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VA Consolidation in Intermediate-Risk AML

ConditionsAcute Myeloid LeukemiaIntermediate Risk Acute Myeloid LeukemiaConsolidation Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This clinical trial aims to compare the efficacy and safety of venetoclax-based consolidation therapy versus conventional consolidation chemotherapy (intermediate/high-dose cytarabine) in newly diagnosed adult patients with intermediate-risk acute myeloid leukemia (AML). Participants must have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO 2022 classification criteria;

Age ≥ 18 years;

Classified as intermediate-risk based on European LeukemiaNet (ELN) 2022 prognostic risk stratification;

Achieved first complete remission (CR) or CR with incomplete hematologic recovery (CRi) after ≤ 2 cycles of Venetoclax + Azacitidine (VA) induction therapy;

Disqualifiers

Clinically active cardiovascular disease (uncontrolled arrhythmia/hypertension, NYHA Class 3/4 heart failure, myocardial infarction within 3 months)

Active central nervous system (CNS) leukemia or extramedullary infiltration

Other serious diseases limiting participation (e.g., severe infection, renal failure)

Known HIV infection or uncontrolled severe viral hepatitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Venetoclax and Azacitidine

    Drug

    Venetoclax: 400 mg, orally, once daily on Days 1-28. (Dose adjustment required per prescribing information/guidelines when combined with CYP3A4 inhibitors). Azacitidine: 75 mg/m²/day, subcutaneously or intravenously, on Days 1-7. Patients will receive 1-2 cycles of this regimen before proceeding to allo-HSCT.

  • Cytarabine ± Anthracycline

    Drug

    Cytarabine (AraC): ≥6g/m² per cycle (e.g., 1-2g/m², every 12 hours on days 1-3), administered intravenously. May be combined with anthracycline/anthraquinone agents per standard practice. Patients will receive 1-2 cycles of this regimen before proceeding to allo-HSCT.

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: Venetoclax + Azacitidine ConsolidationExperimental treatment 1 intervention
Group B: Conventional Consolidation ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Leukemia-Free Survival (LFS)

Time from randomization to the first occurrence of relapse or death, whichever comes first.

Time frame
From the date of randomization to the date of first documented hematologic relapse, extramedullary relapse, or death from any cause, assessed up to 2 years.

Secondary outcomes

1

Pretransplantation MRD-Negative Rate

Proportion of patients who achieve minimal residual disease (MRD) negativity prior to hematopoietic stem cell transplantation, as assessed by multi-parameter flow cytometry.

Time frame
From the end of the last consolidation therapy to the initiation of conditioning regimen for allo-HSCT, approximately within 1 month.
2

Overall Survival (OS)

Time frame
From the first day of randomization to the date of death from any cause, assessed up to 2 years.
3

Cumulative Incidence of Relapse (CIR)

Time frame
From the date of randomization to the date of hematologic relapse, assessed up to 2 years.
4

Non-Relapse Mortality (NRM)

Time frame
From the date of randomization until the date of death without prior relapse or disease progression, assessed up to 2 years.

Other outcomes

Sponsors and contacts

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

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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