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

NCT07235501 | Not Yet Recruiting DMC

• 4 other identifiers: 24871NCI-2025-04424P30CA033572R01HL170099
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Non-Interventional Study OTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

Observational Cohort 1; Observational Cohort 2

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have received allogeneic hematopoietic cell transplant.

You may qualify if:

• \* 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.

You may not qualify if:

• \* 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Ryotaro Nakamura

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 19, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 11, 2028
• Study Completion (Estimated): April 11, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)