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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07150468
Enrollment
146
Registered
2025-09-02
Start date
2021-05-13
Completion date
2025-08-20
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple Myeloma

Brief 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 strategies.

Interventions

Sampling 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

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

\- 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.

Exclusion criteria

* Patients receiving cord blood transplantation.

Design outcomes

Primary

MeasureTime frameDescription
Immune cell phenotype analysisbefore HCT and 2 weeks after HCT, 4 weeks, 3 months, 6 months, and 12 months after HCT. If GVHD occursImmune 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026