VA Consolidation in Intermediate-Risk AML

NCT07672262 | Recruiting Phase 2 DMC

• 1 other identifier: SZ3302
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Myeloid Leukemia; Intermediate Risk Acute Myeloid Leukemia; Consolidation Therapy

Outcome Measures

Primary Outcomes (1)

• Leukemia-Free Survival (LFS)

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

  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 (5)

• Pretransplantation MRD-Negative Rate

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

• Overall Survival (OS)

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

• Cumulative Incidence of Relapse (CIR)

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

• Non-Relapse Mortality (NRM)

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

• Incidence of Adverse Events (Safety Profile)

  Throughout the consolidation treatment period and up to 30 days post-treatment.

Study Arms (2)

Venetoclax + Azacitidine Consolidation

EXPERIMENTAL

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.

Drug: Venetoclax and Azacitidine

Conventional Consolidation Chemotherapy

ACTIVE COMPARATOR

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.

Drug: Cytarabine ± Anthracycline

Interventions

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.

Venetoclax + Azacitidine Consolidation

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.

Conventional Consolidation Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Has a suitable donor and is planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);
• ECOG performance status score 0 to 2
• Adequate organ function: creatinine clearance ≥ 50 mL/min; AST and ALT ≤ 3 × ULN; total bilirubin ≤ 2 × ULN; LVEF ≥ 50%; life expectancy \> 8 weeks
• Voluntarily signed informed consent form and able to comply with study requirements

You may not qualify if:

• 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
• Pregnant or breastfeeding women
• Inability to understand, comply with protocol, or sign informed consent
• Any other conditions deemed unsuitable by the investigator

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Qi Qu

CONTACT

+86-512-676976801; quqimedsz@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician，Associate Professor

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)