Nctid:
NCT00002792
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009196", "term"=>"Myeloproliferative Disorders"}, {"id"=>"D054437", "term"=>"Myelodysplastic-Myeloproliferative Diseases"}], "ancestors"=>[{"id"=>"D006402", "term"=>"Hematologic Diseases"}, {"id"=>"D001855", "term"=>"Bone Marrow Diseases"}], "browseLeaves"=>[{"id"=>"M10945", "name"=>"Leukemia", "relevance"=>"LOW"}, {"id"=>"M10955", "name"=>"Leukemia, Myeloid", "relevance"=>"LOW"}, {"id"=>"M18123", "name"=>"Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "relevance"=>"LOW"}, {"id"=>"M13972", "name"=>"Polycythemia Vera", "relevance"=>"LOW"}, {"id"=>"M28312", "name"=>"Primary Myelofibrosis", "relevance"=>"LOW"}, {"id"=>"M12149", "name"=>"Myeloproliferative Disorders", "asFound"=>"Myeloproliferative Disorders", "relevance"=>"HIGH"}, {"id"=>"M13971", "name"=>"Polycythemia", "relevance"=>"LOW"}, {"id"=>"M16681", "name"=>"Thrombocytosis", "relevance"=>"LOW"}, {"id"=>"M16679", "name"=>"Thrombocythemia, Essential", "relevance"=>"LOW"}, {"id"=>"M11659", "name"=>"Metaplasia", "relevance"=>"LOW"}, {"id"=>"M27707", "name"=>"Myelodysplastic-Myeloproliferative Diseases", "asFound"=>"Myelodysplastic/myeloproliferative disease", "relevance"=>"HIGH"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M5134", "name"=>"Bone Marrow Diseases", "relevance"=>"LOW"}, {"id"=>"T3995", "name"=>"Myeloid Leukemia", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1309", "name"=>"Chronic Myeloid Leukemia", "relevance"=>"LOW"}, {"id"=>"T4705", "name"=>"Primary Myelofibrosis", "relevance"=>"LOW"}, {"id"=>"T1311", "name"=>"Chronic Myeloproliferative Disorders", "asFound"=>"Chronic Myeloproliferative Disorders", "relevance"=>"HIGH"}, {"id"=>"T4614", "name"=>"Polycythemia Vera", "relevance"=>"LOW"}, {"id"=>"T2144", "name"=>"Essential Thrombocythemia", "relevance"=>"LOW"}, {"id"=>"T3994", "name"=>"Myelodysplastic/myeloproliferative Disease", "asFound"=>"Myelodysplastic/myeloproliferative disease", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D016572", "term"=>"Cyclosporine"}, {"id"=>"D003520", "term"=>"Cyclophosphamide"}, {"id"=>"D002066", "term"=>"Busulfan"}, {"id"=>"D008727", "term"=>"Methotrexate"}, {"id"=>"D016559", "term"=>"Tacrolimus"}, {"id"=>"D003524", "term"=>"Cyclosporins"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000019", "term"=>"Abortifacient Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D065095", "term"=>"Calcineurin Inhibitors"}, {"id"=>"D000935", "term"=>"Antifungal Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Tablet", "relevance"=>"HIGH"}, {"id"=>"M18961", "name"=>"Cyclosporine", "asFound"=>"6 weeks", "relevance"=>"HIGH"}, {"id"=>"M6730", "name"=>"Cyclosporins", "asFound"=>"6 weeks", "relevance"=>"HIGH"}, {"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Medication", "relevance"=>"HIGH"}, {"id"=>"M18950", "name"=>"Tacrolimus", "asFound"=>"Term", "relevance"=>"HIGH"}, {"id"=>"M5336", "name"=>"Busulfan", "asFound"=>"Call", "relevance"=>"HIGH"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"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"=>"M30452", "name"=>"Calcineurin Inhibitors", "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"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic 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"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2010-03", "completionDateStruct"=>{"date"=>"2003-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2010-03-31", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2010-04-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-01-27", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2003-04", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["polycythemia vera", "chronic idiopathic myelofibrosis", "essential thrombocythemia", "atypical chronic myeloid leukemia", "myelodysplastic/myeloproliferative disease, unclassifiable"], "conditions"=>["Chronic Myeloproliferative Disorders", "Leukemia", "Myelodysplastic/Myeloproliferative Diseases"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9326205", "type"=>"RESULT", "citation"=>"Anderson JE, Sale G, Appelbaum FR, Chauncey TR, Storb R. Allogeneic marrow transplantation for primary myelofibrosis and myelofibrosis secondary to polycythaemia vera or essential thrombocytosis. Br J Haematol. 1997 Sep;98(4):1010-6. doi: 10.1046/j.1365-2141.1997.3083125.x."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.", "detailedDescription"=>"OBJECTIVES:\n\n* Assess disease free survival in patients with idiopathic myelofibrosis treated with a preparative busulfan/cyclophosphamide regimen followed by allogeneic bone marrow or peripheral blood stem cell transplantation.\n* Determine the risk of primary graft failure in these patients.\n\nOUTLINE: Patients receive a preparative regimen consisting of oral busulfan every 6 hours on days -7 through -4 and cyclophosphamide on days -3 and -2. Patients then receive allogeneic bone marrow or peripheral blood stem cells on day 0. Patients registered on protocol FHCRC-1106.00 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem cells from an HLA-identical donor.\n\nPatients receive cyclosporine/methotrexate or tacrolimus/methotrexate as prophylaxis for graft-versus-host disease (GVHD). Patients receiving marrow from unrelated donors are eligible for appropriate GVHD prophylaxis studies.\n\nPatients are followed at 6 and 12 months after transplant.\n\nPROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study over approximately 3.5 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Idiopathic myelofibrosis (IMF) with at least 1 poor prognosis characteristic, including but not limited to:\n\n * Hemoglobin less than 10 g/dL\n * Platelet count less than 100,000/mm\\^3\n * Hepatomegaly (i.e., palpable liver edge 5 cm below costal margin)\n * Clinical requirement for splenectomy\n* Other myeloproliferative disorders in an IMF like myelofibrotic state eligible\n* No evidence of leukemic progression, e.g.:\n\n * Greater than 15% peripheral blood blasts\n * Fever or bone pain of unknown origin\n * Rapidly progressing splenomegaly\n* No other causes for myelofibrosis, such as:\n\n * Collagen vascular disorder\n * Lymphoma\n * Granulomatous infection\n * Metastatic carcinoma\n * Hairy cell leukemia\n * Myelodysplastic syndrome\n* No active central nervous system disease\n* One of the following donor/patient pairings is required:\n\n * Donor status:\n\n * Genotypic or phenotypic HLA-matched relative\n\n * Maximum patient age of 65\n * One antigen HLA-mismatched relative, HLA-matched unrelated donor, or one antigen HLA-mismatched unrelated donor\n\n * Maximum patient age of 55\n* Transplant on this protocol allowed for patients registered on protocol FHCRC-1106.00\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 65 and under\n\nPerformance status:\n\n* Not specified\n\nHematopoietic:\n\n* See Disease Characteristics\n\nHepatic:\n\n* Bilirubin no greater than 2 times normal\n* SGPT no greater than 4 times normal\n\nRenal:\n\n* Creatinine no greater than two times normal OR\n* Creatinine clearance at least 50%\n\nCardiovascular:\n\n* Ejection fraction at least 50%\n* Cardiac evaluation required if signs or symptoms of coronary artery disease or congestive heart failure\n\nOther:\n\n* HIV negative\n* No active infection\n* Patients excluded from this protocol are referred to protocol FHCRC-179.05\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified"}, "identificationModule"=>{"nctId"=>"NCT00002792", "briefTitle"=>"Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders", "organization"=>{"class"=>"OTHER", "fullName"=>"Fred Hutchinson Cancer Center"}, "officialTitle"=>"ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS", "orgStudyIdInfo"=>{"id"=>"1032.01"}, "secondaryIdInfos"=>[{"id"=>"FHCRC-1032.01"}, {"id"=>"NCI-H96-0929"}, {"id"=>"CDR0000064859", "type"=>"REGISTRY", "domain"=>"PDQ"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"busulfan", "type"=>"DRUG"}, {"name"=>"cyclophosphamide", "type"=>"DRUG"}, {"name"=>"cyclosporine", "type"=>"DRUG"}, {"name"=>"methotrexate", "type"=>"DRUG"}, {"name"=>"tacrolimus", "type"=>"DRUG"}, {"name"=>"allogeneic bone marrow transplantation", "type"=>"PROCEDURE"}, {"name"=>"peripheral blood stem cell 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"=>"H. Joachim Deeg, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Fred Hutchinson Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fred Hutchinson Cancer Center", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}]}}}