Venetoclax Combined With Azacitidine for Consolidation Therapy in AML

NCT07425782 | Recruiting Phase 2

• 1 other identifier: SZ3301
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia; Consolidation Therapy; Venentoclax; High Risk; Hematopoietic Stem Cell Transplant (HSCT)

Keywords

Acute Myeloid Leukemia; Consolidation Therapy; Venentoclax; Allogenice Hematopoietic Stem Cell Transplantation; High risk

Outcome Measures

Primary Outcomes (1)

• Leukemia free survival

  Time from date of achieving complete remission until date of first documented hematologic relapse, extramedullary relapse, or death from any cause, whichever occurs first.

  From date of complete remission until the date of first documented relapse or date of death from any cause, whichever came first, assessed up to 2 years.

Secondary Outcomes (4)

• Pretransplantation MRD negative rate

  From the end of the last consolidation therapy to the initiation of conditioning regimen for allogeneic hematopoietic stem cell transplantation, within approximately 1 month.

• Overall survival

  From the first day of randomization to the date of death, assesed up to 2 years.

• Cumulative relapse rate

  From date of achieving remission to the date of death from any cause, assessed up to 2 years.

• Non-relapse mortality

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

Study Arms (2)

Ara-C Consolidation Arm

ACTIVE COMPARATOR

AraC (Cytarabine) 1-2 g/m², administered intravenously every 12 hours on days 1-3, may be combined with anthracycline/anthraquinone agents. After completing 1-2 cycles of consolidation therapy, the patient proceeds to allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Drug: Ara-C Group

VA Consolidation Chemotherapy Arm

EXPERIMENTAL

VEN: 400 mg, orally, days 1-28 (Venetoclax dosage must be adjusted per prescribing information/guidelines based on concomitant use of CYP3A4 inhibitors); AZA: 75 mg/m²/day, subcutaneously, days 1-7; Proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT) after completing 1-2 cycles of consolidation therapy.

Drug: VEN/AZA condsolidation

Interventions

Ara-C Group DRUG

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.

Ara-C Consolidation Arm

VEN/AZA condsolidation DRUG

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.

VA Consolidation Chemotherapy Arm

Eligibility Criteria

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

You may qualify if:

• Diagnosis of AML confirmed by bone marrow morphology, flow cytometry, and molecular genetics, meeting WHO 2022 classification criteria;
• Age ≥ 18 years;
• Classified as high-risk according to the European LeukemiaNet (ELN) prognostic risk stratification for AML, including AML with myelodysplasia-related changes (AML-MRC) and therapy-related acute myeloid leukemia (t-AML);
• Achieved CR or CRi after ≤ 2 cycles of VA induction chemotherapy;
• Availability of a suitable donor, with plans to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
• Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 2 times ULN; left ventricular ejection fraction (LVEF) ≥ 50% as shown by echocardiography (ECHO); expected survival \> 8 weeks;
• Voluntarily signed the informed consent form and can understand and comply with study requirements.

You may not qualify if:

• Presence of clinically active cardiovascular disease, such as uncontrolled ventricular arrhythmia, uncontrolled hypertension, congestive heart failure, cardiac disease classified as Class 3 or 4 according to the New York Heart Association (NYHA) Functional Classification, or a history of myocardial infarction within 3 months prior to screening;
• Active central nervous system leukemia (CNSL) or extramedullary infiltration of leukemia;
• Other serious diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);
• Known human immunodeficiency virus (HIV) infection or uncontrolled severe viral hepatitis;
• Pregnant or breastfeeding women;
• Inability to understand, comply with the study protocol, or sign the informed consent form;
• Any other conditions deemed by the investigator as unsuitable for participation in this study.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

the First Affiliated Hosptital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qi Qu

CONTACT

+86 051267976801; 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 of Hematology. Clinical Professor. Principal Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 26, 2028
• Study Completion (Estimated): November 26, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)