Role of aGVHD Biomarkers on aGVHD Risks

Chinese PLA General Hospital (301 Hospital)

Status

Unknown

Conditions

Biomarker

GVHD,Acute

Treatments

Diagnostic Test: aGVHD biomarker

Study type

Observational

Funder types

Other

Identifiers

NCT04284904

S2019-177-02

Details and patient eligibility

About

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.

Full 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;

Enrollment

500 estimated patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

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.