T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
NCT ID: NCT00651716
Last Updated: 2019-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
150 participants
OBSERVATIONAL
2006-12-31
2019-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Allogeneic Stem Cell Transplant Patients
Patients undergoing allogeneic stem cell transplant (SCT). Potential study candidates will be identified by participating physicians.
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.
laboratory biomarker analysis
Identification of gut-homing and skin-homing Treg subsets
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.
Interventions
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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.
laboratory biomarker analysis
Identification of gut-homing and skin-homing Treg subsets
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.
Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years
Exclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Brian Engelhardt, MD
Assistant Professor of Medicine; Hematologist/Oncologist
Principal Investigators
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Brian Engelhardt, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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VICC BMT 0653
Identifier Type: -
Identifier Source: org_study_id
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