RecruitingPhase 3NCT07132684

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

240 participants

Start Date

Aug 31, 2025

Study Type

INTERVENTIONAL

Conditions

AML, Adult

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

Min Age: 55 YearsMax Age: 75 Years

Inclusion Criteria9

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 Criteria8

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.