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VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia.

2026年6月7日 更新者：Hematology department of the 920th hospital

VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Controlled Trial

Objective: This clinical trial aims to compare the efficacy and safety of the VA-CAG regimen administered as a two-week schedule versus a three-week schedule for induction remission in acute myeloid leukemia (AML).

Key Research Questions:

  1. Is the efficacy of the two-week VA-CAG regimen equivalent to that of the three-week regimen in inducing remission in AML?
  2. Does the two-week VA-CAG regimen reduce treatment-related adverse events compared to the three-week regimen? Methods: Researchers will compare the efficacy and safety of the two-week VA-CAG regimen with the three-week regimen for induction remission in AML. Study participants will be randomly assigned to receive standard treatment with either the two-week or three-week VA-CAG regimen. Patients are required to attend monthly follow-up visits for a total of one year. At each follow-up, the following assessments will be performed: complete blood count, liver and kidney function tests, bone marrow aspiration, flow cytometric measurement of minimal residual disease (MRD), and/or fusion gene analysis, along with monitoring of other efficacy endpoints and adverse reactions.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

110

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

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:

  1. Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines;
  2. Age 18-75 years;
  3. Body weight 30-100 kg;
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3;
  5. No significant organ dysfunction (echocardiographic ejection fraction >45%; bilirubin <2 times the upper limit of normal; AST and ALT <3 times the upper limit of normal; serum creatinine <2 times the upper limit of normal);
  6. No severe infections;
  7. Study participants voluntarily agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

  1. Patients with other types of diseases;
  2. Patients with a projected survival of less than 1 month;
  3. History of prior treatment;
  4. Severe psychiatric or neurological disorders that impair the ability to provide informed consent and/or report or observe adverse events;
  5. Other circumstances deemed unsuitable for enrollment 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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：2-week VACAG regimen for newly diagnosed acute myeloid leukemia

Specific Medication for the 2-week VACAG regimen Protocol:

Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;
药品：Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.

Specific Medication for the VACAG Protocol:

  1. Two-week regimen group Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, G-CSF: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;
  2. Three-week regimen group Venetoclax administered for 21 days; dosage and administration are the same as in the 2-week regimen group.
有源比较器：3-week VACAG regimen for newly diagnosed acute myeloid leukemia

Specific Medication for the 3-week VACAG regimen Protocol:

Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-21, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;
药品：Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.

Specific Medication for the VACAG Protocol:

  1. Two-week regimen group Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, G-CSF: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;
  2. Three-week regimen group Venetoclax administered for 21 days; dosage and administration are the same as in the 2-week regimen group.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
CR率
大体时间：在感应周期1结束时（每个周期约为30天）
在感应周期1结束时（每个周期约为30天）

次要结果测量

结果测量
措施说明
大体时间
不利事件
大体时间：从归纳的第一天到下一个治疗周期的开始（最多60天）
安全性和耐受性分析将通过第5.0版的不良事件（CTCAE）的共同毒性标准评估。
从归纳的第一天到下一个治疗周期的开始（最多60天）
缓解持续时间
大体时间：从第一次缓解日期到复发日期（评估长达30个月）
DOR被定义为从获取CR到复发的时期
从第一次缓解日期到复发日期（评估长达30个月）
最小残留疾病负缓解率（MRD阴性率）
大体时间：诱导1周期后（每个周期约为30天）
在开始合并治疗之前，通过流式细胞仪转换为MRD <10^-3的参与者的百分比。
诱导1周期后（每个周期约为30天）

其他结果措施

结果测量
措施说明
大体时间
Overall survival
大体时间：From the first day of induction until the date of death from any cause, assessed up to 30 months.
Overall Survival will be defined as the time from administration of the initial doses until death from any cause.
From the first day of induction until the date of death from any cause, assessed up to 30 months.
Relapse-free survival
大体时间：From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months.
Relapse-free survival will be defined as the time since date of CR until either relapse or death in remission.
From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months.

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

Hematology department of the 920th hospital

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 (估计的)

2026年6月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年5月31日

首先提交符合 QC 标准的

2026年6月7日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月7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

  • km-09

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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