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:	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	Other: flow cytometry Other: laboratory biomarker analysis Other: medical chart review

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia breast cancer hemophilia

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

U.S. FDA Resources

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, 37064
Contact: Brian Engelhardt 615-936-1803
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000583631, VU-VICC-BMT-0653, VU-VICC-061074
Study First Received:	April 2, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00651716 History of Changes
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

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Urogenital Neoplasms
Preleukemia
Pathologic Processes
Neoplasms by Site
Hemorrhagic Disorders
Cardiovascular Diseases
Breast Diseases
Endocrine Gland Neoplasms
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myeloproliferative Disorders
Genital Neoplasms, Female
Breast Neoplasms

Endocrine System Diseases
Multiple Myeloma
Neuroectodermal Tumors
Neoplasms
Gestational Trophoblastic Neoplasms
Lymphoma, Non-Hodgkin
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Pregnancy Complications
Precancerous Conditions
Gonadal Disorders
Blood Protein Disorders
Neoplasms, Nerve Tissue
Paraproteinemias
Ovarian Diseases

ClinicalTrials.gov processed this record on November 27, 2009