Luspatercept for CIA in AML
2026年6月17日 更新者：Qing Zhang、Guangdong Second Provincial General Hospital
Efficacy and Safety of Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study
This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.
研究概览
详细说明
The application of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML has not yet been systematically studied.
Animal studies have shown that rotegcipipone can improve the recovery of anemia after chemotherapy.
The bone marrow microenvironment after chemotherapy is often deteriorated due to cytokine storms and hematopoietic stem cell damage, which may further exacerbate erythroid regeneration disorders.
Based on rotegcipipone's dual mechanism of improving the hematopoietic microenvironment and promoting erythrocyte maturation, it may overcome the limitations of existing therapies after chemotherapy.
Furthermore, its safety profile (primarily grade 1-2 adverse reactions in MDS and β-thalassemia) provides a potential advantage for its application in vulnerable patients after chemotherapy.
研究类型
介入性
注册 (估计的)
40
阶段
- 阶段2
- 阶段1
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
- 姓名：Guopan Yu, PhD
- 电话号码：+8615876559968
- 邮箱：yugpp@163.com
研究联系人备份
- 姓名：Tianmiao Yu, Master
- 邮箱：yutm96@163.com
学习地点
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Guangdong
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Guangzhou、Guangdong、中国
- 招聘中
- Department of Hematology, Guangdong Second Provincial General Hospital
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接触：
- Guopan Yu, PhD
- 电话号码：+8615876559968
- 邮箱：yugpp@163.com
-
接触：
- Tianmiao Yu, Master
- 邮箱：yutm96@163.com
-
-
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
接受健康志愿者
不
描述
Inclusion Criteria:
- De novo AML patients;
- Age ≥ 18 years and ≤ 60 years;
- AML with ELN2022-low risk
- Received 1-3 cycles of HDAC consolidation therapy
- HGB 60-90 G/L
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
- Life expectancy ≥ 3 months;
- Signed informed consent and able to understand and comply with the procedures required by this protocol.
Exclusion Criteria:
- t-AML/sAML
- Concurrent myelofibrosis
- Patients unresponsive to red blood cell transfusions
- Heart function < grade 2
- Renal function: creatinine clearance < 30 ml/min
- Liver function: ALTd > 5 times normal, bilirubin > 3 times normal
- Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
- History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs/symptoms that do not improve despite appropriate antibiotic, antiviral, and/or other treatments), known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection, and/or hepatitis C. (HCV) infection
- History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
- Pregnant or breastfeeding women
- Patients deemed unsuitable for enrollment by the investigators
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：不适用
- 介入模型：单组作业
- 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：Rotesip treatment group
Patients were screened and enrolled in the treatment group to evaluate the efficacy and safety of rotezipeptide in the treatment of chemotherapy-inducing anemia in AML.
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First, enrolled patients were randomized to received rotezipeptide with a dosage of 1mg/kg at the day 1 versus day 10 post chemotherapy.
Each groups were analyzed to enroll et least 10 patients.
Second, after working out which day should be the better one for the treatment of rotezipeptide in phase 1 study, at least 20 patients were enrolled to received rotezipeptide with the same dose at the above day to further work out the efficacy and safety of rotezipeptide in the treatment of CIA in AML.
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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 |
|---|---|---|
|
Time of 50% increase in hemoglobin levels from baseline
大体时间：Days 1-28 post chemotherapy
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The time of hemoglobin levels increasing 50% from baseline
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Days 1-28 post chemotherapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Duration of HGB < 60 G/L during the treatment course (1-28 days)
大体时间：Days 1-28 after AML chemistry treatment
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The duration of HGB < 60 G/L during this consolidation treatment course (days 1-28);
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Days 1-28 after AML chemistry treatment
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Incidence of HGB < 60 G/L during the treatment course (days 1-28)
大体时间：Days 1-28 after chemotherapy
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The incidence of HGB < 60 G/L during this consolidation treatment course (days 1-28);
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Days 1-28 after chemotherapy
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Red blood cell transfusion volume
大体时间：Days 1-28 after AML chemistry treamtment
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Red blood cell transfusion volume during this consolidation treatment course (days 1-28);
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Days 1-28 after AML chemistry treamtment
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MRD negative rate
大体时间：6 months after AML chemistry treamtment
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MRD negative rate within 6 months;
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6 months after AML chemistry treamtment
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Anemia recurrence rate
大体时间：12 months after AML chemistry treamtment
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Relapse rate 12 months after chemotherapy;
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12 months after AML chemistry treamtment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of people experiencing treatment-related adverse events
大体时间：Days 1-28 after Luspatercept treatment
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According to the CTCAE v5.0 assessment, the number of people who experienced treatment-related adverse events included both hematological and non-hematological toxicities.
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Days 1-28 after Luspatercept treatment
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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。
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)
2026年12月31日
研究完成 (估计的)
2027年5月31日
研究注册日期
首次提交
2026年6月6日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
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.