NCT04284904

Brief 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 underwent allogeneic hematopoietic stem cell transplantation was performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

4.9 years

First QC Date

January 30, 2020

Last Update Submit

May 4, 2026

Conditions

GVHD,AcuteBiomarker

Outcome Measures

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)

    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 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)

    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

    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)

    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)

    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)

    14 days after stem cell infusion

Other Outcomes (4)

  • 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)

    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)

    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)

    7 days after aGVHD treatment

  • +1 more other outcomes

Study Arms (3)

matched sibling hematopoietic stem cell transplantation

aGVHD biomarker in matched sibling donor hematopoietic stem cell transplantation

Diagnostic Test: aGVHD biomarker

unrelated allogeneic hematopoietic stem cell transplantation

aGVHD biomarker in unrelated donor hematopoietic stem cell transplantation

Diagnostic Test: aGVHD biomarker

haploidentical hematopoietic stem cell transplantation

aGVHD biomarker in haploidentical donor hematopoietic stem cell transplantation

Diagnostic Test: aGVHD biomarker

Interventions

aGVHD biomarkerDIAGNOSTIC_TEST

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

haploidentical hematopoietic stem cell transplantationmatched sibling hematopoietic stem cell transplantationunrelated allogeneic hematopoietic stem cell transplantation

Eligibility Criteria

Age0 Years - 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Study Officials

  • Daihong Liu

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 26, 2020

Study Start

February 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 5, 2026

Record last verified: 2026-05

Locations

CN(1)