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T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
This study is currently recruiting participants.
Study NCT00651716   Information provided by National Cancer Institute (NCI)
First Received: April 2, 2008   Last Updated: August 11, 2009   History of Changes

April 2, 2008
August 11, 2009
December 2006
December 2013   (final data collection date for primary outcome measure)
Percentage of regulatory T-lymphocytes (Tregs) at engraftment [ Designated as safety issue: No ]
Percentage of regulatory T lymphocytes (Tregs) at engraftment [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00651716 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
Regulatory T Cells at Engraftment as Predictors of Acute Graft-Versus-Host Disease Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation

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.

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.

 
Observational
 
  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Tumor
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Neuroblastoma
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • Other: flow cytometry
  • Other: laboratory biomarker analysis
  • Other: medical chart review
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
86
 
December 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Undergoing allogeneic stem cell transplantation

    • No more than 10 days from neutrophil engraftment
    • No death prior to neutrophil engraftment

PATIENT CHARACTERISTICS:

  • No other condition that, in the opinion of the investigator, would interfere with study objectives
  • No other reason that, in the opinion of the investigator, would add additional risk to the patient

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years and older
No
 
United States
 
NCT00651716
 
CDR0000583631, VU-VICC-BMT-0653, VU-VICC-061074
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Brian Engelhardt, MD Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP