Nctid:
NCT00002838
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007938", "term"=>"Leukemia"}, {"id"=>"D007945", "term"=>"Leukemia, Lymphoid"}, {"id"=>"D015451", "term"=>"Leukemia, Lymphocytic, Chronic, B-Cell"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D015448", "term"=>"Leukemia, B-Cell"}, {"id"=>"D002908", "term"=>"Chronic Disease"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M10945", "name"=>"Leukemia", "asFound"=>"Leukemia", "relevance"=>"HIGH"}, {"id"=>"M10951", "name"=>"Leukemia, Lymphoid", "asFound"=>"Lymphocytic Leukemia", "relevance"=>"HIGH"}, {"id"=>"M18116", "name"=>"Leukemia, Lymphocytic, Chronic, B-Cell", "asFound"=>"Chronic Lymphocytic Leukemia", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "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"=>"M18115", "name"=>"Leukemia, B-Cell", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1308", "name"=>"Chronic Lymphocytic Leukemia", "asFound"=>"Chronic Lymphocytic Leukemia", "relevance"=>"HIGH"}], "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"=>"D003520", "term"=>"Cyclophosphamide"}, {"id"=>"C024352", "term"=>"Fludarabine"}, {"id"=>"C042382", "term"=>"Fludarabine phosphate"}], "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"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000963", "term"=>"Antimetabolites"}], "browseLeaves"=>[{"id"=>"M1945", "name"=>"Lenograstim", "relevance"=>"LOW"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Tablet", "relevance"=>"HIGH"}, {"id"=>"M283230", "name"=>"Fludarabine", "asFound"=>"Monitoring", "relevance"=>"HIGH"}, {"id"=>"M225513", "name"=>"Fludarabine phosphate", "asFound"=>"Syringe", "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"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1", "PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>13}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-07", "completionDateStruct"=>{"date"=>"2002-07", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2012-07-27", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-06-15", "lastUpdatePostDateStruct"=>{"date"=>"2012-07-31", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-06-16", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2002-07", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Feasibility + Toxicity of Combination Chemotherapy Plus Peripheral Stem Cell Transplantation", "timeFrame"=>"Monthly"}]}, "oversightModule"=>{"oversightHasDmc"=>false}, "conditionsModule"=>{"keywords"=>["stage III chronic lymphocytic leukemia", "stage IV chronic lymphocytic leukemia", "refractory chronic lymphocytic leukemia"], "conditions"=>["Leukemia"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"http://www.mdanderson.org", "label"=>"UT MD Anderson Cancer Center website"}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells.\n\nPURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.", "detailedDescription"=>"OBJECTIVES: I. Determine the feasibility and toxicity of using allogeneic peripheral blood stem cell transplantation after intensive, but non-myeloablative chemotherapy with fludarabine/cyclophosphamide in patients with advanced chronic lymphocytic leukemia. II. Determine the engraftment kinetics and degree of chimerism available with this strategy.\n\nOUTLINE: This is a nonrandomized, dose-seeking study. Stem cell donors receive G-CSF for 4 days prior to and throughout stem cell harvest. Patients receive intensive chemotherapy with fludarabine and cyclophosphamide for 3 days, with patients entered at increasing doses of both drugs until the dose allowing engraftment is determined. Three days after intensive chemotherapy, allogeneic stem cells are infused. Responding patients who do not experience worse than grade 1 acute graft-vs.-host disease receive additional stem cell infusions after 60 and 120 days. Patients are followed monthly for 4 months, at 6 and 12 months, then yearly for 5 years.\n\nPROJECTED ACCRUAL: Up to 25 patients will be entered."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Advanced chronic lymphocytic leukemia (Rai stage 3 or 4) with at least one of the following high-risk factors: Beta-2 microglobulin 3 or greater Abnormalities of chromosome 17 Other cytogenetic abnormalities Refractory to fludarabine-based chemotherapy or failure to achieve complete remission after 6 courses of a fludarabine-based regimen HLA-identical sibling donor willing and able to undergo apheresis for harvest of G-CSF-stimulated peripheral blood stem cells\n\nPATIENT CHARACTERISTICS: Age: 65 and under Performance status: Zubrod 0 or 1 Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No symptomatic cardiac disease Pulmonary: No symptomatic pulmonary disease Other: No active uncontrolled infection\n\nPRIOR CONCURRENT THERAPY: See Disease Characteristics"}, "identificationModule"=>{"nctId"=>"NCT00002838", "briefTitle"=>"Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia", "organization"=>{"class"=>"OTHER", "fullName"=>"M.D. Anderson Cancer Center"}, "officialTitle"=>"Phase I/II Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia", "orgStudyIdInfo"=>{"id"=>"DM95-194"}, "secondaryIdInfos"=>[{"id"=>"P30CA016672", "link"=>"https://reporter.nih.gov/quickSearch/P30CA016672", "type"=>"NIH"}, {"id"=>"MDA-DM-95194", "type"=>"OTHER", "domain"=>"UT MD Anderson Cancer Center"}, {"id"=>"NCI-V96-1018"}, {"id"=>"CDR0000065053", "type"=>"REGISTRY", "domain"=>"NCI PDQ"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Combination Chemotherapy + PSCT", "description"=>"PSCT = Peripheral Stem Cell Transplantation", "interventionNames"=>["Biological: Filgrastim (G-CSF)", "Drug: Cyclophosphamide", "Drug: Fludarabine Phosphate", "Procedure: Peripheral Blood Stem Cell Transplantation"]}], "interventions"=>[{"name"=>"Filgrastim (G-CSF)", "type"=>"BIOLOGICAL", "otherNames"=>["G-CSF", "Neupogen"], "armGroupLabels"=>["Combination Chemotherapy + PSCT"]}, {"name"=>"Cyclophosphamide", "type"=>"DRUG", "otherNames"=>["Cytoxan", "Neosar"], "armGroupLabels"=>["Combination Chemotherapy + PSCT"]}, {"name"=>"Fludarabine Phosphate", "type"=>"DRUG", "otherNames"=>["Fludara"], "armGroupLabels"=>["Combination Chemotherapy + PSCT"]}, {"name"=>"Peripheral Blood Stem Cell Transplantation", "type"=>"PROCEDURE", "otherNames"=>["PBSCT", "Stem Cell Transplant"], "armGroupLabels"=>["Combination Chemotherapy + PSCT"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"University of Texas - MD Anderson Cancer Center", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}], "overallOfficials"=>[{"name"=>"Issa Khouri, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"M.D. Anderson Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"M.D. Anderson Cancer Center", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}