Donor Neutrophil Subsets to Predict the Risk of aGVHD

Donor Neutrophil Subsets to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06394895

Enrollment

260

Registered

2024-05-01

Start date

2023-12-01

Completion date

2024-06-10

Last updated

2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Graft-versus-Host Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Association between donor neutrophil subsets and chronic GVHD (cGVHD)	6 months
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

Countries

China

Outcome results