MedTrace Logo

VAH vs VA in Newly Diagnosed Elderly AML

NCT07469046 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2026-04-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2028-03-31
Completion
2029-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07469046 on ClinicalTrials.gov