Daunorubicin/Idarubicin: Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy.
Cytarabine: Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy.
Azacitidine: Azacitidine is used in VA regimen
Venetoclax: Venetoclax is used in VA regimen
Study 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
Sex
ALL
Min age
55 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall Survival (OS) — up to 1 years after completion of enrollment Time from randomization to death from any cause.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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