[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100331048":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":233,"collaborators":236,"id":276,"slug":12,"hasResults":277,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":12,"eligibilityCriteria":281,"healthyVolunteers":277,"sex":282,"minAge":12,"maxAge":283,"enrollmentInfo":284,"targetDuration":12,"studyType":287,"phases":288,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":303},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm HR-A","NO_INTERVENTION","Induction: Backbone ALL R3",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Arm HR-B","EXPERIMENTAL","Induction: Backbone ALL R3 + Bortezomib",[18],"Drug: Bortezomib",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Bortezomib","Patients randomised to the HR-B arm receive induction, consolidation with the modified ALL R3 protocol. In this arm, patients are randomized to receive Bortezomib together with the ALL R3 protocol during induction. Administration of Bortezomib: 1.3 mg\u002Fm2 as intravenous bolus or subcutaneously (SC, at the discretion of the treating physician) on days 1 and 4 of weeks 1 and 3.",[14],[26],{"name":27,"affiliation":5,"role":28},"Arend von Stackelberg, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","+49(0)30-450666","833","arend.stackelberg@charite.de",[36,52,67,80,92,106,119,131,144,157,169,182,195,207,220],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Australian & New Zealand Childhood Hematology & Oncology Group","RECRUITING","Clayton","Victoria","3168","Australia",{"type":44,"coordinates":45},"Point",[46,47],145.11667,-37.91667,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":12,"phoneExt":12,"email":12},"Tamas Revesz, MD",{"facility":53,"status":38,"city":54,"state":12,"zip":55,"country":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"St. Anna Kinderkrebsforschung, CCRI","Vienna","1090","Austria",{"type":44,"coordinates":58},[59,60],16.37208,48.20849,{"lat":60,"lon":59},[63,65],{"name":64,"role":31,"phone":12,"phoneExt":12,"email":12},"Georg Mann, MD",{"name":66,"role":31,"phone":12,"phoneExt":12,"email":12},"Andishe Atterbashi, MD",{"facility":68,"status":38,"city":69,"state":12,"zip":70,"country":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hòpital Universitaire des Enfants Reine Fabiola","Brussels","1020","Belgium",{"type":44,"coordinates":73},[74,75],4.34878,50.85045,{"lat":75,"lon":74},[78],{"name":79,"role":31,"phone":12,"phoneExt":12,"email":12},"Alina Ferster, MD",{"facility":81,"status":38,"city":82,"state":12,"zip":12,"country":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"University Hospital Motol","Prague","Czechia",{"type":44,"coordinates":85},[86,87],14.42076,50.08804,{"lat":87,"lon":86},[90],{"name":91,"role":31,"phone":12,"phoneExt":12,"email":12},"Lucie Sramkova, MD",{"facility":93,"status":94,"city":95,"state":12,"zip":96,"country":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Copenhagen University Hospital (Rigshospitalet)","NOT_YET_RECRUITING","Copenhagen","2100","Denmark",{"type":44,"coordinates":99},[100,101],12.56553,55.67594,{"lat":101,"lon":100},[104],{"name":105,"role":31,"phone":12,"phoneExt":12,"email":12},"Thomas Frandsen, MD",{"facility":107,"status":38,"city":108,"state":12,"zip":109,"country":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Turku University Central Hospital","Turku","SF-20520","Finland",{"type":44,"coordinates":112},[113,114],22.26869,60.45148,{"lat":114,"lon":113},[117],{"name":118,"role":31,"phone":12,"phoneExt":12,"email":12},"Päivi Lähteenmäki, MD",{"facility":120,"status":38,"city":121,"state":12,"zip":12,"country":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"CHU Nice","Nice","France",{"type":44,"coordinates":124},[125,126],7.26608,43.70313,{"lat":126,"lon":125},[129],{"name":130,"role":31,"phone":12,"phoneExt":12,"email":12},"Pierre Rohrlich, MD",{"facility":132,"status":38,"city":133,"state":12,"zip":134,"country":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Tel Aviv Sourasky Medical Centre","Tel Aviv","64239","Israel",{"type":44,"coordinates":137},[138,139],34.78057,32.08088,{"lat":139,"lon":138},[142],{"name":143,"role":31,"phone":12,"phoneExt":12,"email":12},"Ronit Elhasid, MD",{"facility":145,"status":38,"city":146,"state":12,"zip":147,"country":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Ospedale Pediatrico Bambino Gesù","Roma","00165","Italy",{"type":44,"coordinates":150},[151,152],11.10642,44.99364,{"lat":152,"lon":151},[155],{"name":156,"role":31,"phone":12,"phoneExt":12,"email":12},"Franco Locatelli, MD",{"facility":158,"status":38,"city":159,"state":12,"zip":12,"country":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Prinses Máxima Centrum, Lundlaan","Utrecht","Netherlands",{"type":44,"coordinates":162},[163,164],5.12222,52.09083,{"lat":164,"lon":163},[167],{"name":168,"role":31,"phone":12,"phoneExt":12,"email":12},"Peter Hoogerbrugge, MD",{"facility":170,"status":94,"city":171,"state":12,"zip":172,"country":173,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Oslo University Hospital","Oslo","0027","Norway",{"type":44,"coordinates":175},[176,177],10.74609,59.91273,{"lat":177,"lon":176},[180],{"name":181,"role":31,"phone":12,"phoneExt":12,"email":12},"Marit Hellebostad, MD",{"facility":183,"status":38,"city":184,"state":12,"zip":185,"country":186,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Dpt. SCT and Hematology\u002FOncology University Wroclaw","Wroclaw","50354","Poland",{"type":44,"coordinates":188},[189,190],17.03006,51.10286,{"lat":190,"lon":189},[193],{"name":194,"role":31,"phone":12,"phoneExt":12,"email":12},"Ewa Goczynska, MD",{"facility":196,"status":94,"city":197,"state":12,"zip":12,"country":198,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Instituto Português de Oncologia de Lisboa","Lisbon","Portugal",{"type":44,"coordinates":200},[201,202],-9.1498,38.72509,{"lat":202,"lon":201},[205],{"name":206,"role":31,"phone":12,"phoneExt":12,"email":12},"Joaquin Duarte, MD",{"facility":208,"status":94,"city":209,"state":12,"zip":210,"country":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"University Hospital Stockholm","Stockholm","17176","Sweden",{"type":44,"coordinates":213},[214,215],18.06871,59.32938,{"lat":215,"lon":214},[218],{"name":219,"role":31,"phone":12,"phoneExt":12,"email":12},"Petter Svenberg, MD",{"facility":221,"status":94,"city":222,"state":12,"zip":223,"country":224,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Royal Manchester Children's Hospital","Manchester","M13 9WL","United Kingdom",{"type":44,"coordinates":226},[227,228],-2.23743,53.48095,{"lat":228,"lon":227},[231],{"name":232,"role":31,"phone":12,"phoneExt":12,"email":12},"Denise Bonney, MD",{"type":28,"investigatorFullName":234,"investigatorTitle":235,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PD Dr. Arend von Stackelberg","Prinicipal Investigator",[237,239,242,245,247,249,251,253,255,257,259,261,263,265,267,269,271,273],{"name":238,"class":6},"Australian & New Zealand Children's Haematology\u002FOncology Group",{"name":240,"class":241},"St. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria)","UNKNOWN",{"name":243,"class":244},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",{"name":246,"class":6},"University Hospital, Motol",{"name":248,"class":6},"Rigshospitalet, Denmark",{"name":250,"class":241},"Turku University Central Hospital (co-sponsor, Finland)",{"name":252,"class":6},"Centre Hospitalier Universitaire de Nice",{"name":254,"class":241},"Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)",{"name":256,"class":241},"Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)",{"name":258,"class":241},"Ospedale Pediatrico Bambino (co-sponsor, Italy)",{"name":260,"class":241},"Prinses Máxima Centrum (Co-Sponsor Netherlands)",{"name":262,"class":241},"Oslo University Hospital (co-sponsor, Norway)",{"name":264,"class":6},"Wroclaw Medical University",{"name":266,"class":241},"Instituto Português de Oncologia de Lisboa (co-sponsor, Portugal)",{"name":268,"class":241},"Karolinska University Hospital Stockholm (co-sponsor, Sweden)",{"name":270,"class":241},"Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)",{"name":272,"class":6},"University Children's Hospital, Zurich",{"name":274,"class":275},"Manchester University NHS Foundation Trust","OTHER_GOV","100331048",false,"NCT03590171","International Study for Treatment of High Risk Childhood Relapsed ALL 2010","International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group","Inclusion Criteria:\n\n* Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL\n* Children less than 18 years of age at date of inclusion into the study\n* Meeting HR criteria any BM relapse, early\u002Fvery early isolated BM relapse, very early isolated\u002Fcombined extramedullary relapse)\n* Patient enrolled in a participating centre\n* Written informed consent\n* Start of treatment falling into the study period\n* No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL\n\nExclusion Criteria:\n\n* Breakpoint cluster region-Abelson (BCR-ABL)\u002F t(9;22) positive ALL\n* Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) \\> 10 U\u002Fl)\n* Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \\\u003C1) until 12 months after end of anti-leukemic therapy\n* Breast feeding\n* Relapse post allogeneic stem-cell transplantation\n* Neuropathy \\> II°\n* The whole protocol or essential parts are declined either by patient himself\u002Fherself or the respective legal guardian\n* Objection to the study participation by a minor patient, able to object\n* Any patient being dependent on the investigator\n* No consent is given for saving and propagation of pseudonymized medical data for study reasons\n* Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)\n* Subjects unwilling or unable to comply with the study procedures\n* Subjects who are legally detained in an official institute","ALL","17 Years",{"count":285,"type":286},250,"ESTIMATED","INTERVENTIONAL",[289],"PHASE2","The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.",[292],"Acute Lymphoblastic Leukemia (ALL)",[282],"2026-03-16",{"date":296,"type":297},"2026-03-17","ACTUAL",{"date":299,"type":297},"2017-09-01",{"date":301,"type":286},"2027-12-31",{"name":5,"class":6},15]