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NCT07235501Recruiting

Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation

City of Hope Medical Center

Start Date

10/1/2026

Completion Date

1/17/2030

Summary

This study evaluates the factors that contribute to chronic graft-versus-host disease, which is a complication that can occur after allogeneic hematopoietic cell transplantation.

Detailed Description

PRIMARY OBJECTIVE: I. Characterize immune cells and their subsets in peripheral blood of patients who develop and do not develop chronic graft-versus-host disease (cGVHD). OUTLINE: This is an observational study. Patients are assigned to 1 of 2 cohorts. COHORT 1: Patients undergo blood, saliva/buccal, and stool sample collection for up to 2 years on study. Patients also have their medical records reviewed on study. COHORT 2: Patients undergo a one-time blood, saliva/buccal, and stool sample collection and have their medical records reviewed on study.

Eligibility Criteria

Age Range: 7 years to No maximum

Inclusion Criteria: * \* BOTH COHORTS: * Documented written informed consent of the participant and/or parent/guardian. * Assent from pediatric participants will be documented per institutional policies and practice. * Patients who have received allogeneic hematopoietic cell transplant (HCT) regardless of donor type, condition regimen, or GVHD prophylaxis. * Age: ≥ 18 years or ≥ 7 years if 30 kg and above * Willingness to: * Provide blood sample(s), stool, saliva, and buccal mucosa, * If applicable: Permit medical record/ clinical laboratory result review * COHORT 1: * Patients who have received allogeneic hematopoietic cell transplant (HCT) regardless of donor type, condition regimen, or GVHD prophylaxis. * COHORT 2: * Patients diagnosed with cGVHD at any time-point after allogeneic HCT regardless of donor type, condition regimen, or GVHD prophylaxis. Exclusion Criteria: * \* Women of childbearing potential: Pregnant/nursing * Individuals with impaired decision-making capacity * An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager * A direct study team member

Interventions

OTHER

Non-Interventional Study

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Conditions

Graft Versus Host DiseaseHematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Locations

City of Hope Medical Center

Duarte, California 91010

United States