Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation (ES after HSCT)
2026年5月3日 更新者：Xiao Hui Zhang
A Prospective Observational Cohort Study to Validate Engraftment Syndrome Phenotypes and Their Associations With Acute Graft-Versus-Host Disease and Clinical Outcomes After Hematopoietic Stem Cell Transplantation
Engraftment syndrome (ES) is an early inflammatory complication after hematopoietic stem cell transplantation (HSCT) and has been associated with subsequent transplant-related complications and adverse clinical outcomes. However, ES is clinically heterogeneous, and its relationship with acute graft-versus-host disease (aGVHD), survival, and other post-transplant outcomes remains incompletely defined.
This prospective observational cohort study aims to validate previously identified ES-associated risk factors, severity-oriented ES phenotypes, and their associations with grade II-IV aGVHD and clinical outcomes after HSCT. Patients undergoing HSCT will be prospectively followed for the development of ES, grade II-IV aGVHD, and clinical outcomes including overall survival, disease-free survival, relapse, and non-relapse mortality. The study will evaluate whether ES phenotypes and ES-related clinical characteristics can stratify patients according to subsequent aGVHD risk and post-transplant prognosis.
研究概览
研究类型
观察性的
注册 (估计的)
250
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：Yejun Wu
- 电话号码：+8618800181620
- 邮箱：wyejun1999@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
- 孩子
- 成人
- 年长者
接受健康志愿者
不适用
取样方法
非概率样本
研究人群
The study population will include patients who develop engraftment syndrome after allogeneic hematopoietic stem cell transplantation at the participating center.
Patients will be prospectively enrolled after the diagnosis of engraftment syndrome and followed for subsequent grade II-IV acute graft-versus-host disease and post-transplant outcomes, including overall survival, disease-free survival, relapse, and non-relapse mortality.
Clinical features, laboratory parameters, engraftment kinetics, and organ-injury markers related to engraftment syndrome will be collected to validate ES phenotypes and their prognostic significance.
描述
Inclusion Criteria:
- Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center.
- Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria.
- Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters.
- Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes.
- Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.
Exclusion Criteria:
- Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation.
- Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome.
- Patients with missing essential follow-up information for assessment of primary outcome measures.
- Patients who withdraw consent or decline participation in prospective follow-up.
- Patients enrolled in another study that, in the opinion of the investigators, may interfere with the observational assessment of engraftment syndrome phenotypes or post-transplant outcomes.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients With Engraftment Syndrome
Patients who develop engraftment syndrome after hematopoietic stem cell transplantation will be enrolled and prospectively followed.
Engraftment syndrome will be diagnosed according to predefined clinical criteria during the early post-transplant period.
Clinical features, laboratory parameters, transplant-related characteristics, ES phenotypes, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes will be recorded and analyzed.
|
No study-specific intervention will be administered.
Participants will receive standard clinical care after hematopoietic stem cell transplantation according to institutional practice and treating physician discretion.
The study will prospectively collect observational data on engraftment syndrome characteristics, laboratory parameters, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes.
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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 to Grade II-IV Acute Graft-Versus-Host Disease
大体时间：From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.
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Time from hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease among patients with engraftment syndrome.
Acute graft-versus-host disease will be graded according to institutional standard criteria.
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From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
大体时间：Up to 180 days after transplantation.
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Proportion of participants who develop grade II-IV acute graft-versus-host disease after hematopoietic stem cell transplantation.
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Up to 180 days after transplantation.
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Incidence of Chronic Graft-Versus-Host Disease
大体时间：Up to 2 years after transplantation.
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Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation.
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Up to 2 years after transplantation.
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Overall Survival
大体时间：From transplantation to death from any cause, assessed up to 2 years after transplantation.
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Time from hematopoietic stem cell transplantation to death from any cause.
Participants alive at the last follow-up will be censored.
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From transplantation to death from any cause, assessed up to 2 years after transplantation.
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Disease-Free Survival
大体时间：From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
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Time from hematopoietic stem cell transplantation to relapse, disease progression, or death from any cause, whichever occurs first.
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From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
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Cumulative Incidence of Relapse
大体时间：Up to 2 years after transplantation.
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Proportion of participants who experience relapse or disease progression after hematopoietic stem cell transplantation.
Non-relapse death will be considered a competing event in competing-risk analyses.
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Up to 2 years after transplantation.
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Non-Relapse Mortality
大体时间：Up to 2 years after transplantation.
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Death without prior relapse or disease progression after hematopoietic stem cell transplantation.
Relapse will be considered a competing event in competing-risk analyses.
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Up to 2 years after transplantation.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Severity-Oriented Engraftment Syndrome Phenotype
大体时间：From transplantation to 100 days after transplantation.
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Classification of participants into severity-oriented engraftment syndrome phenotypes based on prospectively collected engraftment kinetics, pulmonary involvement, inflammatory burden, and organ-injury markers.
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From transplantation to 100 days after transplantation.
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Association Between Engraftment Syndrome Phenotype and Grade II-IV Acute Graft-Versus-Host Disease
大体时间：Engraftment syndrome phenotype assessed up to 100 days after transplantation; grade II-IV acute graft-versus-host disease assessed up to 180 days after transplantation.
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Association between severity-oriented engraftment syndrome phenotype and subsequent development of grade II-IV acute graft-versus-host disease.
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Engraftment syndrome phenotype assessed up to 100 days after transplantation; grade II-IV acute graft-versus-host disease assessed up to 180 days after transplantation.
|
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Association Between Engraftment Syndrome Phenotype and Overall Survival
大体时间：Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
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Association between severity-oriented engraftment syndrome phenotype and overall survival after hematopoietic stem cell transplantation.
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Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
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Association Between Engraftment Syndrome Phenotype and Disease-Free Survival
大体时间：Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
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Association between severity-oriented engraftment syndrome phenotype and disease-free survival after hematopoietic stem cell transplantation.
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Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
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Performance of an Engraftment Syndrome Risk Stratification Model
大体时间：Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
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Discrimination and calibration of a risk stratification model based on engraftment syndrome-related clinical features and laboratory parameters for predicting post-transplant outcomes.
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Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
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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。
合作者
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)
2029年6月1日
研究注册日期
首次提交
2026年5月3日
首先提交符合 QC 标准的
2026年5月3日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年5月3日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- ES-HSCT-001
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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