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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Graft-versus-Host Disease

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 Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

Study Locations

• China
  • Other (Non U.s.)
    • Guangzhou, Other (Non U.s.), China, 510000
      • Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients following allogeneic hematopoietic stem cell transplantation and the corresponding donors

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Subject-recipient (high incidence /low incidence group)
Subject-donor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Hua Jin, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: NFEC-2023-500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No