[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100112002":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":133,"collaborators":20,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":138,"sex":144,"minAge":145,"maxAge":20,"enrollmentInfo":146,"targetDuration":20,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":164,"whyStopped":20,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"1. Consolidation with Y90 Ibritumomab Tiuxetan","EXPERIMENTAL","1\\. Consolidation with Y90 Ibritumomab Tiuxetan",[13],"Drug: Y90 Ibritumomab Tiuxetan",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Y90 Ibritumomab Tiuxetan","Consolidation with Y90 Ibritumomab Tiuxetan",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Mariano Provencio, MD","Clínica Puerta de Hierro","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+34-91-344-57-60","mprovenciop@yahoo.es",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Sandra Cerdeira, Secretary","34 91 3445131","secretariatecnica@grupolinfomas.es",[36,48,59,64,73,81,90,99,108,117,125],{"facility":37,"status":38,"city":39,"state":39,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":20},"Hospital Virgen de las Nieves","ACTIVE_NOT_RECRUITING","Granada","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],-3.60667,37.18817,{"lat":46,"lon":45},{"facility":49,"status":50,"city":51,"state":51,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Clinia Puerta de Hierro","RECRUITING","Madrid",{"type":43,"coordinates":53},[54,55],-3.70256,40.4165,{"lat":55,"lon":54},[58],{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":60,"status":38,"city":51,"state":51,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":61,"geoPoint":63,"contacts":20},"Clínica Ruber Internacional",{"type":43,"coordinates":62},[54,55],{"lat":55,"lon":54},{"facility":65,"status":38,"city":66,"state":67,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":68,"geoPoint":72,"contacts":20},"Hospital Virgen de la 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Tenerife",{"type":43,"coordinates":95},[96,97],-16.32014,28.4853,{"lat":97,"lon":96},{"facility":100,"status":38,"city":101,"state":102,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":103,"geoPoint":107,"contacts":20},"Hospital Universitario Virgen Macarena","Seville","Sevilla",{"type":43,"coordinates":104},[105,106],-5.97317,37.38283,{"lat":106,"lon":105},{"facility":109,"status":38,"city":110,"state":111,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":112,"geoPoint":116,"contacts":20},"Hospital Sant Joan de Reus","Reus","Tarragona",{"type":43,"coordinates":113},[114,115],1.10687,41.15612,{"lat":115,"lon":114},{"facility":118,"status":38,"city":119,"state":119,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":120,"geoPoint":124,"contacts":20},"Hospital Virgen de la Salud de Toledo","Toledo",{"type":43,"coordinates":121},[122,123],-4.02263,39.8581,{"lat":123,"lon":122},{"facility":126,"status":38,"city":127,"state":127,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":128,"geoPoint":132,"contacts":20},"Hospital Universitario La Fe","Valencia",{"type":43,"coordinates":129},[130,131],-0.37966,39.47391,{"lat":131,"lon":130},{"type":20,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":134,"oldOrganization":135},"Dr. Mariano Provencio","Clínica Puerta de Hierro, Servicio de Oncología Médica","100112002","phase-2-consolidation-treatment-with-y90-ibritumomab-tiuxetan-after-r-chop-induction-in-high-risk-patients-according-to-follicular-lymphoma-international-prognostic-index-flipi-with-follicular-lymphoma-100112002",false,"NCT00722930","Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma","Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy","GOTEL-FL1LC","Inclusion Criteria:\n\n* Signature of the written informed consent by the subject or his\u002Fher legal representative before initiation of any trial specific procedure.\n* Patients older than 18.\n* Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO classification.\n* High-risk patients according to FLIPI before initiation of induction chemotherapy.\n* Stage II-IV prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma.\n* Complete or partial response to the induction scheme.\n* ECOG scale performance status 0 - 2.\n* Life expectancy greater than 3 months.\n* In women of childbearing age, use of a reliable contraceptive method.\n* A suitable bone marrow reserve:\n\n  * Lower than 25% Bone marrow infiltration by lymphoma.\n  * Hb 10 g\u002FdL. PMN leukocytes 1,500 cel\u002Fmm3, platelets 100,000\u002Fmm3\n  * Suitable hepatic, renal and cardiac function:\n\n    * creatinine \\\u003C2,5 x UNL (upper normality limit).\n    * bilirubin or ALT\u002FAST \\\u003C 2,5 x UNL\n\nExclusion Criteria:\n\n* Patients with no objective clinical response to induction chemotherapy.\n* \\> 25% bone marrow infiltration following induction chemotherapy.\n* Platelets \\\u003C 100,000 before radioimmunotherapy.\n* Severe and\u002For uncontrolled concomitant disease:\n* Hepatic, renal, cardiovascular, neurological or metabolic disease.\n* Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia.\n* Positive regarding HBV, HCV, HIV.\n* Active acute or chronic infection.\n* Social, psychic or geographic disability to satisfy any of the treatment schemes.\n* Pregnant and\u002For breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter.\n* Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).","ALL","18 Years",{"count":147,"type":148},38,"ESTIMATED","INTERVENTIONAL",[151],"PHASE2","To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy",[154],"Follicular Lymphoma",[154,156,157,158,159,160,161,162,163],"High-risk FLIPI","R-CHOP","GOTEL","Partial","Complete","Response","Induction","Chemotherapy","UNKNOWN","2008-07-25",{"date":167,"type":148},"2008-07-28",{"date":169,"type":20},"2008-04",{"date":171,"type":148},"2013-04",{"name":5,"class":6},11]