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

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.

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