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

August 25, 2026 updated by: City of Hope Medical Center
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
        • Principal Investigator:
          • Ryotaro Nakamura
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ryotaro Nakamura, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

January 17, 2030

Study Completion (Estimated)

January 17, 2030

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)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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