Nctid:
NCT00002456
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008223", "term"=>"Lymphoma"}, {"id"=>"D007938", "term"=>"Leukemia"}, {"id"=>"D006086", "term"=>"Graft vs Host Disease"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}], "browseLeaves"=>[{"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M18127", "name"=>"Leukemia, Myeloid, Acute", "relevance"=>"LOW"}, {"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M10945", "name"=>"Leukemia", "asFound"=>"Leukemia", "relevance"=>"HIGH"}, {"id"=>"M27585", "name"=>"Precursor Cell Lymphoblastic Leukemia-Lymphoma", "relevance"=>"LOW"}, {"id"=>"M10951", "name"=>"Leukemia, Lymphoid", "relevance"=>"LOW"}, {"id"=>"M10955", "name"=>"Leukemia, Myeloid", "relevance"=>"LOW"}, {"id"=>"M18116", "name"=>"Leukemia, Lymphocytic, Chronic, B-Cell", "relevance"=>"LOW"}, {"id"=>"M18123", "name"=>"Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "relevance"=>"LOW"}, {"id"=>"M9189", "name"=>"Graft vs Host Disease", "asFound"=>"Graft Versus Host Disease", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative 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"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "relevance"=>"LOW"}, {"id"=>"T3995", "name"=>"Myeloid Leukemia", "relevance"=>"LOW"}, {"id"=>"T182", "name"=>"Acute Myeloid Leukemia", "relevance"=>"LOW"}, {"id"=>"T175", "name"=>"Acute Lymphoblastic Leukemia", "relevance"=>"LOW"}, {"id"=>"T3533", "name"=>"Lymphoblastic Lymphoma", "relevance"=>"LOW"}, {"id"=>"T188", "name"=>"Acute Non Lymphoblastic Leukemia", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1134", "name"=>"Childhood Acute Lymphoblastic Leukemia", "relevance"=>"LOW"}, {"id"=>"T1308", "name"=>"Chronic Lymphocytic Leukemia", "relevance"=>"LOW"}, {"id"=>"T1309", "name"=>"Chronic Myeloid Leukemia", "relevance"=>"LOW"}, {"id"=>"T2832", "name"=>"Homologous Wasting Disease", "asFound"=>"Graft Versus Host Disease", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D016572", "term"=>"Cyclosporine"}, {"id"=>"D008727", "term"=>"Methotrexate"}, {"id"=>"D003524", "term"=>"Cyclosporins"}], "ancestors"=>[{"id"=>"D000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000019", "term"=>"Abortifacient Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000935", "term"=>"Antifungal Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D065095", "term"=>"Calcineurin Inhibitors"}], "browseLeaves"=>[{"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Brain", "relevance"=>"HIGH"}, {"id"=>"M18961", "name"=>"Cyclosporine", "asFound"=>"/mL", "relevance"=>"HIGH"}, {"id"=>"M6730", "name"=>"Cyclosporins", "asFound"=>"/mL", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M30452", "name"=>"Calcineurin Inhibitors", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"SUPPORTIVE_CARE"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1986-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2011-11", "completionDateStruct"=>{"date"=>"2002-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2011-11-28", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-04-23", "lastUpdatePostDateStruct"=>{"date"=>"2011-11-30", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-04-26", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["recurrent childhood acute lymphoblastic leukemia", "childhood non-Hodgkin lymphoma", "recurrent childhood lymphoblastic lymphoma", "recurrent childhood acute myeloid leukemia", "recurrent adult acute myeloid leukemia", "recurrent adult acute lymphoblastic leukemia", "relapsing chronic myelogenous leukemia", "refractory chronic lymphocytic leukemia", "recurrent adult non-Hodgkin lymphoma", "graft versus host disease"], "conditions"=>["Graft Versus Host Disease", "Leukemia", "Lymphoma"]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against normal tissues. Methotrexate and cyclosporine may prevent this from happening.\n\nPURPOSE: Phase III trial to study the effectiveness of treatment with methotrexate and cyclosporine after bone marrow transplantation to provide protection against acute graft-versus-host disease.", "detailedDescription"=>"OBJECTIVES: I. Determine the efficacy of a combination of methotrexate and cyclosporine, administered after grafting, to prevent the development of acute graft versus host disease (GVHD) in patients undergoing allogeneic bone marrow transplantation.\n\nOUTLINE: Patients receive methotrexate IV on days 1,3,6, and 11. Patients also receive cyclosporine IV twice a day until the patient is eating, then it is administered orally twice a day. Cyclosporine begins on day -1 and continues until day 180. The dose is reduced beginning on day 50.\n\nPROJECTED ACCRUAL: Accrual will continue until further notice."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Ongoing bone marrow transplantation from HLA-matched siblings or HLA non-identical family members or unrelated donor\n\nPATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not severely limited by disease other than leukemia Hematopoietic: Not specified Hepatic: No severe hepatic disease Renal: No history of hemorrhagic cystitis No renal disease Cardiovascular No symptomatic cardiac disease Other: No contraindication to the use of cyclosporine or methotrexate\n\nPRIOR CONCURRENT THERAPY: No concurrent experimental treatment on other GVHD prophylaxis studies"}, "identificationModule"=>{"nctId"=>"NCT00002456", "briefTitle"=>"Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation", "organization"=>{"class"=>"OTHER", "fullName"=>"Fred Hutchinson Cancer Center"}, "officialTitle"=>"Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease", "orgStudyIdInfo"=>{"id"=>"267.01"}, "secondaryIdInfos"=>[{"id"=>"FHCRC-267.01"}, {"id"=>"FHCRC-267.00"}, {"id"=>"NCI-V86-0145"}, {"id"=>"CDR0000074146", "type"=>"REGISTRY", "domain"=>"PDQ"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"cyclosporine", "type"=>"DRUG"}, {"name"=>"methotrexate", "type"=>"DRUG"}, {"name"=>"allogeneic bone marrow transplantation", "type"=>"PROCEDURE"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"98109", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Fred Hutchinson Cancer Research Center", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"Rainer F. Storb, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Fred Hutchinson Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fred Hutchinson Cancer Center", "class"=>"OTHER"}}}}
