Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients

Applying hypomethylating agents, azacitidine or decitabine as maintenance therapy in favorable-risk AML may prolong the remission duration and further improve their long-term survival.

Inclusion criteria

• Patients aged ≥16 years;
• Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2022;
• Patients achieved remission after induction therapy and finished at least 3 cycles of high-dose Aar-C based consolidation therapy, remaining in minimal residual disease (MRD) negative remission status (For NPM1-mutated and core binding factor acute myeloid leukemia (CBF-AML), MRD negative is defined as <2%, CEBPA-mutated AML, MRD negative is defined as <0.1%).
• Patients not receiving hematopoietic stem cell transplantation prior to enrollment;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Expected survival time ≥ 3 months;
• No serious heart, lung, liver or kidney disease;
• Have the ability to understand and be willing to sign the informed consent form for this trial.

Exclusion criteria

• Patients experienced hematologic relapse before recruitment.
• Patients who are allergic to the study drug or drugs with similar chemical structures.
• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
• 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.
• Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, Alanine Aminotransferase (ALT) / Aspartate Aminotransferase (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 Corrected QT Interval (QTc) 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.
• 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).
• Patients not suitable for the study according to the investigator's assessment.