Donor Neutrophil Subsets to Predict the Risk of aGVHD

NCT ID: NCT06394895

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-06-10

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.

Conditions

Acute Graft-versus-Host Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subject-recipient (high incidence /low incidence group)

No interventions assigned to this group

Subject-donor

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hua Jin

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Other (Non U.s.), China

Countries

China

Other Identifiers

NFEC-2023-500

Identifier Type: -

Identifier Source: org_study_id