Role of aGVHD Biomarkers on aGVHD Risks (GVHD)

May 4, 2026 updated by: Daihong Liu, Chinese PLA General Hospital

Role of aGVHD Biomarkers on aGVHD Risks in Patients Underwent Hematopoietic Stem Cell Transplantation

To establish risk rating criteria of biological protein marker, determine the role and consistency of aGVHD biomarkers in aGVHD diagnosis and aGVHD prognosis, and evaluate the the impact on non-relapse mortality and relapse and disease free survival, the multicenter study on aGVHD biomarkers detection in the patients underwent allogeneic hematopoietic stem cell transplantation was performed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

  1. To establish standard risk rating criteria of aGVHD biomarkers;
  2. To verify the role of aGVHD biomarkers monitored in predicting aGVHD risks;
  3. To determine the correlation between aGVHD biomarkers monitored and aGVHD risk;
  4. To carry out a observative study in patients with aGVHD treatment about therapeutic protocols and medication efficacy;
  5. To predict the correlation between the high-risk patients with aGVHD and non-relapse mortality and disease free survival;

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 (Actual)

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.
500

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.

Study Contact Backup

  • Name: Mingyu Jia
  • Phone Number: 86-15210723049

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Chinese PLA General Hospital

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

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Diagnosed with hematological diseases and nderwent first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.

Description

Inclusion Criteria:

  1. Diagnosed with hematological diseases.
  2. Have underwent first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.

Exclusion Criteria:

  1. recipients of second allogeneic stem cell transplant.
  2. pregnant or breast-feeding women.
  3. Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation.
  4. human immunodeficiency virus infection
  5. active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
  6. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.
  7. allergic history to Janus kinase inhibitors.
  8. Severe organ dysfunction unrelated
  9. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
matched sibling hematopoietic stem cell transplantation
aGVHD biomarker in matched sibling donor hematopoietic stem cell transplantation
Diagnostic test: aGVHD biomarker
To verify the effectiveness of aGVHD biomarkers monitoring in predicting aGVHD risks
unrelated allogeneic hematopoietic stem cell transplantation
aGVHD biomarker in unrelated donor hematopoietic stem cell transplantation
Diagnostic test: aGVHD biomarker
To verify the effectiveness of aGVHD biomarkers monitoring in predicting aGVHD risks
haploidentical hematopoietic stem cell transplantation
aGVHD biomarker in haploidentical donor hematopoietic stem cell transplantation
Diagnostic test: aGVHD biomarker
To verify the effectiveness of aGVHD biomarkers monitoring in predicting aGVHD risks

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
The correlation between cumulative incidence of aGVHD relapse at 3 months after transplantation with aGVHD biomarkers monitored (serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 14 days after stem cell infusion
For all cytokines/biomarkers (serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)) that are measured by flow cytometry repeatedly over time(every two week until three months after transplantation), a nonparametric smoothing plot will be produced in the first step to view changes in the trend. Expression level changes on the onset of aGVHD from baseline measures will be correlated with aGVHD relapse at 3 months after transplantation.
14 days after stem cell infusion

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
The correlation between cumulative incidence of cGVHD relapse at 24 months after transplantation with aGVHD biomarkers monitored(serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 14 days after stem cell infusion
For all cytokines/biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) that are measured repeatedly over time (every two week until three months after transplantation), a nonparametric smoothing plot will be produced in the first step to view changes in the trend. Expression level changes on the onset of aGVHD from baseline measures will be correlated with cGVHD relapse at 24 months after transplantation
14 days after stem cell infusion
The correlation between cumulative incidence of relapsed aGVHD grade at 3 months after transplantation with aGVHD biomarkers monitored(serum concentration of REG3a; ST22; IL-6; IL-8;TNF R1
Time Frame: 14 days after stem cell infusion
For all cytokines/biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) that are measured repeatedly over time (every two week until three months after transplantation), a nonparametric smoothing plot will be produced in the first step to view changes in the trend. Expression level changes on the onset of aGVHD from baseline measures will be correlated with relapsed aGVHD grade (1, 2, 3, 4) at 3 months after transplantation
14 days after stem cell infusion
The correlation between overall survival with aGVHD biomarkers monitored(serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 14 days after stem cell infusion
Expression level changes of aGVHD biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) on the onset of aGVHD from baseline measures will be correlated with overall survival
14 days after stem cell infusion
The correlation between relapse free survival with aGVHD biomarkers monitored(serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 14 days after stem cell infusion
Expression level changes of aGVHD biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) on the onset of aGVHD from baseline measures will be correlated with relapse free survival
14 days after stem cell infusion
The correlation between non relapse mortality with aGVHD biomarkers monitored(serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 14 days after stem cell infusion
Expression level changes of aGVHD biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) on the onset of aGVHD from baseline measures will be correlated with non relapse mortality
14 days after stem cell infusion

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
The correlation between cumulative incidence of aGVHD relapse at 3 months after transplantation with aGVHD biomarkers monitored(serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 7 days after aGVHD treatment
For all cytokines/biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) that are measured repeatedly over time (every two week until three months after transplantation), a nonparametric smoothing plot will be produced in the first step to view changes in the trend. Expression level changes 7 days after aGVHD treatment from baseline measures will be correlated with aGVHD relapse at 3 months after transplantation
7 days after aGVHD treatment
The correlation between cumulative incidence of cGVHD relapse at 24 months after transplantation with aGVHD biomarkers monitored(serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 7 days after aGVHD treatment
For all cytokines/biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) that are measured repeatedly over time (every two week until three months after transplantation), a nonparametric smoothing plot will be produced in the first step to view changes in the trend. Expression level changes 7 days after aGVHD treatment from baseline measures will be correlated with cGVHD relapse at 24 months after transplantation
7 days after aGVHD treatment
The correlation between overall survival with aGVHD biomarkers monitored(serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 7 days after aGVHD treatment
Expression level changes of aGVHD biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) 7 days after aGVHD treatment from baseline measures will be correlated with overall survival
7 days after aGVHD treatment
The correlation between non relapse mortality with aGVHD biomarkers monitored(serum concentration of REG3: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R)
Time Frame: 7 days after aGVHD treatment
Expression level changes of aGVHD biomarkers (serum concentration of REG3a: regenerating islet-derived-3-a; ST2: suppression of tumorigenicity 2; IL-6; IL-8; TNF R) 7 days after aGVHD treatment from baseline measures will be correlated with non relapse mortality
7 days after aGVHD treatment

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.
Chinese PLA General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daihong Liu, Chinese PLA General Hospital

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 (Actual)

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.
February 1, 2019

Primary Completion (Actual)

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.
December 31, 2023

Study Completion (Actual)

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.
December 31, 2023

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).
January 30, 2020

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.
February 24, 2020

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.
February 26, 2020

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 5, 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 4, 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

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.
  • S2019-177-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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