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Not yet recruiting NCT07577375

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

— Observational Engraftment Syndrome Allo-HSCT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Engraftment Syndrome, Allo-HSCT. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Observational Cohort Study to Validate Engraftment Syndrome Phenotypes and Their Associations With Acute Graft-Versus-Host Disease and Clinical Outcomes After Hematopoietic Stem Cell Transplantation

Overview

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

  • Other No 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.

Primary outcome measures

  • Time to Grade II-IV Acute Graft-Versus-Host Disease [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.]
Secondary outcome measures (6)
  • Incidence of Grade II-IV Acute Graft-Versus-Host Disease [Time frame: Up to 180 days after transplantation.]
  • Incidence of Chronic Graft-Versus-Host Disease [Time frame: Up to 2 years after transplantation.]
  • Overall Survival [Time frame: From transplantation to death from any cause, assessed up to 2 years after transplantation.]
  • Disease-Free Survival [Time frame: From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.]
  • Cumulative Incidence of Relapse [Time frame: Up to 2 years after transplantation.]
  • Non-Relapse Mortality [Time frame: Up to 2 years after transplantation.]

Eligibility criteria

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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07577375 · ES-HSCT-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗