Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- The First Affiliated Hospital of Zhejiang University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Newly diagnosed acute myeloid leukemia (AML) confirmed according to the World Health Organization (WHO) classification;
- Classified as intermediate- or adverse-risk AML based on the European LeukemiaNet (ELN) 2022 genetic risk stratification;
- Age 18-65 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- 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;
- Normal cardiac function, defined as left ventricular ejection fraction (LVEF) >50%;
- Life expectancy ≥3 months;
- Signed written informed consent by the patient or their legally authorized representative prior to study enrollment.
Exclusion Criteria:
- Acute promyelocytic leukemia;
- Central nervous system involvement by leukemia;
- History of other malignancies within the past 5 years;
- Positive for human immunodeficiency virus (HIV);
- Presence of any other serious medical condition that may limit study participation, including advanced infections, uncontrolled diabetes mellitus, severe cardiac insufficiency, or angina;
- Ineligible for intensive chemotherapy due to poor general condition;
- Pregnant or breastfeeding women;
- Inability to understand or comply with the study protocol;
- Inability to take oral medication or presence of malabsorption syndrome;
- Prior treatment with B-cell lymphoma 2 (BCL-2) inhibitors or hypomethylating agents, or current participation in any other investigational drug study;
- Inability or unwillingness to provide written informed consent.
学习计划
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 |
|---|---|
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实验性的：Arm A: Lisaftoclax+Daunorubicin+Cytarabine
Participants received induction chemotherapy with lisaftoclax, daunorubicin, and cytarabine. Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen. Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles. After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy. Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first. |
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：
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
其他名称：
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
其他名称：
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实验性的：Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin
Participants received induction chemotherapy with lisaftoclax, homoharringtonine, cytarabine, and aclarubicin. Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen. Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles. After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy. Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first. |
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
其他名称：
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
其他名称：
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：
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有源比较器：Arm C: Daunorubicin+cytarabine
Participants received induction chemotherapy with daunorubicin and cytarabine. Patients achieving partial response (PR) with a reduction in bone marrow blasts >60% were allowed to receive one additional cycle of the same regimen. Patients who achieved complete response received consolidation therapy with lisaftoclax in combination with intermediate-dose cytarabine for 3 cycles. After completion of consolidation therapy, next-generation sequencing (NGS) was performed. Patients with minimal residual disease (MRD) negativity did not receive maintenance therapy, whereas patients with MRD positivity proceeded to maintenance therapy. Maintenance therapy consisted of lisaftoclax in combination with azacitidine, administered for up to 1 year or 10 cycles, whichever occurred first. |
Lisaftoclax (600 mg, orally, D1-7) + intermediate-dose cytarabine (2 g/m², q12h, D1-3) for 3 cycles
其他名称：
Lisaftoclax (400 mg, orally, D1-7) + azacitidine (50 mg/m², D1-7) for up to 1 year or 10 cycles, whichever occurred first.
其他名称：
Daunorubicin (60 mg/m², iv, qd, D1-3) + cytarabine (100 mg/m², q12h, subcutaneous injection or iv infusion, D1-7).
其他名称：
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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 |
|---|---|---|
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2-year event-free survival (EFS) rate
大体时间：from randomization up to 2 years after randomization
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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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete Response (CR) rate after 1/2 treatment cycles
大体时间：At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
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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 induction chemotherapy (each cycle is 28 days)
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Composite Complete Response (CRc) rate after 1/2 treatment cycles
大体时间：At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
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defined as the proportion of patients achieving CRc after the first or second cycle of induction chemotherapy.
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At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
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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 induction chemotherapy (each cycle is 28 days)
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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
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At the end of Cycle 1 or Cycle 2 induction chemotherapy (each cycle is 28 days)
|
|
2-year overall survival rate (OS)
大体时间：from randomization up to 2 years
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defined as the proportion of patients who were still alive from the time of randomization for the last patient until 24 months later
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from randomization up to 2 years
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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
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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.
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from the date of complete remission (CR/CRi) up to 2 years after achieving response
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Safety and Tolerability
大体时间：up to 24 months
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defined as the number of participants with adverse events and serious adverse events as assessed by NCI CTCAE v5.0
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up to 24 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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