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.
Primary Outcome Measures:
- Percentage of regulatory T-lymphocytes (Tregs) at engraftment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Association between Treg subsets and acute graft-vs-host disease outcomes, including incidence, severity, target organ involvement, and responsiveness to therapy [ Designated as safety issue: No ]
- Comparison of possible risk factors (e.g., percentage of Tregs) with survival [ Designated as safety issue: No ]
| Estimated Enrollment: |
86 |
| Study Start Date: |
December 2006 |
| Estimated Primary Completion Date: |
December 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To determine the association between regulatory T-lymphocyte (Treg) subsets present at engraftment and at day 30 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 30 as a predictor of gut and skin aGVHD, respectively.
OUTLINE: Patients undergo blood sample collection at the time of neutrophil engraftment and at 30 and 90 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.