Recruiting

Chronic Graft-Versus-Host Disease

Sponsor:

City of Hope Medical Center

Code:

NCT07235501

Conditions

Graft Versus Host Disease

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

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

Study ID

NCT07235501

Start date

Nov 1, 2026

Status verified date

Sep, 2026

Completion date

Jan 17, 2030

Anticipated

Primary completion date

Jan 17, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

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

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Observational Cohort 2

Patients undergo a one-time blood, saliva/buccal, and stool sample collection and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • T cell measurements [ Time Frame: Up to 2 years - study completion ]
  • B cell measurements [ Time Frame: Up to 2 years - study completion ]
  • Macrophage measurements [ Time Frame: Up to 2 years - study completion ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Ryotaro Nakamura

626-218-2405rnakamura@coh.org

Principal Investigator:

Ryotaro Nakamura

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.