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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

* 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 population

Patients who have received allogeneic hematopoietic cell transplant.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Observational Cohort 11 intervention
Group B: Observational Cohort 21 intervention

Trial outcomes

Primary outcomes

1

T cell measurements

Defined as percentage of naïve and memory T cells using high dimensional flow cytometry.

Time frame
Up to 2 years - study completion
2

B cell measurements

Defined as percentage of naïve B, memory B, and plasma cells using high dimensional flow cytometry.

Time frame
Up to 2 years - study completion
3

Macrophage measurements

Defined as percentage of M1, M2, and M0 using high dimensional flow cytometry.

Time frame
Up to 2 years - study completion

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator