A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies

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.