Acute Graft-versus-Host Disease Clinical Trial
Official title:
Donor Neutrophil Subsets to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Verified date | April 2024 |
Source | Nanfang Hospital, Southern Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is a prospective study to explore the association between donor neutrophil subsets and acute graft-vs.-host disease outcomes. Approximately 260 subjects (including 130 donors and 130 corresponding recipients) will be recruited.
Status | Active, not recruiting |
Enrollment | 260 |
Est. completion date | June 10, 2024 |
Est. primary completion date | February 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | Inclusion Criteria: Donors 1. Voluntarily sign the informed consent form; 2. Age 16-65 years old 3. Donors whose HLA-matched or HLA-mismatched to the corresponding recipients Recipients 1. Voluntarily sign the informed consent form 2. Age 16-65 years old 3. Willing to undergo HLA-matched or HLA-mismatched allo-HSCT Exclusion Criteria: Donors 1. Have a history of other tumors 2. With poor compliance or mental disorders 3. Infected with HIV and HCV 4. With uncontrolled HBV infection 5. With other autoimmune diseases 6. Those who are judged by the researcher to be unsuitable to participate in this study Recipients 1. Have a history of other tumors 2. With poor compliance or mental disorders 3. Infected with HIV and HCV 4. With uncontrolled HBV infection 5. With other autoimmune diseases 6. Those who are judged by the researcher to be unsuitable to participate in this study |
Country | Name | City | State |
---|---|---|---|
China | Nanfang Hospital, Southern Medical University | Guangzhou | Other (Non U.s.) |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital, Southern Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes. | 100days | ||
Secondary | Association between donor neutrophil subsets and chronic GVHD (cGVHD) | 6 months | ||
Secondary | Association between donor neutrophil subsets and leukemia relapse | 6 months | ||
Secondary | Association between donor neutrophil subsets and non-relapse mortality (NRM) | 6 months | ||
Secondary | Association between donor neutrophil subsets and disease-free survival (DFS) | 6 months |
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