Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients

A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy

This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.

Inclusion Criteria:

• Diagnosis of AML according to WHO (2022) or ICC criteria.

• Age ≥55 and ≤75 years.

• ECOG performance status score of 0-2.

• Adequate organ function:

  • Total bilirubin ≤1.5× upper limit of normal (ULN)
  • AST and ALT ≤2.5× ULN
  • Serum creatinine <2× ULN
  • Cardiac enzymes <2× ULN
  • Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative.

Exclusion Criteria:

• Acute promyelocytic leukemia with PML-RARA fusion gene.
• AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.
• AML with BCR-ABL fusion gene.
• Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).
• Concurrent other malignancies requiring treatment.
• Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal).
• Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
• Other conditions deemed unsuitable by the investigator.