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

Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01988701
• Other study ID #: OSU-12208
• Secondary ID: NCI-2013-01641
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2013
• Last updated: February 26, 2015
• Start date: February 2015

Study information

• Verified date: February 2015
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease
• Hematopoietic/Lymphoid Cancer

Intervention

Other:
• Ancillary-Correlative
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subsets and activation status of B, T, and NK lymphocytes	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	No
Secondary	Logistical challenges with obtaining and processing samples in each of the subgroups of interest		Up to 2 months	No
Secondary	Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD		Up to 2 months	No
Secondary	Differences in cytokines in patients with cGVHD vs. those without		Up to 2 months	No
Secondary	Differences in in lymphocyte activation between those with vs. without cGVHD		Up to 2 months	No

External Links

•   The Jamesline