Role of aGVHD Biomarkers on aGVHD Risks (GVHD)

February 24, 2020 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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 Backup

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daihong Liu, Doctor

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

Ages Eligible for Study

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

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

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

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

Chinese PLA General Hospital

Investigators

  • 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)

July 1, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID 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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