Role of aGVHD Biomarkers on aGVHD Risks

NCT ID: NCT04284904

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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;

Conditions

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GVHD,Acute Biomarker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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matched sibling hematopoietic stem cell transplantation

aGVHD biomarker in matched sibling donor hematopoietic stem cell transplantation

aGVHD biomarker

Intervention Type DIAGNOSTIC_TEST

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

aGVHD biomarker

Intervention Type DIAGNOSTIC_TEST

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

aGVHD biomarker

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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aGVHD biomarker

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daihong Liu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daihong Liu

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liping Dou

Role: CONTACT

86-13681207138

Mingyu Jia

Role: CONTACT

86-15210723049

Facility Contacts

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Daihong Liu, doctor

Role: primary

86-13681171597

Liping Dou, doctor

Role: backup

86-13681207138

Other Identifiers

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S2019-177-02

Identifier Type: -

Identifier Source: org_study_id

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