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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01988701
Enrollment
0
Registered
2013-11-20
Start date
2015-02-28
Completion date
Unknown
Last updated
2015-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease, Hematopoietic/Lymphoid Cancer

Keywords

GVHD, chronic Graft versus Host Disease

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.

Interventions

OTHERAncillary-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.

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Subsets and activation status of B, T, and NK lymphocytesUp to 2 monthsSide by side box plots with overlaid plotted points will be used to assess potential differences in continuous markers between groups.

Secondary

MeasureTime frame
Logistical challenges with obtaining and processing samples in each of the subgroups of interestUp to 2 months
Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHDUp to 2 months
Differences in cytokines in patients with cGVHD vs. those withoutUp to 2 months
Differences in in lymphocyte activation between those with vs. without cGVHDUp to 2 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026