Acute Graft-versus-Host DiseaseNCT06394895
Donor Neutrophil Subsets to Predict the Risk of aGVHD
An observational study of Acute Graft-versus-Host Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Acute Graft-versus-Host Disease
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 10 Jun 2024
- How long will I take part?
- 100 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients following allogeneic hematopoietic stem cell transplantation and the corresponding donors
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Other (Non U.s.), 510000
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Graft-versus-Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subject-recipient (high incidence /low incidence group) | Not described | |
| Subject-donor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.
Measured: 100days
Secondary outcomes (4)
Association between donor neutrophil subsets and chronic GVHD (cGVHD)
Measured: 6 months
Association between donor neutrophil subsets and leukemia relapse
Measured: 6 months
Association between donor neutrophil subsets and non-relapse mortality (NRM)
Measured: 6 months
Association between donor neutrophil subsets and disease-free survival (DFS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Dec 2023
- Primary completion29 Feb 2024
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
- Target duration
- 100 Days
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hua Jin, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394895
- Sponsor's protocol ID
- NFEC-2023-500
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor Neutrophil Subsets to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06394895
- Acronym / sponsor ID
- NFEC-2023-500
- Conditions
- Acute Graft-versus-Host Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subject-recipient (high incidence /low incidence group) | – | – |
| Subject-donor | – | – |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients following allogeneic hematopoietic stem cell transplantation and the corresponding donors
Key inclusion criteria (8 listed)
- Donors
- Voluntarily sign the informed consent form;
- Age 16-65 years old
- Donors whose HLA-matched or HLA-mismatched to the corresponding recipients
- Recipients
Key exclusion criteria (14 listed)
- Donors
- Have a history of other tumors
- With poor compliance or mental disorders
- Infected with HIV and HCV
- With uncontrolled HBV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.
Time frame: 100days
4 secondary outcomes
Association between donor neutrophil subsets and chronic GVHD (cGVHD)
Time frame: 6 months
Association between donor neutrophil subsets and leukemia relapse
Time frame: 6 months
Association between donor neutrophil subsets and non-relapse mortality (NRM)
Time frame: 6 months
Association between donor neutrophil subsets and disease-free survival (DFS)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Jin principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Graft-versus-Host Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes. (time frame: 100days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.