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

Summary

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.

Eligibility

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.

Conditions2

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