Nctid:
NCT00001533
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015458", "term"=>"Leukemia, T-Cell"}, {"id"=>"D000013921", "term"=>"Thrombocytopenia"}, {"id"=>"D000009503", "term"=>"Neutropenia"}, {"id"=>"D000008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D000008218", "term"=>"Lymphocytosis"}], "ancestors"=>[{"id"=>"D000007938", "term"=>"Leukemia"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000001791", "term"=>"Blood Platelet Disorders"}, {"id"=>"D000095542", "term"=>"Cytopenia"}, {"id"=>"D000000380", "term"=>"Agranulocytosis"}, {"id"=>"D000007970", "term"=>"Leukopenia"}, {"id"=>"D000007960", "term"=>"Leukocyte Disorders"}, {"id"=>"D000008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D000007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000007964", "term"=>"Leukocytosis"}, {"id"=>"D000007945", "term"=>"Leukemia, Lymphoid"}], "browseLeaves"=>[{"id"=>"M10945", "name"=>"Leukemia", "relevance"=>"LOW"}, {"id"=>"M4070", "name"=>"Anemia", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "asFound"=>"Lymphoproliferative Disorders", "relevance"=>"HIGH"}, {"id"=>"M16680", "name"=>"Thrombocytopenia", "asFound"=>"Thrombocytopenia", "relevance"=>"HIGH"}, {"id"=>"M12443", "name"=>"Neutropenia", "asFound"=>"Neutropenia", "relevance"=>"HIGH"}, {"id"=>"M18119", "name"=>"Leukemia, T-Cell", "asFound"=>"Leukemia, T-Cell", "relevance"=>"HIGH"}, {"id"=>"M11215", "name"=>"Lymphocytosis", "asFound"=>"Lymphocytosis", "relevance"=>"HIGH"}, {"id"=>"M27552", "name"=>"Leukemia, Large Granular Lymphocytic", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M5072", "name"=>"Blood Platelet Disorders", "relevance"=>"LOW"}, {"id"=>"M3170", "name"=>"Cytopenia", "relevance"=>"LOW"}, {"id"=>"M3730", "name"=>"Agranulocytosis", "relevance"=>"LOW"}, {"id"=>"M10973", "name"=>"Leukopenia", "relevance"=>"LOW"}, {"id"=>"M10963", "name"=>"Leukocyte Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M10967", "name"=>"Leukocytosis", "relevance"=>"LOW"}, {"id"=>"M10951", "name"=>"Leukemia, Lymphoid", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T2606", "name"=>"Granulocytopenia", "asFound"=>"Neutropenia", "relevance"=>"HIGH"}, {"id"=>"T238", "name"=>"Aggressive NK Cell Leukemia", "relevance"=>"LOW"}, {"id"=>"T5568", "name"=>"T-cell Large Granular Lymphocyte Leukemia", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000016572", "term"=>"Cyclosporine"}, {"id"=>"D000003524", "term"=>"Cyclosporins"}], "ancestors"=>[{"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000935", "term"=>"Antifungal Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000003879", "term"=>"Dermatologic Agents"}, {"id"=>"D000018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000065095", "term"=>"Calcineurin Inhibitors"}], "browseLeaves"=>[{"id"=>"M18961", "name"=>"Cyclosporine", "asFound"=>"Either", "relevance"=>"HIGH"}, {"id"=>"M6730", "name"=>"Cyclosporins", "asFound"=>"Either", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M30452", "name"=>"Calcineurin Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>25}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-10", "completionDateStruct"=>{"date"=>"2000-09"}, "lastUpdateSubmitDate"=>"2006-07-14", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2006-07-17", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Anemia", "Chronic T Cell Lymphocytosis with Neutropenia", "Immunosuppression", "Neutropenia", "T-LGL Leukemia"], "conditions"=>["Anemia", "Leukemia, T-Cell", "Lymphocytosis", "Neutropenia", "Thrombocytopenia"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8324214", "type"=>"BACKGROUND", "citation"=>"Loughran TP Jr. Clonal diseases of large granular lymphocytes. Blood. 1993 Jul 1;82(1):1-14."}, {"pmid"=>"7920220", "type"=>"BACKGROUND", "citation"=>"Witzig TE, Weitz JJ, Lundberg JH, Tefferi A. Treatment of refractory T-cell chronic lymphocytic leukemia with purine nucleoside analogues. Leuk Lymphoma. 1994 Jun;14(1-2):137-9. doi: 10.3109/10428199409049659."}, {"pmid"=>"8562948", "type"=>"BACKGROUND", "citation"=>"Gabor EP, Mishalani S, Lee S. Rapid response to cyclosporine therapy and sustained remission in large granular lymphocyte leukemia. Blood. 1996 Feb 1;87(3):1199-200. No abstract available."}]}, "descriptionModule"=>{"briefSummary"=>"T Cell Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders are a heterogeneous group of uncommon diseases which may involve a polyclonal or a monoclonal T cell population, which bear characteristic surface markers corresponding to activated cytotoxic (CD3+, CD8+) lymphocytes. They are often associated with quite severe neutropenia, anemia, and thrombocytopenia which may be life-threatening. There is some evidence that the abnormal cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis, although the mechanism is unclear. Case reports suggest that immunosuppressive therapy directed toward T cells may reverse the cytopenia. This pilot study involving up to 25 patients evaluates the clinical response to cyclosporine, an immunosuppressive drug, and seeks to elucidate the mechanism underlying the cytopenia.", "detailedDescription"=>"T Cell Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders are a heterogeneous group of uncommon diseases which may involve a polyclonal or a monoclonal T cell population, which bear characteristic surface markers corresponding to activated cytotoxic (CD3+, CD8+) lymphocytes. They are often associated with quite severe neutropenia, anemia, and thrombocytopenia which may be life-threatening. There is some evidence that the abnormal cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis, although the mechanism is unclear. Case reports suggest that immunosuppressive therapy directed toward T cells may reverse the cytopenia. This pilot study involving up to 25 patients evaluates the clinical response to cyclosporine, an immunosuppressive drug, and seeks to elucidate the mechanism underlying the cytopenia."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Patients must be greater than or equal to 18 years of age.\n\nPeripheral blood absolute LGL count of greater than or equal to 300/ul (performed on a manual differential), with LGL cells having the characteristic appearance of large lymphocytes with abundant pale blue cytoplasm, with or without a perinuclear clear zone, with varying degrees of azurophilic granules.\n\nImmunophenotypic studies of peripheral blood showing an increased population of T-LGL (Staining for: CD3, CD8, and either CD16 or CD57+/- CD56).\n\nSevere neutropenia (less than or equal to 500 neutrophils/uL of peripheral blood), or severe thrombocytopenia (less than or equal to 20,000 platelets/uL, or moderate thrombocytopenia (less than or equal to 50,000 platelets/uL with active bleeding , or anemia (hemoglobin less than or equal to 9 gm/dL), or red blood cell transfusion requirement of greater than or equal to 2 units/month for two months prior to initiation of CsA treatment.\n\nPatients must not have had previous treatment with CsA or FK506.\n\nPatients must not have a reactive LGL lymphocytosis to a viral infection.\n\nPatients must not have a ECOG performance status of greater than 3.\n\nPatients must not be currently pregnant, or unwilling to take oral contraceptives unless postmenopausal.\n\nMothers must not be breast feeding.\n\nPatients must be able to give informed consent.\n\nPatients must not be HIV positive."}, "identificationModule"=>{"nctId"=>"NCT00001533", "briefTitle"=>"Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine", "orgStudyIdInfo"=>{"id"=>"960142"}, "secondaryIdInfos"=>[{"id"=>"96-H-0142"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"cyclosporine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Heart, Lung and Blood Institute (NHLBI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}}}}
