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.

• Non-Interventional Study (Other), also known as Non-Interventional Observational Study, Noninterventional (Observational) Study: Non-interventional study

Primary outcomes

• T cell measurements [Up to 2 years - study completion]: Defined as percentage of naïve and memory T cells using high dimensional flow cytometry.
• B cell measurements [Up to 2 years - study completion]: Defined as percentage of naïve B, memory B, and plasma cells using high dimensional flow cytometry.
• Macrophage measurements [Up to 2 years - study completion]: Defined as percentage of M1, M2, and M0 using high dimensional flow cytometry.

Sex: All, ages: 7 Years to any

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

• Ryotaro Nakamura, Principal investigator, City of Hope Medical Center

NIH grants: P30CA033572, R01HL170099