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 ]

percentage of Treg subsets present in patient's blood before they undergo 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 ]

Identify gut homing and skin homing Treg lymphocyte subsets and compare and contrast them to determine links between the Treg subsets and gut and/or skin acute graft-vs.-host-disease incidence, stage/grade, target organ involvement, and responsiveness to therapy.


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