Donor Neutrophil Subsets to Predict the Risk of aGVHD

N/AActive Not RecruitingNCT06394895

Nanfang Hospital, Southern Medical University260 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

260

Conditions

Acute Graft-versus-Host Disease

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Nanfang Hospital, Southern Medical University

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

Outcomes

Primary Outcomes

Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.

Time frame: 100days

Secondary Outcomes

Association between donor neutrophil subsets and chronic GVHD (cGVHD)

Time frame: 6 months

Association between donor neutrophil subsets and leukemia relapse

Time frame: 6 months

Association between donor neutrophil subsets and non-relapse mortality (NRM)

Time frame: 6 months

Association between donor neutrophil subsets and disease-free survival (DFS)

Time frame: 6 months

Data from ClinicalTrials.gov

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