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VA Consolidation in Intermediate-Risk AML

2026年8月4日 更新者：CHEN Jia、The First Affiliated Hospital of Soochow University

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

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).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The goal of this prospective, randomized, open-label, multi-center study is to demonstrate that consolidation therapy with venetoclax + azacitidine (VA) is non-inferior to conventional intensive chemotherapy (cytarabine-based regimens) in this specific patient population, while offering a more favorable safety profile.Eligible patients will be randomized 1:1 to receive either 1-2 cycles of VA (Venetoclax 400mg d1-28 + Azacitidine 75mg/m² d1-7) or 1-2 cycles of intermediate/high-dose cytarabine (AraC) ± anthracycline. The primary endpoint is 2-year Leukemia-Free Survival (LFS). Secondary endpoints include pre-transplant MRD-negative rate, Overall Survival (OS), Cumulative Incidence of Relapse (CIR), Non-Relapse Mortality (NRM), and safety profile (CTCAE v5.0). This study will provide high-level evidence for consolidation therapy in intermediate-risk AML in the venetoclax era.

研究类型

介入性

注册 (估计的)

226

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Jiangsu
      • Suzhou、Jiangsu、中国
        • 招聘中
        • The First Affiliated Hospital of Soochow University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Venetoclax + Azacitidine Consolidation

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.
药品：Venetoclax and Azacitidine

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.
有源比较器：Conventional Consolidation Chemotherapy

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.
药品：Cytarabine ± Anthracycline

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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Leukemia-Free Survival (LFS)
大体时间：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.
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.

次要结果测量

结果测量
措施说明
大体时间
Pretransplantation MRD-Negative Rate
大体时间：From the end of the last consolidation therapy to the initiation of conditioning regimen for allo-HSCT, approximately within 1 month.
Proportion of patients who achieve minimal residual disease (MRD) negativity prior to hematopoietic stem cell transplantation, as assessed by multi-parameter flow cytometry.
From the end of the last consolidation therapy to the initiation of conditioning regimen for allo-HSCT, approximately within 1 month.
Overall Survival (OS)
大体时间：From the first day of randomization to the date of death from any cause, assessed up to 2 years.
From the first day of randomization to the date of death from any cause, assessed up to 2 years.
Cumulative Incidence of Relapse (CIR)
大体时间：From the date of randomization to the date of hematologic relapse, assessed up to 2 years.
From the date of randomization to the date of hematologic relapse, assessed up to 2 years.
Non-Relapse Mortality (NRM)
大体时间：From the date of randomization until the date of death without prior relapse or disease progression, assessed up to 2 years.
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)
大体时间：Throughout the consolidation treatment period and up to 30 days post-treatment.
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Throughout the consolidation treatment period and up to 30 days post-treatment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The First Affiliated Hospital of Soochow University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2030年6月1日

研究完成 (估计的)

2030年6月1日

研究注册日期

首次提交

2026年6月19日

首先提交符合 QC 标准的

2026年6月19日

首次发布 (实际的)

2026年6月26日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年8月4日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SZ3705

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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