Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation (ES after HSCT)

May 3, 2026 updated by: Xiao Hui Zhang

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  1. Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center.
  2. Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria.
  3. Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters.
  4. Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes.
  5. Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.

Exclusion Criteria:

  1. Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation.
  2. Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome.
  3. Patients with missing essential follow-up information for assessment of primary outcome measures.
  4. Patients who withdraw consent or decline participation in prospective follow-up.
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients With Engraftment Syndrome
Patients who develop engraftment syndrome after hematopoietic stem cell transplantation will be enrolled and prospectively followed. Engraftment syndrome will be diagnosed according to predefined clinical criteria during the early post-transplant period. Clinical features, laboratory parameters, transplant-related characteristics, ES phenotypes, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes will be recorded and analyzed.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
Time Frame: Up to 180 days after transplantation.
Proportion of participants who develop grade II-IV acute graft-versus-host disease after hematopoietic stem cell transplantation.
Up to 180 days after transplantation.
Incidence of Chronic Graft-Versus-Host Disease
Time Frame: Up to 2 years after transplantation.
Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation.
Up to 2 years after transplantation.
Overall Survival
Time Frame: From transplantation to death from any cause, assessed up to 2 years after transplantation.
Time from hematopoietic stem cell transplantation to death from any cause. Participants alive at the last follow-up will be censored.
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.
Time from hematopoietic stem cell transplantation to relapse, disease progression, or death from any cause, whichever occurs first.
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.
Proportion of participants who experience relapse or disease progression after hematopoietic stem cell transplantation. Non-relapse death will be considered a competing event in competing-risk analyses.
Up to 2 years after transplantation.
Non-Relapse Mortality
Time Frame: Up to 2 years after transplantation.
Death without prior relapse or disease progression after hematopoietic stem cell transplantation. Relapse will be considered a competing event in competing-risk analyses.
Up to 2 years after transplantation.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity-Oriented Engraftment Syndrome Phenotype
Time Frame: From transplantation to 100 days after transplantation.
Classification of participants into severity-oriented engraftment syndrome phenotypes based on prospectively collected engraftment kinetics, pulmonary involvement, inflammatory burden, and organ-injury markers.
From transplantation to 100 days after transplantation.
Association Between Engraftment Syndrome Phenotype and 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 severity-oriented engraftment syndrome phenotype and subsequent development of grade II-IV acute graft-versus-host disease.
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
Time Frame: Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
Association between severity-oriented engraftment syndrome phenotype and overall survival after hematopoietic stem cell transplantation.
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
Time Frame: Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
Association between severity-oriented engraftment syndrome phenotype and disease-free survival after hematopoietic stem cell transplantation.
Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
Performance of an Engraftment Syndrome Risk Stratification Model
Time Frame: Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
Discrimination and calibration of a risk stratification model based on engraftment syndrome-related clinical features and laboratory parameters for predicting post-transplant outcomes.
Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiao Hui Zhang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangzhou First People's Hospital
The First Affiliated Hospital of Zhengzhou University
The Third Xiangya Hospital of Central South University
The First Hospital of Jilin University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Guangdong Provincial Hospital of Chinese Medicine, Zhuhai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ES-HSCT-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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