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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.
Verified by National Cancer Institute (NCI), April 2008

Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00651716
  Purpose

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 Intervention
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
Procedure: flow cytometry
Procedure: laboratory biomarker analysis
Procedure: medical chart review

Genetics Home Reference related topics:   aceruloplasminemia    breast cancer    hemophilia   

MedlinePlus related topics:   Breast Cancer    Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma    Multiple Myeloma    Neuroblastoma    Ovarian Cancer   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

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)

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651716

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs     Recruiting
      Nashville, Tennessee, United States
      Contact: Brian Engelhardt     6-0975        
Vanderbilt-Ingram Cancer Center at Franklin     Recruiting
      Nashville, Tennessee, United States
      Contact: Brian Engelhardt     6-0975        
Vanderbilt-Ingram Cancer Center     Recruiting
      Nashville, Tennessee, United States, 37232-6838
      Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center     800-811-8480        

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Brian Engelhardt, MD     Vanderbilt-Ingram Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000583631, VU-VICC-BMT-0653, VU-VICC-061074
First Received:   April 2, 2008
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00651716
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III adult Burkitt lymphoma  
stage III adult diffuse large cell lymphoma  
stage III adult diffuse mixed cell lymphoma  
stage III adult diffuse small cleaved cell lymphoma  
stage III adult Hodgkin lymphoma  
stage III adult immunoblastic large cell lymphoma  
stage III adult lymphoblastic lymphoma  
stage III grade 1 follicular lymphoma  
stage III grade 2 follicular lymphoma  
stage III grade 3 follicular lymphoma  
stage III mantle cell lymphoma  
stage III marginal zone lymphoma  
stage III small lymphocytic lymphoma  
stage IV adult Burkitt lymphoma  
stage IV adult diffuse large cell lymphoma  
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Lymphoma, large-cell, immunoblastic
Preleukemia
Hemorrhagic Disorders
Neoplasm Metastasis
Neuroepithelioma
Endocrine Gland Neoplasms
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Genital Neoplasms, Female
Acute myelogenous leukemia
Breast Neoplasms
Testicular Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Lymphoma, Non-Hodgkin
Hairy cell leukemia
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Lymphoma, Follicular

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Pregnancy Complications, Neoplastic
Immune System Diseases
Blood Protein Disorders
Neoplasms, Nerve Tissue
Adnexal Diseases
Neoplasms
Neoplasms by Site
Pathologic Processes
Syndrome
Cardiovascular Diseases
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on August 21, 2008




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