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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",[36,53,69,83,95,110,124,137,151,165,178,192,206,219,233],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Australian & New Zealand Childhood Hematology & Oncology Group","RECRUITING","Clayton","Victoria","3168","Australia","AU",{"type":45,"coordinates":46},"Point",[47,48],145.11667,-37.91667,{"lat":48,"lon":47},[51],{"name":52,"role":31,"phone":12,"phoneExt":12,"email":12},"Tamas Revesz, MD",{"facility":54,"status":38,"city":55,"state":12,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"St. Anna Kinderkrebsforschung, CCRI","Vienna","1090","Austria","AT",{"type":45,"coordinates":60},[61,62],16.37208,48.20849,{"lat":62,"lon":61},[65,67],{"name":66,"role":31,"phone":12,"phoneExt":12,"email":12},"Georg Mann, MD",{"name":68,"role":31,"phone":12,"phoneExt":12,"email":12},"Andishe Atterbashi, MD",{"facility":70,"status":38,"city":71,"state":12,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Hòpital Universitaire des Enfants Reine Fabiola","Brussels","1020","Belgium","BE",{"type":45,"coordinates":76},[77,78],4.34878,50.85045,{"lat":78,"lon":77},[81],{"name":82,"role":31,"phone":12,"phoneExt":12,"email":12},"Alina Ferster, MD",{"facility":84,"status":38,"city":85,"state":12,"zip":12,"country":86,"countryCode":12,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University Hospital Motol","Prague","Czechia",{"type":45,"coordinates":88},[89,90],14.42076,50.08804,{"lat":90,"lon":89},[93],{"name":94,"role":31,"phone":12,"phoneExt":12,"email":12},"Lucie Sramkova, MD",{"facility":96,"status":97,"city":98,"state":12,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Copenhagen University Hospital (Rigshospitalet)","NOT_YET_RECRUITING","Copenhagen","2100","Denmark","DK",{"type":45,"coordinates":103},[104,105],12.56553,55.67594,{"lat":105,"lon":104},[108],{"name":109,"role":31,"phone":12,"phoneExt":12,"email":12},"Thomas Frandsen, MD",{"facility":111,"status":38,"city":112,"state":12,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Turku University Central Hospital","Turku","SF-20520","Finland","FI",{"type":45,"coordinates":117},[118,119],22.26869,60.45148,{"lat":119,"lon":118},[122],{"name":123,"role":31,"phone":12,"phoneExt":12,"email":12},"Päivi Lähteenmäki, MD",{"facility":125,"status":38,"city":126,"state":12,"zip":12,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"CHU Nice","Nice","France","FR",{"type":45,"coordinates":130},[131,132],7.26608,43.70313,{"lat":132,"lon":131},[135],{"name":136,"role":31,"phone":12,"phoneExt":12,"email":12},"Pierre Rohrlich, MD",{"facility":138,"status":38,"city":139,"state":12,"zip":140,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Tel Aviv Sourasky Medical Centre","Tel Aviv","64239","Israel","IL",{"type":45,"coordinates":144},[145,146],34.78057,32.08088,{"lat":146,"lon":145},[149],{"name":150,"role":31,"phone":12,"phoneExt":12,"email":12},"Ronit Elhasid, MD",{"facility":152,"status":38,"city":153,"state":12,"zip":154,"country":155,"countryCode":156,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Ospedale Pediatrico Bambino Gesù","Roma","00165","Italy","IT",{"type":45,"coordinates":158},[159,160],11.10642,44.99364,{"lat":160,"lon":159},[163],{"name":164,"role":31,"phone":12,"phoneExt":12,"email":12},"Franco Locatelli, MD",{"facility":166,"status":38,"city":167,"state":12,"zip":12,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Prinses Máxima Centrum, Lundlaan","Utrecht","Netherlands","NL",{"type":45,"coordinates":171},[172,173],5.12222,52.09083,{"lat":173,"lon":172},[176],{"name":177,"role":31,"phone":12,"phoneExt":12,"email":12},"Peter Hoogerbrugge, MD",{"facility":179,"status":97,"city":180,"state":12,"zip":181,"country":182,"countryCode":183,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Oslo University Hospital","Oslo","0027","Norway","NO",{"type":45,"coordinates":185},[186,187],10.74609,59.91273,{"lat":187,"lon":186},[190],{"name":191,"role":31,"phone":12,"phoneExt":12,"email":12},"Marit Hellebostad, MD",{"facility":193,"status":38,"city":194,"state":12,"zip":195,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Dpt. SCT and Hematology\u002FOncology University Wroclaw","Wroclaw","50354","Poland","PL",{"type":45,"coordinates":199},[200,201],17.03006,51.10286,{"lat":201,"lon":200},[204],{"name":205,"role":31,"phone":12,"phoneExt":12,"email":12},"Ewa Goczynska, MD",{"facility":207,"status":97,"city":208,"state":12,"zip":12,"country":209,"countryCode":210,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Instituto Português de Oncologia de Lisboa","Lisbon","Portugal","PT",{"type":45,"coordinates":212},[213,214],-9.1498,38.72509,{"lat":214,"lon":213},[217],{"name":218,"role":31,"phone":12,"phoneExt":12,"email":12},"Joaquin Duarte, MD",{"facility":220,"status":97,"city":221,"state":12,"zip":222,"country":223,"countryCode":224,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"University Hospital Stockholm","Stockholm","17176","Sweden","SE",{"type":45,"coordinates":226},[227,228],18.06871,59.32938,{"lat":228,"lon":227},[231],{"name":232,"role":31,"phone":12,"phoneExt":12,"email":12},"Petter Svenberg, MD",{"facility":234,"status":97,"city":235,"state":12,"zip":236,"country":237,"countryCode":238,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Royal Manchester Children's Hospital","Manchester","M13 9WL","United Kingdom","UK",{"type":45,"coordinates":240},[241,242],-2.23743,53.48095,{"lat":242,"lon":241},[245],{"name":246,"role":31,"phone":12,"phoneExt":12,"email":12},"Denise Bonney, MD",{"type":28,"investigatorFullName":248,"investigatorTitle":249,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PD Dr. Arend von Stackelberg","Prinicipal Investigator",[251,253,256,259,261,263,265,267,269,271,273,275,277,279,281,283,285,287],{"name":252,"class":6},"Australian & New Zealand Children's Haematology\u002FOncology Group",{"name":254,"class":255},"St. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria)","UNKNOWN",{"name":257,"class":258},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",{"name":260,"class":6},"University Hospital, Motol",{"name":262,"class":6},"Rigshospitalet, Denmark",{"name":264,"class":255},"Turku University Central Hospital (co-sponsor, Finland)",{"name":266,"class":6},"Centre Hospitalier Universitaire de Nice",{"name":268,"class":255},"Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)",{"name":270,"class":255},"Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)",{"name":272,"class":255},"Ospedale Pediatrico Bambino (co-sponsor, Italy)",{"name":274,"class":255},"Prinses Máxima Centrum (Co-Sponsor Netherlands)",{"name":276,"class":255},"Oslo University Hospital (co-sponsor, Norway)",{"name":278,"class":6},"Wroclaw Medical University",{"name":280,"class":255},"Instituto Português de Oncologia de Lisboa (co-sponsor, Portugal)",{"name":282,"class":255},"Karolinska University Hospital Stockholm (co-sponsor, Sweden)",{"name":284,"class":255},"Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)",{"name":286,"class":6},"University Children's Hospital, Zurich",{"name":288,"class":289},"Manchester University NHS Foundation Trust","OTHER_GOV","100331048","phase-2-international-study-for-treatment-of-high-risk-childhood-relapsed-all-2010-100331048",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":300,"type":301},250,"ESTIMATED","INTERVENTIONAL",[304],"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.",[307],"Acute Lymphoblastic Leukemia (ALL)",[297],"2026-03-16",{"date":311,"type":312},"2026-03-17","ACTUAL",{"date":314,"type":312},"2017-09-01",{"date":316,"type":301},"2027-12-31",{"name":5,"class":6},15]