Donor Neutrophil Subsets to Predict the Risk of aGVHD

NCT06394895 | Active Not Recruiting

• 1 other identifier: NFEC-2023-500
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Graft-versus-Host Disease

Outcome Measures

Primary Outcomes (1)

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

  100days

Secondary Outcomes (4)

• 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

Study Arms (2)

Subject-recipient (high incidence /low incidence group)

Subject-donor

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients following allogeneic hematopoietic stem cell transplantation and the corresponding donors

You may qualify if:

• Donors
• Voluntarily sign the informed consent form;
• Age 16-65 years old
• Donors whose HLA-matched or HLA-mismatched to the corresponding recipients
• Recipients
• Voluntarily sign the informed consent form
• Age 16-65 years old
• Willing to undergo HLA-matched or HLA-mismatched allo-HSCT

You may not qualify if:

• Donors
• Have a history of other tumors
• With poor compliance or mental disorders
• Infected with HIV and HCV
• With uncontrolled HBV infection
• With other autoimmune diseases
• Those who are judged by the researcher to be unsuitable to participate in this study
• Recipients
• Have a history of other tumors
• With poor compliance or mental disorders
• Infected with HIV and HCV
• With uncontrolled HBV infection
• With other autoimmune diseases
• Those who are judged by the researcher to be unsuitable to participate in this study

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Other (Non U.s.), 510000, China

Location

Study Officials

• Hua Jin

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: May 1, 2024
• Study Start: December 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: June 10, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)