Donor Neutrophil Subsets to Predict the Risk of aGVHD

Active, not recruiting

• Conditions: Acute Graft-versus-Host Disease

• Registration Number: NCT06394895
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2023.12 to 2024.3, the clinical enrollment was completed, and from 2024.3 to 2024.6, the follow-up was completed. It is planned to enroll 260 subjects, divided into 130 donors and 130 patients.

No randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate.

All recipients will be followed for aGVHD evaluation, relapse, cGVHD, leukemia relapse, disease-free survival (DFS), non-relapse mortality (NRM). aGVHD and cGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed.

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2023-12-20
• Primary Completion: 2024-02-29
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Study Completion: 2024-06-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.	100days

Secondary Outcome Measures

Name	Time	Method
Association between donor neutrophil subsets and leukemia relapse	6 months
Association between donor neutrophil subsets and non-relapse mortality (NRM)	6 months
Association between donor neutrophil subsets and disease-free survival (DFS)	6 months
Association between donor neutrophil subsets and chronic GVHD (cGVHD)	6 months

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Other (Non U.s.), China