Clinical trial NCT01988701: Lymphocyte Profiles and Activation Status in Patients With Graft-Versus-Host Disease
Official title: Lymphocyte Profiles and Activation Status in the Development of Chronic Graft-versus-Host Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Graft Versus Host Disease
Hematopoietic/Lymphoid Cancer
Keywords: GVHD
chronic Graft versus Host Disease
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: Subsets and activation status of B, T, and NK lymphocytes
timeFrame: Up to 2 months
Secondary outcomes:
measure: Logistical challenges with obtaining and processing samples in each of the subgroups of interest
timeFrame: Up to 2 months
measure: Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
timeFrame: Up to 2 months
measure: Differences in cytokines in patients with cGVHD vs. those without
timeFrame: Up to 2 months
measure: Differences in in lymphocyte activation between those with vs. without cGVHD
timeFrame: Up to 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Samantha Jaglowski, MD
role: PRINCIPAL_INVESTIGATOR
References: