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

Purpose

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.

Conditions

  • Graft Versus Host Disease
  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility

Eligible Ages
Over 7 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Observational 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.
  • Other: Non-Interventional Study
    Non-interventional study
    Other names:
    • Non-Interventional Observational Study
    • Noninterventional (Observational) Study
Observational Cohort 2 Patients undergo a one-time blood, saliva/buccal, and stool sample collection and have their medical records reviewed on study.
  • Other: Non-Interventional Study
    Non-interventional study
    Other names:
    • Non-Interventional Observational Study
    • Noninterventional (Observational) Study

Recruiting Locations

City of Hope Medical Center
Duarte, California 91010
Contact:
Ryotaro Nakamura
626-218-2405
rnakamura@coh.org

More Details

Status
Recruiting
Sponsor
City of Hope Medical Center

Study Contact

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.