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

Recruiting now · Phase 3

Conditions studied: AML, Adult

In brief

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.

Key facts

Study ID

NCT07132684

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

240

Starts

2025-08-31

Expected to finish

2028-08-30

Last updated by the study team

2026-03-02

Who can join

Age: 55 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Blood Diseases Hospital — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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