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Completed

NCT Number: NCT04284904

Role of aGVHD Biomarkers on aGVHD Risks

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.

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Key information

Conditions

GVHD,Acute Biomarker

Age range

0 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

  • 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;

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

aGVHD biomarker

Diagnostic Test

To verify the effectiveness of aGVHD biomarkers monitoring in predicting aGVHD risks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Acronym: GVHD

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2020
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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