Lymphocyte Profiles and Activation Status in Patients With Graft-Versus-Host Disease

February 26, 2015 updated by: Samantha Jaglowski, Ohio State University Comprehensive Cancer Center

Lymphocyte Profiles and Activation Status in the Development of Chronic Graft-versus-Host Disease

This research trial studies lymphocyte profiles and activation status in patients with graft-versus-host disease. Studying samples of blood in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to graft-versus-host disease.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To explore and assess changes in subsets and activation status of B-, T,-, and natural killer (NK) lymphocytes in peripheral blood following allogeneic stem cell transplant and how they may be associated with clinical events with an ultimate future goal of conducting a larger successor study to identify potential therapeutic targets based on its findings.

SECONDARY OBJECTIVES:

I. To assess the feasibility of obtaining and comparing patients with chronic graft-versus-host disease (cGVHD) with time-matched stem cell transplant (SCT) patients without cGVHD and identify logistical challenges with obtaining and processing samples in each of the subgroups of interest for these analyses.

II. To assess and explore differences in lymphocyte subsets (B-, T-, and NK) between those with vs. without cGVHD.

III. To assess and explore differences in cytokines in patients with cGVHD vs. those without.

IV. To describe lymphocyte subsets and activation and explore how these may be related to specific clinical manifestations of cGVHD.

OUTLINE:

Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunosorbent spot (ELISPOT), immunoblot, and microarray assays.

Study Type

Observational

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have received an autologous stem cell transplant and stem cell transplant at The Ohio State University.

Description

Inclusion Criteria:

  • Allogeneic SCT groups: Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic graft-versus-host disease (GVHD)
  • Autologous SCT group: Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment

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 SCT Groups
Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic GVHD.
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
Other Names:
  • laboratory biomarker analysis
  • Correlatives studies
Autologous SCT group
Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment.
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
Other Names:
  • laboratory biomarker analysis
  • Correlatives studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subsets and activation status of B, T, and NK lymphocytes
Time Frame: Up to 2 months
Side by side box plots with overlaid plotted points will be used to assess potential differences in continuous markers between groups.
Up to 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Logistical challenges with obtaining and processing samples in each of the subgroups of interest
Time Frame: Up to 2 months
Up to 2 months
Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
Time Frame: Up to 2 months
Up to 2 months
Differences in cytokines in patients with cGVHD vs. those without
Time Frame: Up to 2 months
Up to 2 months
Differences in in lymphocyte activation between those with vs. without cGVHD
Time Frame: Up to 2 months
Up to 2 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Samantha Jaglowski, MD, Ohio State University Comprehensive 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

February 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-12208
  • NCI-2013-01641 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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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