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.
Study Type
OBSERVATIONAL
Enrollment
250
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.
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.
Time frame: 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.
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.
Time frame: Up to 180 days after transplantation.
Incidence of Chronic Graft-Versus-Host Disease
Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years after transplantation.
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