Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation

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Conditions studied: Engraftment Syndrome, Allo-HSCT

In brief

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.

Key facts

Study ID

NCT07577375

Run by

Xiao Hui Zhang

People needed

250

Starts

2026-06-01

Expected to finish

2029-06-01

Last updated by the study team

2026-05-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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