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Recruiting NCT07235501

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

— Observational Graft Versus Host Disease Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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:

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.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • City of Hope Medical Center — Duarte

Identifiers

NCT: NCT07235501 · 24871 · NCI-2025-04424 · 24871 · P30CA033572 · R01HL170099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗