GVHD,AcuteGVHDNCT04284904
Role of aGVHD Biomarkers on aGVHD Risks
An observational study of GVHD,Acute and Biomarker, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 65 years
- Conditions the study is for
- GVHD,Acute, Biomarker
- What is being tested?
- aGVHD biomarker
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Dec 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 65 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Diagnosed with hematological diseases.
- 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.
Who cannot join
- recipients of second allogeneic stem cell transplant.
- pregnant or breast-feeding women.
- Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation.
- human immunodeficiency virus infection
- active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
- Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.
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- allergic history to Janus kinase inhibitors.
- Severe organ dysfunction unrelated
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- To establish standard risk rating criteria of aGVHD biomarkers;
- To verify the role of aGVHD biomarkers monitored in predicting aGVHD risks;
- To determine the correlation between aGVHD biomarkers monitored and aGVHD risk;
- To carry out a observative study in patients with aGVHD treatment about therapeutic protocols and medication efficacy;
- To predict the correlation between the high-risk patients with aGVHD and non-relapse mortality and disease free survival;
- Conditions
- GVHD,Acute, Biomarker
- Being tested
- aGVHD biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aGVHD biomarkerDiagnostic test
To verify the effectiveness of aGVHD biomarkers monitoring in predicting aGVHD risks
| Study group | Role | What they receive |
|---|---|---|
| matched sibling hematopoietic stem cell transplantation | aGVHD biomarker in matched sibling donor hematopoietic stem cell transplantation Receives: Diagnostic Test: aGVHD biomarker | |
| unrelated allogeneic hematopoietic stem cell transplantation | aGVHD biomarker in unrelated donor hematopoietic stem cell transplantation Receives: Diagnostic Test: aGVHD biomarker | |
| haploidentical hematopoietic stem cell transplantation | aGVHD biomarker in haploidentical donor hematopoietic stem cell transplantation Receives: Diagnostic Test: aGVHD biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 14 days after stem cell infusion
Secondary outcomes (5)
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)
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
Measured: 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
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 14 days after stem cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Feb 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHD,AcuteStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daihong Liu, Chinese PLA General Hospital
- Investigators
- Daihong Liu, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284904
- Sponsor's protocol ID
- S2019-177-02
- Acronym
- GVHD
- Status last verified
- May 2026
- First submitted
- 30 Jan 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of aGVHD Biomarkers on aGVHD Risks in Patients Underwent Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04284904
- Acronym / sponsor ID
- GVHD / S2019-177-02
- Conditions
- GVHD,Acute, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- To establish standard risk rating criteria of aGVHD biomarkers;
- To verify the role of aGVHD biomarkers monitored in predicting aGVHD risks;
- To determine the correlation between aGVHD biomarkers monitored and aGVHD risk;
- To carry out a observative study in patients with aGVHD treatment about therapeutic protocols and medication efficacy;
- To predict the correlation between the high-risk patients with aGVHD and non-relapse mortality and disease free survival;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| matched sibling hematopoietic stem cell transplantation | – | Diagnostic Test: aGVHD biomarkeraGVHD biomarker in matched sibling donor hematopoietic stem cell transplantation |
| unrelated allogeneic hematopoietic stem cell transplantation | – | Diagnostic Test: aGVHD biomarkeraGVHD biomarker in unrelated donor hematopoietic stem cell transplantation |
| haploidentical hematopoietic stem cell transplantation | – | Diagnostic Test: aGVHD biomarkeraGVHD biomarker in haploidentical donor hematopoietic stem cell transplantation |
Who may qualify
- Ages
- 0 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosed with hematological diseases.
- 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.
Key exclusion criteria (9 listed)
- recipients of second allogeneic stem cell transplant.
- pregnant or breast-feeding women.
- Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation.
- human immunodeficiency virus infection
- active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aGVHD biomarkerTo verify the effectiveness of aGVHD biomarkers monitoring in predicting aGVHD risks | Diagnostic test | haploidentical hematopoietic stem cell transplantation, matched sibling hematopoietic stem cell transplantation, unrelated allogeneic hematopoietic stem cell transplantation |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daihong Liu principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GVHD,Acute and Biomarker, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.