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

The Ohio State University

Status: Withdrawn

Conditions: Graft Versus Host Disease; Hematopoietic/Lymphoid Cancer

Treatments: Other: Ancillary-Correlative

Study type: Observational

Funder types: Other

Identifiers

NCT01988701

OSU-12208

NCI-2013-01641 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

0 participants in 2 patient groups

Allogeneic SCT Groups

Description:

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.

Treatment:

Other: Ancillary-Correlative

Autologous SCT group

Description:

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

Treatment:

Other: Ancillary-Correlative