Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem C… (NCT07577375) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation
250 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
SexALL
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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.
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What they're measuring
1
Time to Grade II-IV Acute Graft-Versus-Host Disease
Timeframe: 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.
. 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.