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

NCT07150468 | Completed DMC

• 1 other identifier: preventing GVHD after allo-HCT
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  before HCT and 2 weeks after HCT, 4 weeks, 3 months, 6 months, and 12 months after HCT. If GVHD occurs

Interventions

sampling blood OTHER

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

Eligibility Criteria

• Age: 16 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients and family donors undergoing allogeneic hematopoietic cell transplantation at Seoul Asan Medical Center

You may qualify if:

• \- 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.

You may not qualify if:

• Patients receiving cord blood transplantation.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Myeloproliferative Disorders; Lymphoma; Multiple Myeloma

Interventions

Cordocentesis

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: May 13, 2021
• Primary Completion: August 13, 2025
• Study Completion: August 20, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

KR (1)