T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Allogeneic Stem Cell Transplant Patients Patients undergoing allogeneic stem cell transplant (SCT). Potential study candidates will be identified by participating physicians. |
Other: flow cytometry
Lymphocyte Analysis: Lymphocyte subset studies will be performed on samples obtained from the patient, donor, or graft. Aliquots will be analyzed using standard flow cytometry.
Other: laboratory biomarker analysis
Identification of gut-homing and skin-homing Treg subsets
Other: Data Collection
Patient samples will receive an alphanumeric code assigned by the principal investigator so that patient and donor identity will be known only to study investigators and research staff. Clinical records on each patient will be reviewed by participating investigators or research staff on a routine basis so that relevant clinical information including survival, malignancy relapse, and GVHD can be included in the patient database. Flow cytometry results will also be included in this database.
|
Outcome Measures
Primary Outcome Measures
- Percentage of regulatory T-lymphocytes (Tregs) at engraftment [day of stem cell transplant]
percentage of Treg subsets present in patient's blood before they undergo stem cell transplant
Secondary Outcome Measures
- Association between Treg subsets and acute graft-vs.-host disease outcomes [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.
Eligibility Criteria
Criteria
Inclusion criteria:
-
Patients undergoing allogeneic SCT
-
Age >= 18 years
Exclusion criteria:
-
Inability to give informed consent
-
Patients who have not received an allogeneic SCT
-
Any condition which, in the opinion of the investigator, might interfere with study objective
-
Any reason which, in the opinion of the investigator, adds additional risk to the patient
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232-6838 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- VICC BMT 0653
- P30CA068485