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

Withdrawn

• Conditions: Graft Versus Host Disease; Hematopoietic/Lymphoid Cancer
• Interventions: Other: Ancillary-Correlative

• Registration Number: NCT01988701
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-20
• Status Verified: 2015-02
• Study Start: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-03-02
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allogeneic SCT Groups	Ancillary-Correlative	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.
Autologous SCT group	Ancillary-Correlative	Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment.

Primary Outcome Measures

Name	Time	Method
Subsets and activation status of B, T, and NK lymphocytes	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.

Secondary Outcome Measures

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