NCT07469046

VAH vs VA in Newly Diagnosed Elderly AML

Venetoclax, Azacitidine Combined With Homoharringtonine Versus Venetoclax and Azacitidine in Newly Diagnosed Elderly (60-75 Years) Acute Myeloid Leukemia: A Multicenter, Open-label, Randomized, Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized, controlled phase III clinical trial designed to evaluate the efficacy and safety of the combination of Venetoclax, Azacitidine, and Homoharringtonine (VAH) compared to Venetoclax and Azacitidine (VA) alone in newly diagnosed elderly patients with Acute Myeloid Leukemia (AML). A total of 308 treatment-naïve patients aged 60-75 years with AML (non-APL) will be enrolled and randomly assigned in a 1:1 ratio to either the control arm (VA) or the experimental arm (VAH). The study aims to determine if the addition of Homoharringtonine to the standard VA regimen can improve response rates. To mitigate bias in this open-label study, the primary and key secondary efficacy endpoints will be assessed by an Independent Review Committee or central laboratory blinded to treatment allocation.

Conditions

• Acute Myeloid Leukemia (AML)
• Elderly Patients (60-75 Years)

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax: 100 mg orally on Day 1, 200 mg on Day 2, then 400 mg orally on Days 3-28 of a 28-day cycle (dose ramp-up recommended for newly diagnosed patients).
DRUG	Azacitidine	Azacitidine: 75 mg/m² subcutaneously or intravenously on Days 1-7.
DRUG	Homoharringtonine	Homoharringtonine (HHT): 1 mg/m² intravenously on Days 1-7.

Timeline

• Start date: 2026-04-10
• Primary completion: 2028-03-31
• Completion: 2029-03-31
• First posted: 2026-03-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China