VAH vs VA in Newly Diagnosed Elderly AML
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60-75
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Venetoclax
- Azacitidine
- Homoharringtonine
Treatment groups
308 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov