Allo-HSCT, Engraftment Syndrome
Conditions
Keywords
Engraftment Syndrome, allo-HSCT, acute GVHD
Brief summary
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.
Interventions
OTHERNo Intervention: Observational Cohort
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.
Sponsors
Xiao Hui Zhang
Guangdong Provincial Hospital of Chinese Medicine, Zhuhai
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Zhengzhou University
The Third Xiangya Hospital of Central South University
The First Hospital of Jilin University
Guangzhou First People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
1. Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center. 2. Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria. 3. Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters. 4. Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes. 5. Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.
Exclusion criteria
1. Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation. 2. Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome. 3. Patients with missing essential follow-up information for assessment of primary outcome measures. 4. Patients who withdraw consent or decline participation in prospective follow-up. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Grade II-IV Acute Graft-Versus-Host Disease | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade II-IV Acute Graft-Versus-Host Disease | Up to 180 days after transplantation. | Proportion of participants who develop grade II-IV acute graft-versus-host disease after hematopoietic stem cell transplantation. |
| Incidence of Chronic Graft-Versus-Host Disease | Up to 2 years after transplantation. | Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation. |
| Overall Survival | From transplantation to death from any cause, assessed up to 2 years after transplantation. | Time from hematopoietic stem cell transplantation to death from any cause. Participants alive at the last follow-up will be censored. |
| Disease-Free Survival | From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation. | Time from hematopoietic stem cell transplantation to relapse, disease progression, or death from any cause, whichever occurs first. |
| Cumulative Incidence of Relapse | Up to 2 years after transplantation. | 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. |
| Non-Relapse Mortality | Up to 2 years after transplantation. | Death without prior relapse or disease progression after hematopoietic stem cell transplantation. Relapse will be considered a competing event in competing-risk analyses. |
Contacts
CONTACTYejun Wu
Outcome results
None listed