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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00651716 |
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 |
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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 |
Estimated Enrollment: | 86 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Undergoing allogeneic stem cell transplantation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Brian Engelhardt, MD | Vanderbilt-Ingram Cancer Center |
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 |
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 |
Blast Crisis Urogenital Neoplasms Mantle Cell Lymphoma Graft Versus Host Disease Preleukemia Hemorrhagic Disorders Neoplasm Metastasis Neuroepithelioma Ovarian Cancer Myelodysplastic Myeloproliferative Disease Endocrine Gland Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Testicular Cancer Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Genital Neoplasms, Female Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial Precancerous Conditions Blood Protein Disorders Lymphoma, Follicular Sezary Syndrome Lymphoblastic Lymphoma |
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 |