T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant - Full Text View

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Vanderbilt-Ingram Cancer Center
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 Neoplasms Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor	Other: flow cytometry Other: laboratory biomarker analysis Other: medical chart review

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Regulatory T Cells at Engraftment as Predictors of Acute Graft-Versus-Host Disease Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:

Percentage of regulatory T-lymphocytes (Tregs) at engraftment [ Time Frame: 100 days after transplant ] [ 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 [ Time Frame: 100 days after transplant ] [ Designated as safety issue: No ]
Comparison of possible risk factors (e.g., percentage of Tregs) with survival [ Time Frame: 100 days after transplant ] [ Designated as safety issue: No ]

Enrollment:	92
Study Start Date:	December 2006
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Blood samples	Other: flow cytometry Blood collections Other: laboratory biomarker analysis Blood collections Other: medical chart review Blood collections

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
Sampling Method:	Probability Sample

Study Population

People with a disease which is being treated with a bone marrow and/or a stem cell transplant.

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
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Brian Engelhardt, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Brian Engelhardt, M.D., Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00651716 History of Changes
Other Study ID Numbers:	VICC-BMT-0653, P30CA068485, VU-VICC-BMT-0653, VU-VICC-061074
Study First Received:	April 2, 2008
Last Updated:	April 19, 2011
Health Authority:	United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:

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

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Graft vs Host Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Neuroblastoma
Ovarian Neoplasms
Trophoblastic Neoplasms

Lymphoma, Large-Cell, Immunoblastic
Neoplasms, Germ Cell and Embryonal
Gestational Trophoblastic Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Immune System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012