Clinical trial NCT04284904: Role of aGVHD Biomarkers on aGVHD Risks
Official title: Role of aGVHD Biomarkers on aGVHD Risks in Patients Underwent Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GVHD,Acute
Biomarker
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 500
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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;

Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: 14 days after stem cell infusion
Secondary outcomes:
measure: 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)
timeFrame: 14 days after stem cell infusion
measure: 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
timeFrame: 14 days after stem cell infusion
measure: 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)
timeFrame: 14 days after stem cell infusion
measure: 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)
timeFrame: 14 days after stem cell infusion
measure: 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)
timeFrame: 14 days after stem cell infusion
Other outcomes:
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)
timeFrame: 7 days after aGVHD treatment
measure: 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)
timeFrame: 7 days after aGVHD treatment
measure: 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)
timeFrame: 7 days after aGVHD treatment
measure: 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)
timeFrame: 7 days after aGVHD treatment
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Daihong Liu
role: PRINCIPAL_INVESTIGATOR
References: