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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-27

Study Completion Date

2028-04-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Non-Interventional Study

Intervention Type 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.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Other Intervention Names

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Non-Interventional Observational Study Noninterventional (Observational) Study

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No