 10\^9/L, but recognized by the researchers as being caused by tumor reasons; * Serum total bilirubin ≤ 1.5 × ULN (for Gilbert syndrome subjects, bilirubin ≤ 3 × ULN); * Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml/min; * Recovery of toxic reactions caused by surgery, radiation therapy, or other anti-tumor treatments to ≤ Grade I; * Women should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Male participants must agree to use contraception during the study period and within 6 months after the end of the study period; * The subjects voluntarily joined this study. Exclusion Criteria: * Subjects who experience relapse after bone marrow transplantation; * Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug; * Individuals who have participated in clinical trials of other drugs within the four weeks prior to using the investigational drug; * Individuals with multiple factors that affect oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction; * Subjects who have previously used targeted isocitrate dehydrogenase 2 (IDH2) inhibitors; * The subject has uncontrolled systemic fungal, bacterial, or viral infections; * High blood pressure subjects who are still poorly controlled despite drug treatment; * Obvious cardiovascular diseases, such as heart failure classified as grade 2 or above by the New York Heart Association (NYHA), unstable angina in the past 3 months, myocardial ischemia or infarction, arrhythmia and grade I heart failure, or the presence of other factors at risk of prolonging the QT interval (such as arrhythmia, hypokalemia ≥ grade 3, family history of long QT interval); * Severe leukemia complications that endanger life, such as uncontrolled bleeding, hypoxia or shock pneumonia, disseminated intravascular coagulation; * Subjects known to have central nervous system leukemia or clinical symptoms of central nervous system leukemia; * Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; * Subjects with active replication of hepatitis B virus and hepatitis C virus; * Individuals with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; * According to the researcher's judgment, there are accompanying diseases that pose a serious threat to the safety of the subjects or affect their ability to complete the study.