Clinical Trial: T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational
Official Title: Regulatory T Cells at Engraftment as Predictors of Acute Graft-Versus-Host Disease Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Brief Summary:
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict whether patients undergoing donor stem cell transplant will develop acute graft-versus-host disease.
PURPOSE: This clinical trial is studying T cells to see how well they help in predicting acute graft-versus-host disease in patients undergoing donor stem cell transplant.
Detailed Summary:
OBJECTIVES:
- To determine the association between regulatory T-lymphocyte (Treg) subsets present at engraftment and at day 28 with the incidence of acute graft-versus-host-disease (aGVHD) in patients undergoing allogeneic stem cell transplantation.
- To identify gut-homing and skin-homing Treg subsets and determine their role during engraftment and at day 28 as a predictor of gut and skin aGVHD, respectively.
OUTLINE: Patients undergo blood sample collection at the time of neutrophil engraftment prior to stem cell transplant (SCT) and post-SCT on days 7, 14, 21, and 28 days after allogeneic stem cell transplantation. Blood samples are analyzed for T-cell subsets and for the percentage of regulatory T-lymphocyte (Treg) or other T-cell subsets expressing specific homing receptors for the gut or skin via flow cytometry.
Patients' medical records are also reviewed periodically.
Sponsor: Vanderbilt-Ingram Cancer Center
Current Primary Outcome: Percentage of regulatory T-lymphocytes (Tregs) at engraftment [ Time Frame: day of stem cell transplant ]
Original Primary Outcome: Percentage of regulatory T-lymphocytes (Tregs) at engraftment
Current Secondary Outcome: Association between Treg subsets and acute graft-vs.-host disease outcomes [ Time Frame: at stem cell transplant and at day 28 ]
Original Secondary Outcome:
- Association between Treg subsets and acute graft-vs-host disease outcomes, including incidence, severity, target organ involvement, and responsiveness to therapy
- Comparison of possible risk factors (e.g., percentage of Tregs) with survival
Information By: Vanderbilt-Ingram Cancer Center
Dates:
Date Received: April 2, 2008
Date Started: December 2006
Date Completion: December 2018
Last Updated: June 22, 2016
Last Verified: June 2016