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| Name | Class |
|---|---|
| Guangdong Provincial Hospital of Chinese Medicine, Zhuhai | UNKNOWN |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| The First Affiliated Hospital of Zhengzhou University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Grade II-IV Acute Graft-Versus-Host Disease | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade II-IV Acute Graft-Versus-Host Disease | Proportion of participants who develop grade II-IV acute graft-versus-host disease after hematopoietic stem cell transplantation. | Up to 180 days after transplantation. |
| Incidence of Chronic Graft-Versus-Host Disease |
| Measure | Description | Time Frame |
|---|---|---|
| Severity-Oriented Engraftment Syndrome Phenotype | Classification of participants into severity-oriented engraftment syndrome phenotypes based on prospectively collected engraftment kinetics, pulmonary involvement, inflammatory burden, and organ-injury markers. | From transplantation to 100 days after transplantation. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yejun Wu | Contact | +8618800181620 | wyejun1999@163.com |
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| The Third Xiangya Hospital of Central South University | OTHER |
| The First Hospital of Jilin University | OTHER |
| Guangzhou First People's Hospital | OTHER |
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Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation. |
| Up to 2 years after transplantation. |
| Overall Survival | Time from hematopoietic stem cell transplantation to death from any cause. Participants alive at the last follow-up will be censored. | From transplantation to death from any cause, assessed up to 2 years after transplantation. |
| Disease-Free Survival | Time from hematopoietic stem cell transplantation to relapse, disease progression, or death from any cause, whichever occurs first. | From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation. |
| Cumulative Incidence of Relapse | 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. | Up to 2 years after transplantation. |
| Non-Relapse Mortality | Death without prior relapse or disease progression after hematopoietic stem cell transplantation. Relapse will be considered a competing event in competing-risk analyses. | Up to 2 years after transplantation. |
| Association Between Engraftment Syndrome Phenotype and Grade II-IV Acute Graft-Versus-Host Disease |
Association between severity-oriented engraftment syndrome phenotype and subsequent development of grade II-IV acute graft-versus-host disease. |
| 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. |
| Association Between Engraftment Syndrome Phenotype and Overall Survival | Association between severity-oriented engraftment syndrome phenotype and overall survival after hematopoietic stem cell transplantation. | Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation. |
| Association Between Engraftment Syndrome Phenotype and Disease-Free Survival | Association between severity-oriented engraftment syndrome phenotype and disease-free survival after hematopoietic stem cell transplantation. | Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation. |
| Performance of an Engraftment Syndrome Risk Stratification Model | Discrimination and calibration of a risk stratification model based on engraftment syndrome-related clinical features and laboratory parameters for predicting post-transplant outcomes. | Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation. |