Study of SA+X in the Treatment of Newly Diagnosed AML

Prior treatment

• Current concurrent malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, in situ breast/cervical carcinoma, or other malignancies adequately controlled without treatment for more than 6 months;
• Subjects who have received previous anti-AML therapies other than hydroxyurea for cytoreduction, including but not limited to BCL-2, FLT3, IDH1 inhibitors, or other investigational agents;

Other illness

• Subjects with a history of myeloproliferative neoplasms (MPN);
• Subjects with a history of chronic myeloid leukemia (CML);
• Hypersensitivity or allergy to any of the study drugs;
• Physical conditions or organ system dysfunction that impairs the ability to swallow capsules or tablets, or significantly affects gastrointestinal function and/or absorption (including malabsorption syndrome, small bowel resection, or uncontrolled inflammatory bowel disease);
• Other uncontrolled active infection (as judged by the investigator);

Lab values

• Cardiac conditions meeting any of the following:a) Long QT syndrome or QTc interval \> 480 ms;b) Second- or third-degree atrioventricular block; severe, uncontrolled arrhythmia requiring medical treatment;c) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other treatable arrhythmia, clinically significant pericardial disease within 6 months prior to enrollment; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities;
• Significantly abnormal liver or renal function (serum bilirubin, AST, ALT, or serum creatinine \> 3 × upper limit of normal; excluding those deemed by the investigator to be related to AML);
• HIV infection, syphilis infection, HCV infection, or active HBV infection (HBsAg positive; or HBsAg negative / HBcAb positive with HBV DNA \> 1.0 × ULN); Patients with previously documented such infections who have achieved undetectable viral load or sustained viral load reduction after treatment may be enrolled at the investigator's discretion;

Other

• FAB classification as M3, or molecularly confirmed APL
• Refractory / relapsed subjects
• Subjects with mixed phenotype acute leukemia (MPAL);
• Documented central nervous system leukemia;
• Coagulopathy unrelated to AML;
• Pregnant or breastfeeding women;
• Unable to understand or comply with the study protocol;
• Participation in other relevant clinical studies within 30 days (excluding diagnostic studies);
• Subjects deemed inappropriate for study participation by the investigator.

• Newly diagnosed AML confirmed by bone marrow morphology and immunophenotyping (5th edition WHO diagnostic criteria)
• Subjects with APL excluded according to fusion gene and chromosome results
• ECOG performance status 0-3
• Age ≥ 18 years
• White blood cell count must be \< 25 × 10⁹/L at the start of study treatment (can be reduced by leukapheresis and/or hydroxyurea)
• Subjects must have adequate organ function, defined as follows: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), unless elevated due to leukemic organ involvement; serum total bilirubin \< 3 × ULN; higher levels are acceptable if attributable to ineffective erythropoiesis, leukemic organ involvement, or Gilbert syndrome; serum creatinine \< 3 × ULN, or estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula
• Written informed consent obtained from the subject or legal representative