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

N/AWithdrawnNCT01988701

Ohio State University Comprehensive Cancer Center

Overview

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.

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

Conditions

Graft Versus Host Disease Hematopoietic/Lymphoid Cancer

Interventions

Ancillary-CorrelativeOTHER

Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 2 months

Secondary Outcomes

Logistical challenges with obtaining and processing samples in each of the subgroups of interest

Time frame: Up to 2 months

Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD

Time frame: Up to 2 months

Differences in cytokines in patients with cGVHD vs. those without

Time frame: Up to 2 months

Differences in in lymphocyte activation between those with vs. without cGVHD

Time frame: Up to 2 months

Data from ClinicalTrials.gov

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