VAH vs VA in Newly Diagnosed Elderly AML (NCT07469046) | Clinical Trial Compass
Not Yet RecruitingPhase 3
VAH vs VA in Newly Diagnosed Elderly AML
China308 participantsStarted 2026-04-10
Plain-language 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.
Who can participate
Age range60 Years – 75 Years
SexALL
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Inclusion Criteria:
* Diagnosis of acute myeloid leukemia (AML), non-APL, according to the 2022 International Consensus Classification (ICC) criteria.
* Age 60 to 75 years, inclusive.
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
* Adequate organ function unless abnormalities are considered due to leukemic organ involvement:
Serum creatinine ≤ 1.5 × upper limit of normal (ULN). Oxygen saturation \> 92% on room air. Total bilirubin ≤ 3.0 × ULN. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN.
If laboratory abnormalities are considered due to leukemic organ involvement, total bilirubin ≤ 5.0 × ULN and ALT/AST ≤ 5.0 × ULN are permitted.
* Female subjects of childbearing potential must be postmenopausal or surgically sterile. Male subjects must agree to use effective contraception or abstain from sperm donation from study start through 90 days after the last dose of study treatment.
* Ability to understand and voluntarily sign an informed consent form prior to any study-related procedures.
Exclusion Criteria:
* Prior treatment with hypomethylating agents for myelodysplastic syndrome (MDS). Prior chemotherapy for AML, except hydroxyurea. Prior CAR-T cell therapy.
* Prior investigational therapy for AML.
* Documented history of myeloproliferative neoplasm (MPN).
* Favorable-risk AML according to 2022 European LeukemiaNet (ELN) criteria.
* Known active central nervous system (CNS) …
What they're measuring
1
Composite Complete Remission Rate (CRc)
Timeframe: Up to approximately 8 weeks (from randomization to initiation of Cycle 3; each cycle is planned as 28 days).
Trial details
NCT IDNCT07469046
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine