VAH vs VA in Newly Diagnosed Elderly AML

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT07469046
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
60 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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).
  • Azacitidine — DRUG
    Azacitidine: 75 mg/m² subcutaneously or intravenously on Days 1-7.
  • Homoharringtonine — DRUG
    Homoharringtonine (HHT): 1 mg/m² intravenously on Days 1-7.

Study Details

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.

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: VAH
    Patients receive Venetoclax, Azacitidine, and Homoharringtonine
  • Active Comparator: Active Comparator: VA
    Patients receive Venetoclax and Azacitidine

Primary Outcome Measure

Composite Complete Remission Rate (CRc) [ Time Frame: Up to approximately 8 weeks (from randomization to initiation of Cycle 3; each cycle is planned as 28 days). ]

Central Contacts

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