Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple MyelomaNCT07150468
Establishment of a Strategy for Preventing Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation by Exploring Immune Mechanisms of Regulatory and Effector T Cells
An observational study of Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple Myeloma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to explore the regulatory and effector T cell-related immune mechanisms associated with the development of graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) using patient-derived derivatives, thereby establishing the basis for GVHD prevention… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple Myeloma
- What is being tested?
- sampling blood
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2021to 20 Aug 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients and family donors undergoing allogeneic hematopoietic cell transplantation at Seoul Asan Medical Center
Who may be able to join
- 1. Patients: Patients aged 16 to 75 years receiving allogeneic hematopoietic stem cell transplantation for hematologic malignancies at Seoul Asan Medical Center.
- 2. Family members: Family members of patients under 75 years of age who meet Criterion 1 and are willing to donate peripheral blood hematopoietic stem cells.
Who cannot join
- Patients receiving cord blood transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to explore the regulatory and effector T cell-related immune mechanisms associated with the development of graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) using patient-derived derivatives, thereby establishing the basis for GVHD prevention strategies.
- Conditions
- Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple Myeloma
- Being tested
- sampling blood
- Medical subject headings
- Myelodysplastic Syndromes, Myeloproliferative Disorders, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sampling bloodOther
Sampling
- patient
- Peripheral blood samples in a volume of 25 cc will be collected before HCT and 2 weeks after HCT, and peripheral blood samples in a volume of 20 cc will be collected 4 weeks, 3 months, 6 months, and 12 months after HCT.
- If GVHD occurs, additional blood sample (20 cc) will be collected.
- In case of organ-specific GVHD including skin, gut, liver, muscle, etc., tissue samples from biopsy will be obtained for further analysis.
- donor a. Peripheral blood samples in a volume of 20 cc will be collected before HCT
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune cell phenotype analysis
Immune cell phenotypes will be analyzed by examining immunophenotypic changes in regulatory T cells and acquired immune cells using a 6-color flow cytometer. For skin and intestinal graft-versus-host disease tissues, multi-color imaging techniques (e.g., Polaris, CODEX) will be utilized to obtain spatial information and the pathogenic potential of various immune cells within the tissue.
Measured: before HCT and 2 weeks after HCT, 4 weeks, 3 months, 6 months, and 12 months after HCT. If GVHD occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start13 May 2021
- Primary completion13 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunsuk Choi, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150468
- Sponsor's protocol ID
- preventing GVHD after allo-HCT
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Strategy for Preventing Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation by Exploring Immune Mechanisms of Regulatory and Effector T Cells
- ClinicalTrials.gov ID
- NCT07150468
- Acronym / sponsor ID
- preventing GVHD after allo-HCT
- Conditions
- Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 2 Sep 2025 (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.
The purpose of this study was to explore the regulatory and effector T cell-related immune mechanisms associated with the development of graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) using patient-derived derivatives, thereby establishing the basis for GVHD prevention strategies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients and family donors undergoing allogeneic hematopoietic cell transplantation at Seoul Asan Medical Center
Key inclusion criteria (2 listed)
- 1. Patients: Patients aged 16 to 75 years receiving allogeneic hematopoietic stem cell transplantation for hematologic malignancies at Seoul Asan Medical Center.
- 2. Family members: Family members of patients under 75 years of age who meet Criterion 1 and are willing to donate peripheral blood hematopoietic stem cells.
Key exclusion criteria (1 listed)
- Patients receiving cord blood transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sampling bloodSampling 1. patient 1. Peripheral blood samples in a volume of 25 cc will be collected before HCT and 2 weeks after HCT, and peripheral blood samples in a volume of 20 cc will be collected 4 weeks, 3 months, 6 months, and 12 months after HCT. 2. If GVHD occurs, additional blood sample (20 cc) will be collected. 3. In case of organ-specific GVHD including skin, gut, liver, muscle, etc., tissue samples from biopsy will be obtained for further analysis. 2. donor a. Peripheral blood samples in a volume of 20 cc will be collected before HCT | Other | – |
Primary outcome
Immune cell phenotype analysis
Time frame: before HCT and 2 weeks after HCT, 4 weeks, 3 months, 6 months, and 12 months after HCT. If GVHD occurs
Immune cell phenotypes will be analyzed by examining immunophenotypic changes in regulatory T cells and acquired immune cells using a 6-color flow cytometer. For skin and intestinal graft-versus-host disease tissues, multi-color imaging techniques (e.g., Polaris, CODEX) will be utilized to obtain spatial information and the pathogenic potential of various immune cells within the tissue.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple Myeloma, run by Asan Medical Center at 1 site in South Korea.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Sep 2025. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immune cell phenotype analysis (time frame: before HCT and 2 weeks after HCT, 4 weeks, 3 months, 6 months, and 12 months after HCT. If GVHD occurs). 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 2 Sep 2025.