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NOT YET RECRUITING
NCT07425782
PHASE2

Venetoclax Combined With Azacitidine for Consolidation Therapy in AML

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the efficacy and safety of a venetoclax-based consolidation therapy versus conventional consolidation chemotherapy in newly diagnosed adult patients with high-risk acute myeloid leukemia (AML) who have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned for transplantation. The main questions it aims to answer are: Does consolidation therapy with a venetoclax-containing regimen lead to superior clinical outcomes compared to conventional chemotherapy in this specific patient population? What is the comparative safety profile of the venetoclax-containing consolidation regimen versus conventional chemotherapy in these patients? Participants will be randomly assigned to receive either the venetoclax-based consolidation therapy or the conventional consolidation chemotherapy before undergoing transplantation.

Official title: A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2026-02-01

Completion Date

2028-11-26

Last Updated

2026-02-23

Healthy Volunteers

No

Conditions

Acute Myeloid LeukemiaConsolidation TherapyVenentoclaxHigh RiskHematopoietic Stem Cell Transplant (HSCT)

Interventions

DRUG

Ara-C Group

Ara-C 1-2 g/m², every 12 hours, intravenous infusion, days 1-3; may be combined with anthracyclines/anthraquinones, followed by allo-HSCT after consolidation within 2 cycles.

DRUG

VEN/AZA condsolidation

Venetoclax 400 mg, orally, days 1-28 (the dose of Venetoclax should be adjusted according to the drug dosage instructions/guidelines when combined with CYP3A4 inhibitors); AZA: Azacitidine 75 mg/m² per day, subcutaneous injection, days 1-7. Patients will proceed to allo-HSCT after consolidation within 2 cycles.