Donor Neutrophil Subsets to Predict the Risk of aGVHD

Acute Graft-versus-Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06394895
• Other study ID #: NFEC-2023-500
• Status: Active, not recruiting
• Start date: December 1, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: April 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: June 10, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Graft-versus-Host Disease
• Graft vs Host Disease

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.		100days
Secondary	Association between donor neutrophil subsets and chronic GVHD (cGVHD)		6 months
Secondary	Association between donor neutrophil subsets and leukemia relapse		6 months
Secondary	Association between donor neutrophil subsets and non-relapse mortality (NRM)		6 months
Secondary	Association between donor neutrophil subsets and disease-free survival (DFS)		6 months