[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100391566":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":57,"responsibleParty":210,"collaborators":51,"id":212,"slug":213,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":214,"sex":220,"minAge":221,"maxAge":222,"enrollmentInfo":223,"targetDuration":51,"studyType":226,"phases":227,"briefSummary":229,"conditions":230,"keywords":51,"overallStatus":60,"whyStopped":51,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},{"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",[58,72,82,92,101,107,113,119,124,133,142,151,157,163,169,178,187,196,205],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":51},"Institut Català D'Oncologia - 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Fe","Valencia","46026",{"type":67,"coordinates":201},[202,203],-0.37966,39.47391,{"lat":203,"lon":202},{"facility":206,"status":60,"city":198,"state":51,"zip":51,"country":64,"countryCode":65,"cosmosGeoPoint":207,"geoPoint":209,"contacts":51},"Hospital Clínico Universitario de Valencia",{"type":67,"coordinates":208},[202,203],{"lat":203,"lon":202},{"type":211,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100391566","phase-2-brentuximab-vedotin-in-second-line-therapy-before-transplant-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":224,"type":225},150,"ESTIMATED","INTERVENTIONAL",[228],"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",[231],"Hodgkin Lymphoma, Adult","2024-02-23",{"date":234,"type":235},"2024-02-26","ACTUAL",{"date":237,"type":235},"2020-06-01",{"date":239,"type":225},"2026-08-30",{"name":5,"class":6},19]