Immune Cells in Blood and Tissues After Allogeneic Transplant and Chronic GVHD
Official title: Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation
Run by City of Hope Medical Center · NCT07235501 · Data updated 2026-11-12
This study tests whether immune cells in blood and other samples differ between people who develop chronic GVHD after an allogeneic transplant and those who don’t.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 7 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | November 1, 2026 |
| Main results expected | January 17, 2030 |
| Study ends | January 17, 2030 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07235501 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (18+) or older children (≥7 years and ≥30 kg) who have received an allogeneic hematopoietic cell transplant, with some participants diagnosed with cGVHD.
✕Probably not a fit
Patients without GVHD or with different post-transplant complications may not experience direct benefits from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study that follows adults (and some older children) who have received an allogeneic hematopoietic cell transplant. It characterizes immune cells and their subgroups in peripheral blood and collects saliva and stool samples, with medical record reviews over up to two years for some participants. Participants are placed into two cohorts: a longitudinal cohort with multiple samples and visits, and a single-collection cohort with one-time sampling. The study does not involve therapeutic interventions and relies on non-interventional procedures to explore factors related to chronic GVHD.
Why it matters
Potential benefit: If successful, the study could improve understanding of immune cell patterns associated with chronic GVHD and inform future prevention or management strategies.
How similar studies have gone: Previous research in GVHD has identified immune-cell differences, indicating this approach is grounded in prior findings, though this exact design is observational.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting
Study contacts
- Principal investigator: Ryotaro Nakamura — City of Hope Medical Center
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.