Graft Versus Host DiseaseNCT07235501
Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation
An observational study of Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 17 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have received allogeneic hematopoietic cell transplant.
Who may be able to join
- * 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:
Show all 12Show fewer
- 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.
Who cannot join
- * 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Ryotaro Nakamura, 626-218-2405, rnakamura@coh.org
Ryotaro Nakamura
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Non-Interventional Study
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study | |
| Observational Cohort 2 | Patients undergo a one-time blood, saliva/buccal, and stool sample collection and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell measurements
Defined as percentage of naïve and memory T cells using high dimensional flow cytometry.
Measured: 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.
Measured: Up to 2 years - study completion
Macrophage measurements
Defined as percentage of M1, M2, and M0 using high dimensional flow cytometry.
Measured: Up to 2 years - study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Nov 2026 (estimated)
- Primary completion17 Jan 2030 (estimated)
- Study completion17 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryotaro Nakamura, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235501
- Sponsor's protocol ID
- 24871
- Other IDs
- NCI-2025-04424, 24871, P30CA033572, R01HL170099
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT07235501
- Acronym / sponsor ID
- 24871
- Conditions
- Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 17 Jan 2030 (estimated)
- Study completion
- 17 Jan 2030 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort 1 | – | Other: Non-Interventional StudyPatients 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 | – | Other: Non-Interventional StudyPatients undergo a one-time blood, saliva/buccal, and stool sample collection and have their medical records reviewed on study. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have received allogeneic hematopoietic cell transplant.
Key inclusion criteria (12 listed)
- * BOTH COHORTS:
Key exclusion criteria (4 listed)
- * Women of childbearing potential: Pregnant/nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational Cohort 1, Observational Cohort 2 |
Primary outcome
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.
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.
Macrophage measurements
Time frame: Up to 2 years - study completion
Defined as percentage of M1, M2, and M0 using high dimensional flow cytometry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryotaro Nakamura principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T cell measurements (time frame: Up to 2 years - study completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.