Clinical trial NCT06394895: Donor Neutrophil Subsets to Predict the Risk of aGVHD
Official title: Donor Neutrophil Subsets to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Graft-versus-Host Disease
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 260
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients following allogeneic hematopoietic stem cell transplantation and the corresponding donors

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.
timeFrame: 100days
Secondary outcomes:
measure: Association between donor neutrophil subsets and chronic GVHD (cGVHD)
timeFrame: 6 months
measure: Association between donor neutrophil subsets and leukemia relapse
timeFrame: 6 months
measure: Association between donor neutrophil subsets and non-relapse mortality (NRM)
timeFrame: 6 months
measure: Association between donor neutrophil subsets and disease-free survival (DFS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Other (Non U.s.)
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Hua Jin
role: PRINCIPAL_INVESTIGATOR
References: