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

ConditionsEngraftment Syndrome Allo-HSCT

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

This trial does not accept healthy volunteers

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 population

The study population will include patients who develop engraftment syndrome after allogeneic hematopoietic stem cell transplantation at the participating center. Patients will be prospectively enrolled after the diagnosis of engraftment syndrome and followed for subsequent grade II-IV acute graft-versus-host disease and post-transplant outcomes, including overall survival, disease-free survival, relapse, and non-relapse mortality. Clinical features, laboratory parameters, engraftment kinetics, and organ-injury markers related to engraftment syndrome will be collected to validate ES phenotypes and their prognostic significance.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

No Intervention: Observational Cohort
Other intervention
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.

Treatment groups

250 Participants

are divided into 1 treatment group

Group A: Patients With Engraftment Syndrome1 intervention

Trial outcomes

Primary 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.

Secondary outcomes

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.

Other outcomes

Severity-Oriented Engraftment Syndrome Phenotype

Classification of participants into severity-oriented engraftment syndrome phenotypes based on prospectively collected engraftment kinetics, pulmonary involvement, inflammatory burden, and organ-injury markers.

Time frame

From transplantation to 100 days after transplantation.

Association Between Engraftment Syndrome Phenotype and Grade II-IV Acute Graft-Versus-Host Disease

Association between severity-oriented engraftment syndrome phenotype and subsequent development of grade II-IV acute graft-versus-host disease.

Time frame

Engraftment syndrome phenotype assessed up to 100 days after transplantation; grade II-IV acute graft-versus-host disease assessed up to 180 days after transplantation.

Association Between Engraftment Syndrome Phenotype and Overall Survival

Association between severity-oriented engraftment syndrome phenotype and overall survival after hematopoietic stem cell transplantation.

Time frame

Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.

Association Between Engraftment Syndrome Phenotype and Disease-Free Survival

Association between severity-oriented engraftment syndrome phenotype and disease-free survival after hematopoietic stem cell transplantation.

Time frame

Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

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