Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia

Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus 3+7 Regimen in Fit Older Patients With Acute Myeloid Leukaemia：A Multicenter, Randomized, Controlled, Phase 3 Trial

This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.

Inclusion Criteria:

1. Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures;
2. Age between 60-75 years at the time of screening, with no gender restrictions;
3. Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;
4. No severe allergic constitution;
5. Liver function: ALT and AST <= 2.5 times the upper limit of normal values, bilirubin <= 2 times the upper limit of normal values;
6. Renal function: creatinine <= upper limit of normal values;
7. No uncontrollable infections or severe mental illnesses;
8. Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.

Exclusion Criteria:

1. Patients who are allergic to the study medication or have contraindications to it;
2. Pregnant or breastfeeding women;
3. Patients with active infections;
4. Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;
5. Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;
6. Patients who have undergone major organ surgery within the last 6 weeks;
7. Abnormal liver function, with total bilirubin > 1.5 times the upper limit of normal, ALT/AST > 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT/AST > 5 times the upper limit of normal; abnormal renal function, with serum creatinine > 1.5 times the upper limit of normal;
8. Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).