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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00813501 |
RATIONALE: Studying a diagnostic biomarker test in blood samples from patients who have undergone a donor stem cell transplant for cancer may help doctors plan treatment.
PURPOSE: This clinical trial is studying an immunologic diagnostic blood test to see how well it works in predicting side-effects in patients with hematologic cancer or other disorders who have undergone a donor stem cell transplant.
Condition | Intervention |
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Chronic Myeloproliferative Disorders Graft Versus Host Disease Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Therapy-Related Toxicity |
Biological: immunosuppressive therapy Other: immunological diagnostic method Procedure: allogeneic hematopoietic stem cell transplantation |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Evaluation of Clinical Utility of the Cylex ImmunKnow Assay in Hematopoietic Cell Transplantation |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Beginning on day 14 after allogeneic hematopoietic stem cell transplantation (HSCT), patients undergo blood sample collection at least once weekly for the first 100 days and then once to twice monthly for up to 1 year, in the absence of graft-versus-host disease (GVHD). If chronic or acute GVHD develops after day 100, more frequent blood sampling may occur. Blood sample collection is coordinated with the time of regular clinic visits to allow for evaluation of the clinical events recorded 2 weeks before and after the blood draw date. Blood samples are analyzed by the Cylex® and ImmuKnow® assays to measure global T-cell immune function and responsiveness to alterations in immunosuppressive post-HSCT therapy. Assay data obtained during the first 3 weeks and other post-transplant periods will be evaluated for possible correlations with clinical endpoints (i.e., GVHD incidence, rate of infection, and response to immunosuppressive therapy) to assess the predictive value of the assay.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org |
Principal Investigator: | David Senitzer, PhD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( David Senitzer ) |
Study ID Numbers: | CDR0000628793, CHNMC-07200 |
Study First Received: | December 20, 2008 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00813501 History of Changes |
Health Authority: | Unspecified |
graft versus host disease infection therapy-related toxicity 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 |
Chronic Myelomonocytic Leukemia Blast Crisis Neuroectodermal Tumors, Primitive Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Graft Versus Host Disease Mycoses Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Neuroepithelioma |
Hodgkin Disease Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Hairy Cell Leukemia Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Neuroectodermal Tumors B-cell Lymphomas |
Neuroectodermal Tumors, Primitive Immunologic Factors Precancerous Conditions Blood Protein Disorders Physiological Effects of Drugs Neoplasms, Nerve Tissue Paraproteinemias Infection Hemostatic Disorders Neuroblastoma Leukemia Preleukemia Pathologic Processes Hemorrhagic Disorders Neoplasms, Germ Cell and Embryonal |
Syndrome Lymphoma, Large-Cell, Immunoblastic Cardiovascular Diseases Lymphoma Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma |