[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100391566":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":57,"responsibleParty":209,"collaborators":51,"id":211,"slug":51,"hasResults":212,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":212,"sex":218,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":51,"studyType":224,"phases":225,"briefSummary":227,"conditions":228,"keywords":51,"overallStatus":60,"whyStopped":51,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"fullName":5,"class":6},"Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Induction ESHAP","ACTIVE_COMPARATOR","3 Cycles ESHAP ( 21 days) : Etoposide \\[40 mg\u002Fm2\u002F day IV, D1-4\\], Solumedrol \\[250 mg\u002Fday IV, D1-4\\], High dose Ara-C \\[2 g\u002Fm2 IV, D5\\] Cisplatinum \\[25 mg\u002Fm2\u002Fday IV, D1-4\\]",[13,14],"Drug: Induction without Brentuximab Vedotin","Drug: Consolidation with Brentuximab Vedotin",{"label":16,"type":17,"description":18,"interventionNames":19},"Induction BV-ESHAP","EXPERIMENTAL","3 Cycles of Brentuximab VEedotin + ESHAP ( 21 days) : Etoposide \\[40 mg\u002Fm2\u002F day IV, D1-4\\], Solumedrol \\[250 mg\u002Fday IV, D1-4\\], High dose Ara-C \\[2 g\u002Fm2 IV, D5\\] Cisplatinum \\[25 mg\u002Fm2\u002Fday IV, D1-4\\] Brentuximab Vedotin \\[1.8 mg\u002Fkg IV, D1\\]",[20,14],"Drug: Induction with Brentuximab vedotin (BV)",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Induction with Brentuximab vedotin (BV)","3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg\u002Fkg IV",[16],[28],"Adcetris treatment + ESHAP as salvage therapy",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Induction without Brentuximab Vedotin","3 cycles of ESHAP as a standard of care therapy for those patients with primary refractory cHL and those patients relapsing after first-line therapy",[9],[34],"ESHAP treatment as salvage therapy",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Consolidation with Brentuximab Vedotin","Up to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg\u002Fkg iv every 21 days)",[16,9],[40],"Adcetris treatment as consolidation",[42],{"name":43,"affiliation":44,"role":45},"Anna Sureda, PhD","Institut Català d'Oncologia, Hospital Duran i Reynals","PRINCIPAL_INVESTIGATOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"lucia palacios, MSc","CONTACT","+18599134526",null,"ensayosclinicos01@geltamo.com",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":56},"Angel Cedillo, MSc","+34 91315780","sc@geltamo.com",[58,71,81,91,100,106,112,118,123,132,141,150,156,162,168,177,186,195,204],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":51},"Institut Català D'Oncologia - Hospital Germans Trias I Pujol","RECRUITING","Barcelona","Barceolna","08916","Spain",{"type":66,"coordinates":67},"Point",[68,69],2.15899,41.38879,{"lat":69,"lon":68},{"facility":72,"status":60,"city":73,"state":74,"zip":75,"country":64,"cosmosGeoPoint":76,"geoPoint":80,"contacts":51},"Hospital Universitario Marqués de Valdecilla","Santander","Cantabria","39008",{"type":66,"coordinates":77},[78,79],-3.80493,43.46589,{"lat":79,"lon":78},{"facility":82,"status":60,"city":83,"state":84,"zip":85,"country":64,"cosmosGeoPoint":86,"geoPoint":90,"contacts":51},"Hospital Universitario Central de Asturias","Oviedo","Principality of Asturias","33011",{"type":66,"coordinates":87},[88,89],-5.84476,43.36029,{"lat":89,"lon":88},{"facility":92,"status":60,"city":93,"state":51,"zip":94,"country":64,"cosmosGeoPoint":95,"geoPoint":99,"contacts":51},"Complexo Hospitalario Universitario A Coruña","A Coruña","15006",{"type":66,"coordinates":96},[97,98],-8.396,43.37135,{"lat":98,"lon":97},{"facility":101,"status":60,"city":61,"state":51,"zip":102,"country":64,"cosmosGeoPoint":103,"geoPoint":105,"contacts":51},"Hospital Clínic de Barcelona","08036",{"type":66,"coordinates":104},[68,69],{"lat":69,"lon":68},{"facility":107,"status":60,"city":61,"state":51,"zip":108,"country":64,"cosmosGeoPoint":109,"geoPoint":111,"contacts":51},"Hospital de La Santa Creu I Sant Pau","08041",{"type":66,"coordinates":110},[68,69],{"lat":69,"lon":68},{"facility":113,"status":60,"city":61,"state":51,"zip":114,"country":64,"cosmosGeoPoint":115,"geoPoint":117,"contacts":51},"Institut Català D'Oncologia - Hospital Duran I Reynals","08908",{"type":66,"coordinates":116},[68,69],{"lat":69,"lon":68},{"facility":119,"status":60,"city":61,"state":51,"zip":114,"country":64,"cosmosGeoPoint":120,"geoPoint":122,"contacts":51},"Institut Català D'Oncologia",{"type":66,"coordinates":121},[68,69],{"lat":69,"lon":68},{"facility":124,"status":60,"city":125,"state":51,"zip":126,"country":64,"cosmosGeoPoint":127,"geoPoint":131,"contacts":51},"Hospital Universitario de Cruces","Bilbao","48903",{"type":66,"coordinates":128},[129,130],-2.92528,43.26271,{"lat":130,"lon":129},{"facility":133,"status":60,"city":134,"state":51,"zip":135,"country":64,"cosmosGeoPoint":136,"geoPoint":140,"contacts":51},"Hospital Universitario Virgen de Las Nieves","Granada","18014",{"type":66,"coordinates":137},[138,139],-3.60667,37.18817,{"lat":139,"lon":138},{"facility":142,"status":60,"city":143,"state":51,"zip":144,"country":64,"cosmosGeoPoint":145,"geoPoint":149,"contacts":51},"Hospital General Universitario Gregorio Marañón","Madrid","28007",{"type":66,"coordinates":146},[147,148],-3.70256,40.4165,{"lat":148,"lon":147},{"facility":151,"status":60,"city":143,"state":51,"zip":152,"country":64,"cosmosGeoPoint":153,"geoPoint":155,"contacts":51},"Hospital Ramón Y Cajal","28034",{"type":66,"coordinates":154},[147,148],{"lat":148,"lon":147},{"facility":157,"status":60,"city":143,"state":51,"zip":158,"country":64,"cosmosGeoPoint":159,"geoPoint":161,"contacts":51},"Hospital Universitario Fundación Jiménez Díaz","28040",{"type":66,"coordinates":160},[147,148],{"lat":148,"lon":147},{"facility":163,"status":60,"city":143,"state":51,"zip":164,"country":64,"cosmosGeoPoint":165,"geoPoint":167,"contacts":51},"Hospital Universitario 12 de Octubre","28041",{"type":66,"coordinates":166},[147,148],{"lat":148,"lon":147},{"facility":169,"status":60,"city":170,"state":51,"zip":171,"country":64,"cosmosGeoPoint":172,"geoPoint":176,"contacts":51},"Hospital General Universitario J.M. Morales Meseguer","Murcia","30008",{"type":66,"coordinates":173},[174,175],-1.13004,37.98704,{"lat":175,"lon":174},{"facility":178,"status":60,"city":179,"state":51,"zip":180,"country":64,"cosmosGeoPoint":181,"geoPoint":185,"contacts":51},"Hospital Universitario de Salamanca","Salamanca","37007",{"type":66,"coordinates":182},[183,184],-5.66388,40.96882,{"lat":184,"lon":183},{"facility":187,"status":60,"city":188,"state":51,"zip":189,"country":64,"cosmosGeoPoint":190,"geoPoint":194,"contacts":51},"Hospital Universitario Virgen Del Rocío","Seville","41013",{"type":66,"coordinates":191},[192,193],-5.97317,37.38283,{"lat":193,"lon":192},{"facility":196,"status":60,"city":197,"state":51,"zip":198,"country":64,"cosmosGeoPoint":199,"geoPoint":203,"contacts":51},"Hospital Universitario Y Politécnico La Fe","Valencia","46026",{"type":66,"coordinates":200},[201,202],-0.37966,39.47391,{"lat":202,"lon":201},{"facility":205,"status":60,"city":197,"state":51,"zip":51,"country":64,"cosmosGeoPoint":206,"geoPoint":208,"contacts":51},"Hospital Clínico Universitario de Valencia",{"type":66,"coordinates":207},[201,202],{"lat":202,"lon":201},{"type":210,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100391566",false,"NCT04378647","BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant","A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy With Brentuximab Vedotin-ESHAP vs ESHAP in Patients With Relapsed \u002F Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (Instead of Autologous Hematopoietic Stem Cell Transplantation) in Those Who Attained a Metabolic Complete Remission After Salvage Therapy","BRESELIBET","Inclusion Criteria:\n\nPatients with classical HL CD30+ confirmed histologically (either at the time of diagnosis \u002F at the time of first relapse) will be included in the trial\n\n* Male or female patients 18 to 65 years of age\n* Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care\n* Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse\n* Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse\n* ECOG 0 to 2\n* Measurable disease at time of enrolment (lymphadenopathy\u002F extranodal mass of at least 1.5 cm)\n* No evidence of neuropathy grade ≥2\n* Clinical laboratory values as specified in the protocol below within 7 days before the first dose of study drug\n\nExclusion Criteria:\n\n* Lymphocyte predominant nodular Hodgkin's lymphoma\n* Prior treatment with brentuximab vedotin\n* Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.\n* Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)\n* Symptomatic neurologic disease compromising normal activities of daily living or requiring medic\n* Any sensory or motor peripheral neuropathy greater than or equal to Grade 2\n* Known history of any of the following cardiovascular conditions defined in the protocol\n* Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose\n* Patients that have not completed any prior treatment chemotherapy and\u002For other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment\n* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.\n* Known human immunodeficiency virus (HIV) positive\n* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection\n* Focal radiation therapy within 30 days prior to study recruitment\n* Major surgery within 28 days prior to randomization\n* Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease.\n* Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.","ALL","18 Years","65 Years",{"count":222,"type":223},150,"ESTIMATED","INTERVENTIONAL",[226],"PHASE2","A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed \u002F Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy",[229],"Hodgkin Lymphoma, Adult","2024-02-23",{"date":232,"type":233},"2024-02-26","ACTUAL",{"date":235,"type":233},"2020-06-01",{"date":237,"type":223},"2026-08-30",{"name":5,"class":6},19]