T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant

November 14, 2019 updated by: Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center

Regulatory T Cells at Engraftment as Predictors of Acute Graft-Versus-Host Disease Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict whether patients undergoing donor stem cell transplant will develop acute graft-versus-host disease.

PURPOSE: This clinical trial is studying T cells to see how well they help in predicting acute graft-versus-host disease in patients undergoing donor stem cell transplant.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To determine the association between regulatory T-lymphocyte (Treg) subsets present at engraftment and at day 28 with the incidence of acute graft-versus-host-disease (aGVHD) in patients undergoing allogeneic stem cell transplantation.
  • To identify gut-homing and skin-homing Treg subsets and determine their role during engraftment and at day 28 as a predictor of gut and skin aGVHD, respectively.

OUTLINE: Patients undergo blood sample collection at the time of neutrophil engraftment prior to stem cell transplant (SCT) and post-SCT on days 7, 14, 21, and 28 days after allogeneic stem cell transplantation. Blood samples are analyzed for T-cell subsets and for the percentage of regulatory T-lymphocyte (Treg) or other T-cell subsets expressing specific homing receptors for the gut or skin via flow cytometry.

Patients' medical records are also reviewed periodically.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People with a disease which is being treated with a bone marrow and/or a stem cell transplant.

Description

Inclusion criteria:

  • Patients undergoing allogeneic SCT
  • Age >= 18 years

Exclusion criteria:

  • Inability to give informed consent
  • Patients who have not received an allogeneic SCT
  • Any condition which, in the opinion of the investigator, might interfere with study objective
  • Any reason which, in the opinion of the investigator, adds additional risk to the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Allogeneic Stem Cell Transplant Patients
Patients undergoing allogeneic stem cell transplant (SCT). Potential study candidates will be identified by participating physicians.
Other: flow cytometry
Lymphocyte Analysis: Lymphocyte subset studies will be performed on samples obtained from the patient, donor, or graft. Aliquots will be analyzed using standard flow cytometry.
Other: laboratory biomarker analysis
Identification of gut-homing and skin-homing Treg subsets
Other: Data Collection
Patient samples will receive an alphanumeric code assigned by the principal investigator so that patient and donor identity will be known only to study investigators and research staff. Clinical records on each patient will be reviewed by participating investigators or research staff on a routine basis so that relevant clinical information including survival, malignancy relapse, and GVHD can be included in the patient database. Flow cytometry results will also be included in this database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of regulatory T-lymphocytes (Tregs) at engraftment
Time Frame: day of stem cell transplant
percentage of Treg subsets present in patient's blood before they undergo stem cell transplant
day of stem cell transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Treg subsets and acute graft-vs.-host disease outcomes
Time Frame: at stem cell transplant and at day 28
Identify gut homing and skin homing Treg lymphocyte subsets and compare and contrast them to determine links between the Treg subsets and gut and/or skin acute graft-vs.-host-disease incidence, stage/grade, target organ involvement, and responsiveness to therapy.
at stem cell transplant and at day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC BMT 0653
  • P30CA068485 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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