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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXiao Hui Zhang

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • No Intervention: Observational Cohort

Treatment groups

250 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Xiao Hui Zhang

Lead sponsor

Peking University People's Hospital

Sponsor institution

Guangdong Provincial Hospital of Chinese Medicine, Zhuhai

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

The Third Xiangya Hospital of Central South University

Collaborator

The First Hospital of Jilin University

Collaborator

Guangzhou First People's Hospital

Collaborator