New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Prior treatment

• Surgery on the main organs within the past six weeks
• Drug abuse or long-term alcohol abuse that would affect the evaluation results
• Patients who have received organ transplants (excepting bone marrow transplantation)

Other illness

• Patients who are allergic to the study drug or drugs with similar chemical structures
• Active infection
• Active bleeding
• Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
• Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met

Lab values

• Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value)
• Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment

Age

• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception

Other

• Patients not suitable for the study according to the investigator's assessment

• Adults aged ≥ 18 and ≤ 70 years
• Patients diagnosed with AML according to 2016 WHO myeloid malignant disease diagnosis standard (Non-APL)
• Patients with AML must meet one of the following criteria, A or B:
  • A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) \< 50% and \> 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.
• ECOG performance status score less than 3
• Expected survival time ˃ 3 months
• Patients without serious heart, lung, liver, or kidney disease
• Ability to understand and voluntarily provide informed consent