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Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy

2026年6月11日 更新者：Huafeng Wang、First Affiliated Hospital of Zhejiang University

A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy

This is a phase II/III, multicenter, randomized, three-arm, open-label, parallel controlled trial. The primary objective of this study is to compare the 2-years OS rate of the LDA, LHAA, and LA regimens in newly diagnosed patients with intermediate- and high-risk acute myeloid leukemia who are eligible for intensive chemotherapy.

研究概览

地位

邀请报名

条件

干预/治疗

研究类型

介入性

注册 (估计的)

450

阶段

  • 阶段2
  • 第三阶段

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。

学习地点

  • 中国
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310000
        • The First Affiliated Hospital of Zhejiang University

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Newly diagnosed acute myeloid leukemia (AML) confirmed according to the World Health Organization (WHO) classification;
  2. Classified as intermediate- or adverse-risk AML based on the European LeukemiaNet (ELN) 2022 genetic risk stratification (see Appendix Table 1);
  3. Age 15-65 years;
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  5. Adequate hepatic and renal function: total bilirubin ≤2 mg/dL (35 μmol/L); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2× the upper limit of normal; serum creatinine ≤177 μmol/L;
  6. Normal cardiac function, defined as left ventricular ejection fraction (LVEF) >50%;
  7. Life expectancy ≥3 months;
  8. Signed written informed consent by the patient or their legally authorized representative prior to study enrollment.

Exclusion Criteria:

  1. Acute promyelocytic leukemia;
  2. Central nervous system involvement by leukemia;
  3. History of other malignancies within the past 5 years;
  4. Positive for human immunodeficiency virus (HIV);
  5. Presence of any other serious medical condition that may limit study participation, including advanced infections, uncontrolled diabetes mellitus, severe cardiac insufficiency, or angina;
  6. Ineligible for intensive chemotherapy due to poor general condition;
  7. Pregnant or breastfeeding women;
  8. Inability to understand or comply with the study protocol;
  9. Inability to take oral medication or presence of malabsorption syndrome;
  10. Prior treatment with B-cell lymphoma 2 (BCL-2) inhibitors or hypomethylating agents, or current participation in any other investigational drug study;
  11. Inability or unwillingness to provide written informed consent.

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：Arm A: Lisaftoclax+Daunorubicin+Cytarabine

Participants received induction therapy with lisaftoclax, daunorubicin, and cytarabine.

Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle.

Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles.

For maintenance therapy, patients were classified as post-transplant or non-transplant. Post-transplant patients were randomized 1:1 to receive either lisaftoclax plus azacitidine or azacitidine alone. Non-transplant patients received lisaftoclax in combination with azacitidine.

Maintenance therapy was administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity.
药品：Lisaftoclax+daunorubicin+cytarabine
Lisaftoclax (200 mg on D2, 400 mg on D3, and 600 mg qd on D4-8, orally) + daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).
其他名称：
  • 诱导化疗
药品：Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
其他名称：
  • 合并处理
药品：Lisaftoclax+azacitidine or azacitidine
Post-transplant maintenance therapy: patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. The combination regimen consisted of lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Azacitidine monotherapy consisted of azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Non-transplant maintenance therapy: lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
其他名称：
  • 维持治疗
实验性的：Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin

Participants received induction therapy with lisaftoclax, homoharringtonine, cytarabine, and aclarubicin.

Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle.

Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles.

For maintenance therapy, patients were stratified according to transplantation status (post-transplant or non-transplant). Post-transplant patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. Non-transplant patients received combination maintenance therapy.

All maintenance therapies were administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity, and were interrupted until recovery to grade ≤2.
药品：Lisaftoclax+homoharringtonine+cytarabine+aclarubicin
Lisaftoclax (200 mg on D2, 400 mg on D3, and 600 mg qd on D4-8, orally) + homoharringtonine (2 mg/m², qd, intramuscular injection or iv infusion, D1-5) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-5) + aclarubicin (12 mg/m², maximum 20 mg, iv, D1-5).
其他名称：
  • 诱导化疗
药品：Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
其他名称：
  • 合并处理
药品：Lisaftoclax+azacitidine or azacitidine
Post-transplant maintenance therapy: patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. The combination regimen consisted of lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Azacitidine monotherapy consisted of azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Non-transplant maintenance therapy: lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
其他名称：
  • 维持治疗
实验性的：Arm C:Lisaftoclax+ azacitidine

Participants received induction therapy with lisaftoclax in combination with azacitidine.

Patients with partial response (PR) or >60% reduction in bone marrow blasts were allowed to receive one additional induction cycle.

Patients achieving complete response received consolidation therapy with lisaftoclax and intermediate-dose cytarabine for 3 cycles.

For maintenance therapy, patients were stratified according to transplantation status (post-transplant or non-transplant). Post-transplant patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. Non-transplant patients received combination maintenance therapy.

All maintenance therapies were administered for up to 1 year or 10 cycles, whichever occurred first, or until the occurrence of grade ≥4 hematologic toxicity, and were interrupted until recovery to grade ≤2.
药品：Lisaftoclax+ cytarabine
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
其他名称：
  • 合并处理
药品：Lisaftoclax+azacitidine or azacitidine
Post-transplant maintenance therapy: patients were randomized 1:1 to receive either combination therapy or azacitidine monotherapy. The combination regimen consisted of lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Azacitidine monotherapy consisted of azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first. Non-transplant maintenance therapy: lisaftoclax (400 mg, orally, D1-7) in combination with azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
其他名称：
  • 维持治疗
药品：Lisaftoclax+azacitidine
Lisaftoclax (200 mg, orally, D1; 400 mg, orally, D2; 600 mg, orally, qd, D3-28) + azacitidine (75 mg/m², D1-7)
其他名称：
  • 诱导化疗

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
2-year overall survival rate (OS)
大体时间：from randomization up to 2 years
defined as the proportion of patients who were still alive from the time of randomization for the last patient until 24 months later
from randomization up to 2 years

次要结果测量

结果测量
措施说明
大体时间
2-year event-free survival (EFS) rate
大体时间：from randomization up to 2 years after randomization
defined as the proportion of patients remaining free of treatment failure, hematologic relapse, MRD relapse, or death within 2 years after randomization.
from randomization up to 2 years after randomization
2-year relapse-free survival (RFS) rate
大体时间：from the date of complete remission (CR/CRi) up to 2 years after achieving response
defined as the proportion of patients who achieved complete response (CR) or complete remission with incomplete hematologic recovery (CRi) and remained alive without disease relapse within 2 years after achieving response.
from the date of complete remission (CR/CRi) up to 2 years after achieving response
Safety and Tolerability
大体时间：up to 24 months
defined as the number of participants with adverse events and serious adverse events as assessed by NCI CTCAE v5.0
up to 24 months
Complete Response (CR) rate after 1/2 treatment cycles
大体时间：At the end of Cycle 1 or Cycle 2 of induction chemotherapy (each cycle is 28 days)
defined as the proportion of patients achieving complete response (CR) after the first or second cycle of induction chemotherapy.
At the end of Cycle 1 or Cycle 2 of induction chemotherapy (each cycle is 28 days)
Composite Complete Response (CRc) rate after 1/2 treatment cycles
大体时间：At the end of Cycle 1 or Cycle 2 of induction chemotherapy (each cycle is 28 days)
defined as the proportion of patients achieving CRc after the first or second cycle of induction chemotherapy.
At the end of Cycle 1 or Cycle 2 of induction chemotherapy (each cycle is 28 days)
Minimal residual disease (MRD) negativity rate after 1-2 cycles of induction chemotherapy
大体时间：At the end of Cycle 1 or Cycle 2 of induction chemotherapy (each cycle is 28 days)
defined as the the proportion of patients with negative minimal residual disease (MRD) among patients who achieve complete remission after 1-2 cycles of induction chemotherapy
At the end of Cycle 1 or Cycle 2 of induction chemotherapy (each cycle is 28 days)

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

First Affiliated Hospital of Zhejiang 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3月1日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CN-ZY-26-02

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

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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