VAH vs VA in Newly Diagnosed Elderly AML

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.

NCT Number	NCT07469046
Lead Sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions	Acute Myeloid Leukemia (AML), Elderly Patients (60-75 Years)
Enrollment	308 participants
Start Date	2026-04-10
Primary Completion	2028-03-31 (estimated)
Study Completion	2029-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-13