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

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.

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Key information

Conditions

Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Lymphoma, Multiple Myeloma Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Patients: Patients aged 16 to 75 years receiving allogeneic hematopoietic stem cell transplantation for hematologic malignancies at Seoul Asan Medical Center.

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.

Treatment and study plan

sampling blood

Other

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Sep 2, 2025
Registry last updated: Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed