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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm; Graft Versus Host Disease; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Non-Interventional Study

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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
      • Principal Investigator: Ryotaro Nakamura
      • Contact: Ryotaro Nakamura; Phone Number: 626-218-2405; Email: rnakamura@coh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have received allogeneic hematopoietic cell transplant.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T cell measurements	Defined as percentage of naïve and memory T cells using high dimensional flow cytometry.	Up to 2 years - study completion
B cell measurements	Defined as percentage of naïve B, memory B, and plasma cells using high dimensional flow cytometry.	Up to 2 years - study completion
Macrophage measurements	Defined as percentage of M1, M2, and M0 using high dimensional flow cytometry.	Up to 2 years - study completion

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ryotaro Nakamura, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 11, 2028
• Study Completion (Estimated): April 11, 2028

Study Registration Dates

• First Submitted: November 10, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: 24871 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2025-04424 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01HL170099 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No