Nctid:
NCT00001337
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002051", "term"=>"Burkitt Lymphoma"}, {"id"=>"D000008223", "term"=>"Lymphoma"}, {"id"=>"D000008228", "term"=>"Lymphoma, Non-Hodgkin"}, {"id"=>"D000016393", "term"=>"Lymphoma, B-Cell"}, {"id"=>"D000016403", "term"=>"Lymphoma, Large B-Cell, Diffuse"}, {"id"=>"D000017728", "term"=>"Lymphoma, Large-Cell, Anaplastic"}], "ancestors"=>[{"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D000008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D000007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000020031", "term"=>"Epstein-Barr Virus Infections"}, {"id"=>"D000006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D000004266", "term"=>"DNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014412", "term"=>"Tumor Virus Infections"}, {"id"=>"D000016399", "term"=>"Lymphoma, T-Cell"}], "browseLeaves"=>[{"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M18828", "name"=>"Lymphoma, B-Cell", "asFound"=>"B-cell Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M18831", "name"=>"Lymphoma, Large B-Cell, Diffuse", "asFound"=>"Diffuse Large B-Cell Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M3724", "name"=>"Aggression", "relevance"=>"LOW"}, {"id"=>"M19941", "name"=>"Lymphoma, Large-Cell, Anaplastic", "asFound"=>"Anaplastic Large Cell Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M5321", "name"=>"Burkitt Lymphoma", "asFound"=>"Burkitt lymphoma", "relevance"=>"HIGH"}, {"id"=>"M11222", "name"=>"Lymphoma, Non-Hodgkin", "asFound"=>"Non-Hodgkin Lymphoma", "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"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M21881", "name"=>"Epstein-Barr Virus Infections", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M17162", "name"=>"Tumor Virus Infections", "relevance"=>"LOW"}, {"id"=>"M18829", "name"=>"Lymphoma, T-Cell", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T640", "name"=>"B-cell Lymphoma", "asFound"=>"B-cell Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T1866", "name"=>"Diffuse Large B-Cell Lymphoma", "asFound"=>"Diffuse Large B-Cell Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T367", "name"=>"Anaplastic Large Cell Lymphoma", "asFound"=>"Anaplastic Large Cell Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T892", "name"=>"Burkitt Lymphoma", "asFound"=>"Burkitt lymphoma", "relevance"=>"HIGH"}, {"id"=>"T2619", "name"=>"Gray Zone Lymphoma", "asFound"=>"Gray Zone Lymphoma", "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"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000069283", "term"=>"Rituximab"}], "ancestors"=>[{"id"=>"D000074322", "term"=>"Antineoplastic Agents, Immunological"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018501", "term"=>"Antirheumatic Agents"}], "browseLeaves"=>[{"id"=>"M373", "name"=>"Rituximab", "asFound"=>"Healthy", "relevance"=>"HIGH"}, {"id"=>"M1346", "name"=>"Antineoplastic Agents, Immunological", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>348}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-05-08", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06-13", "completionDateStruct"=>{"date"=>"2024-05-24", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-06-15", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-18", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-24", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Overall response and PFS", "timeFrame"=>"Time of progression", "description"=>"The Dixon-Simon method will be used to determine whether large B-cell lymphomas expressing BCL-2 (+) patients may experience an improved progression free survival with EPOCH-R compared to EPOCH alone, and to obtain a concurrent, precisely determined measure of progression free survival."}], "secondaryOutcomes"=>[{"measure"=>"Safety and Toxicity", "timeFrame"=>"Initiation of study drug until 30 days after treatment", "description"=>"the proportion of patients with adverse events leading to discontinuation of therapy"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Primary Mediastinal B-Cell Lymphoma", "CD20 +", "Diffuse Large B-Cell Lymphoma", "Anaplastic Large Cell Lymphoma", "De Novo"], "conditions"=>["Diffuse Large B-Cell Lymphoma (DLBCL)", "Primary Mediastinal Large B-cell Lymphoma", "Burkitt Lymphoma", "Anaplastic Large-Cell Lymphoma", "Gray Zone Lymphoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"2580468", "type"=>"BACKGROUND", "citation"=>"Klimo P, Connors JM. MACOP-B chemotherapy for the treatment of diffuse large-cell lymphoma. Ann Intern Med. 1985 May;102(5):596-602. doi: 10.7326/0003-4819-102-5-596."}, {"pmid"=>"1682280", "type"=>"BACKGROUND", "citation"=>"Lai GM, Chen YN, Mickley LA, Fojo AT, Bates SE. P-glycoprotein expression and schedule dependence of adriamycin cytotoxicity in human colon carcinoma cell lines. Int J Cancer. 1991 Nov 11;49(5):696-703. doi: 10.1002/ijc.2910490512."}, {"pmid"=>"46388", "type"=>"BACKGROUND", "citation"=>"DeVita VT Jr, Canellos GP, Chabner B, Schein P, Hubbard SP, Young RC. Advanced diffuse histiocytic lymphoma, a potentially curable disease. Lancet. 1975 Feb 1;1(7901):248-50. doi: 10.1016/s0140-6736(75)91142-3."}, {"pmid"=>"34432874", "type"=>"DERIVED", "citation"=>"Miljkovic MD, Melani C, Pittaluga S, Lakhotia R, Lucas N, Jacob A, Yusko E, Jaffe ES, Wilson WH, Roschewski M. Next-generation sequencing-based monitoring of circulating tumor DNA reveals clonotypic heterogeneity in untreated PTCL. Blood Adv. 2021 Oct 26;5(20):4198-4210. doi: 10.1182/bloodadvances.2020003679."}, {"pmid"=>"30125215", "type"=>"DERIVED", "citation"=>"Kurtz DM, Scherer F, Jin MC, Soo J, Craig AFM, Esfahani MS, Chabon JJ, Stehr H, Liu CL, Tibshirani R, Maeda LS, Gupta NK, Khodadoust MS, Advani RH, Levy R, Newman AM, Duhrsen U, Huttmann A, Meignan M, Casasnovas RO, Westin JR, Roschewski M, Wilson WH, Gaidano G, Rossi D, Diehn M, Alizadeh AA. Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2018 Oct 1;36(28):2845-2853. doi: 10.1200/JCO.2018.78.5246. Epub 2018 Aug 20."}, {"pmid"=>"29748435", "type"=>"DERIVED", "citation"=>"Melani C, Advani R, Roschewski M, Walters KM, Chen CC, Baratto L, Ahlman MA, Miljkovic MD, Steinberg SM, Lam J, Shovlin M, Dunleavy K, Pittaluga S, Jaffe ES, Wilson WH. End-of-treatment and serial PET imaging in primary mediastinal B-cell lymphoma following dose-adjusted EPOCH-R: a paradigm shift in clinical decision making. Haematologica. 2018 Aug;103(8):1337-1344. doi: 10.3324/haematol.2018.192492. Epub 2018 May 10."}, {"pmid"=>"25024303", "type"=>"DERIVED", "citation"=>"Wilson WH, Pittaluga S, Nicolae A, Camphausen K, Shovlin M, Steinberg SM, Roschewski M, Staudt LM, Jaffe ES, Dunleavy K. A prospective study of mediastinal gray-zone lymphoma. Blood. 2014 Sep 4;124(10):1563-9. doi: 10.1182/blood-2014-03-564906. Epub 2014 Jul 14."}, {"pmid"=>"24224624", "type"=>"DERIVED", "citation"=>"Dunleavy K, Pittaluga S, Shovlin M, Steinberg SM, Cole D, Grant C, Widemann B, Staudt LM, Jaffe ES, Little RF, Wilson WH. Low-intensity therapy in adults with Burkitt's lymphoma. N Engl J Med. 2013 Nov 14;369(20):1915-25. doi: 10.1056/NEJMoa1308392."}, {"pmid"=>"23574119", "type"=>"DERIVED", "citation"=>"Dunleavy K, Pittaluga S, Maeda LS, Advani R, Chen CC, Hessler J, Steinberg SM, Grant C, Wright G, Varma G, Staudt LM, Jaffe ES, Wilson WH. Dose-adjusted EPOCH-rituximab therapy in primary mediastinal B-cell lymphoma. N Engl J Med. 2013 Apr 11;368(15):1408-16. doi: 10.1056/NEJMoa1214561."}], "seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1993-C-0133.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. EPOCH: Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), G-CSF, NSC-614629....", "detailedDescription"=>"Background:\n\nThe treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and children commonly induces complete responses in a sizable fraction of the treated population, and about 2/3 of the complete responders appear to have prolonged disease-free survival.\n\nThe present study assesses the activity and tolerability in previously untreated patients of a regimen of EPOCH infusional chemotherapy given intensively with G-CSF support.\n\nObjectives:\n\nPrimary:\n\nAssess complete response (CR) and progression-free survival (PFS) of dose-adjusted EPOCH-Rituximab (DA-EPOCH-R) with G-CSF in agressive B-cell lymphomas.\n\nEligibility:\n\nNon-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma (MGZL) and primary mediastinal B cell lymphoma (PMBL).\n\nPatients greater than or equal to 12 years old.\n\nAny Stage for PMBL and MGZL.\n\nNo prior systemic chemotherapy.\n\nHIV negative.\n\nDesign:\n\nThis study will estimate the complete response rate of a group of previously untreated patients and the extent to which EPOCH infusional drug delivery accompanied by a hematopoietic growth factor can increase the dose intensity of treatment.\n\nPatients receive prednisone orally for 5 days, a 96 hour infusion of vincristine, doxorubicin, and etoposide, and a bolus of cyclophosphamide on day 5.\n\nCycles are repeated every 21 days for a total of 6-8 cycles.\n\nPatients with CD20 expressing tumors (i.e. mature B-cell lymphomas) will also receive rituximab, the humanized monoclonal antibody against the CD20 receptor on day 1 of each cycle.\n\nA total of 348 patients will be enrolled on this protocol."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nNon-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma and primary mediastinal B cell\n\nlymphoma.\n\nDiagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, NCI. Tissue blocks from patients treated in extramural sites must be forwarded to the NCI for analysis of bcl-2 by IHC and other markers within 1 month of study entry.\n\nPatients greater than or equal to 12 years old.\n\nStage and Prognosis of Patients: Any stage for MGZL and PMBL.\n\nNo prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome).\n\nHIV negative.\n\nNot pregnant or nursing.\n\nAdequate major organ function \\[in adults: serum creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 ml/min; and in children serum CR less than or equal to age-adjusted normal (age 12 to 15 maximum serum creatinine 1.2 mg/dl and age greater than 15 maximum serum creatinine 1.5 mg/dl); bilirubin less than 1.5 mg/dl; ANC greater than 1,000 and platelets greater than 100,000) unless impairment is due to organ involvement by lymphoma or immune-mediated mechanism caused by lymphoma.\n\nNo active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If MUGA is obtained, the LVEF should exceed 40%.\n\nNo other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safety.\n\nNo history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cancer.\n\nAbility to give informed consent."}, "identificationModule"=>{"nctId"=>"NCT00001337", "briefTitle"=>"Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma", "nctIdAliases"=>["NCT00018980"], "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkin's Lymphoma", "orgStudyIdInfo"=>{"id"=>"930133"}, "secondaryIdInfos"=>[{"id"=>"93-C-0133"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Arm A", "description"=>"EPOCH + Rituximab every 3 weeks for 6 cycles.", "interventionNames"=>["Drug: EPOCH", "Biological: Rituximab"]}], "interventions"=>[{"name"=>"EPOCH", "type"=>"DRUG", "description"=>"Combination chemotherapy given with Rituximab (EPOCH-R) IV every 3 weeks for 6 cycles.", "armGroupLabels"=>["Arm A"]}, {"name"=>"Rituximab", "type"=>"BIOLOGICAL", "description"=>"Rituximab given on Day 1 of combination chemotherapy (EPOCH-R) every 3 weeks for 6 cycles.", "armGroupLabels"=>["Arm A"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33308", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"Holy Cross Hospital, Fort Lauderdale", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"21201-1595", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"University of Maryland, Baltimore", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}, {"zip"=>"02115", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Brigham and Women's Hospital", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"10025", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"St. Luke's Roosevelt Hospital", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}], "overallOfficials"=>[{"name"=>"Mark J Roschewski, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Cancer Institute (NCI)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
