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VAH vs VA in Newly Diagnosed Elderly AML

ConditionsAcute Myeloid Leukemia (AML)Elderly Patients (60-75 Years)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: Experimental: VAHExperimental treatment 3 interventions
Group B: Active Comparator: VAActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Composite Complete Remission Rate (CRc)

The proportion of randomized participants who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), according to the 2022 ELN criteria, from randomization up to the initiation of Cycle 3.

Time frame
Up to approximately 8 weeks (from randomization to initiation of Cycle 3; each cycle is planned as 28 days).

Secondary outcomes

1

Event-Free Survival (EFS)

Time from randomization to morphological relapse, initiation of subsequent therapy (while in CR/CRi), or death

Time frame
up to 36 months
2

Overall Survival (OS)

Time from randomization to death from any cause

Time frame
up to 36 months
3

CR/CRi Rate by Cycle 1 and Cycle 2

Proportion of patients achieving CR/CRi prior to the start of Cycle 2 and Cycle 3

Time frame
End of Cycle 1 and end of Cycle 2 (each cycle is planned as 28 days; assessments performed prior to initiation of Cycle 2 and Cycle 3)
4

Complete Remission (CR) Rate

The proportion of randomized participants who achieve complete remission (CR) according to the 2022 European LeukemiaNet (ELN) criteria. CR is defined as bone marrow blasts \<5%, absence of circulating blasts and extramedullary disease, absolute neutrophil count ≥1.0 ×10⁹/L, and platelet count ≥100 ×10⁹/L. Participants will be evaluated for CR from randomization through the end of Cycle 3. Participants who do not undergo disease assessment within this period will be considered non-responders for this endpoint.

Time frame
From randomization through the end of Cycle 3 (approximately 12 weeks).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

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