[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100335119":3},{"organization":4,"armGroups":7,"interventions":77,"overallOfficials":146,"centralContacts":151,"locations":161,"responsibleParty":1575,"collaborators":1578,"id":1581,"slug":1582,"hasResults":1583,"nctId":1584,"briefTitle":1585,"officialTitle":1586,"acronym":83,"eligibilityCriteria":1587,"healthyVolunteers":1583,"sex":1588,"minAge":83,"maxAge":1589,"enrollmentInfo":1590,"targetDuration":83,"studyType":1593,"phases":1594,"briefSummary":1596,"conditions":1597,"keywords":1599,"overallStatus":164,"whyStopped":83,"lastUpdateSubmitDate":1608,"lastUpdatePostDateStruct":1609,"startDateStruct":1612,"completionDateStruct":1614,"leadSponsor":1616,"locationsCount":1617},{"fullName":5,"class":6},"University Hospital Schleswig-Holstein","OTHER",[8,25,31,36,40,49,53,57,61,65,69,73],{"label":9,"type":10,"description":11,"interventionNames":12},"pB: early (non-)HR-standard\u002FMR-standard","ACTIVE_COMPARATOR","Induction (5 wks): \"Protocol IA\" with prednisolone, vincristine, daunorubicin, pegaspargase, IT methotrexate (MTX)\n\nConsolidation (6 w\u002F4 w): \"Consolidation extended\" (control arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-mercaptopurine (6-MP), IT MTX, dexamethasone, vincristine, pegaspargase or \"Consolidation short\" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX\n\nExtra-compartment phase (8 wks): \"Protocol M\" with 6-MP, HD-MTX, IT MTX\n\nReinduction (6 wks): \"Protocol II\" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine\n\nMaintenance (until 2 years after initial diagnosis): 6-MP, MTX \\[without preceding blinatumomab (control arm of randomization R-MR)\\]\n\nErwinase is given in case of allergy to pegaspargase.",[13,14,15,16,17,18,19,20,21,22,23,24],"Drug: Cyclophosphamide","Drug: Cytarabine","Drug: Daunorubicin","Drug: Dexamethasone","Drug: Doxorubicin","Drug: 6-Mercaptopurine","Drug: Methotrexate","Drug: Pegaspargase","Drug: Prednisolone","Drug: Tioguanin","Drug: Vincristine","Drug: Erwinase",{"label":26,"type":27,"description":28,"interventionNames":29},"pB: early HR-exp.\u002FMR-standard","EXPERIMENTAL","Induction (5 w): \"Protocol IA\" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX\n\nConsolidation (6 w): \"Consolidation extended+BZM\" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg\u002Fm²\u002Fdose on days 50, 53, 56 and 59)\n\nExtra-compartment phase (8 wks): \"Protocol M\" with 6-MP, HD-MTX, IT MTX\n\nReinduction (6 wks): \"Protocol II\" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine\n\nMaintenance (until 2 yrs after initial diagnosis): 6-MP, MTX \\[without preceding blinatumomab (control arm of randomization R-MR)\\]\n\nErwinase is given in case of allergy to pegaspargase.",[30,13,14,15,16,17,18,19,20,21,22,23,24],"Drug: Bortezomib",{"label":32,"type":27,"description":33,"interventionNames":34},"pB: early (non)HR-standard\u002FMR-exp.","Induction (5 w): \"Protocol IA\" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX\n\nConsolidation (6 w\u002F4 w): \"Consolidation extended\" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or \"Consolidation short\" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX\n\nExtra-compartment phase (8 w): \"Protocol M\" with 6-MP, HD-MTX, IT MTX\n\nReinduction (6 w): \"Protocol II\" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine\n\nBlinatumomab (4 w): 1 cycle blinatumomab given at 15 µg\u002Fm²\u002Fday for 28 days (experimental arm of randomization R-MR)\n\nMaintenance (until 2 yrs after initial diagnosis): 6-MP, MTX\n\nErwinase is given in case of allergy to pegaspargase.",[35,13,14,15,16,17,18,19,20,21,22,23,24],"Drug: Blinatumomab",{"label":37,"type":27,"description":38,"interventionNames":39},"pB: early HR-exp.\u002FMR-exp.","Induction (5 w): \"Protocol IA\" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX\n\nConsolidation (6 w): \"Consolidation extended+BZM\" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg\u002Fm²\u002Fdose on days 50, 53, 56 and 59)\n\nExtra-compartment phase (8 w): \"Protocol M\" with 6-MP, HD-MTX,IT MTX\n\nReinduction (6 weeks): \"Protocol II\" with dexamethasone, vincristine, doxorubicin, PEG-L-asparaginase, IT MTX, cyclophosphamide, tioguanine, cytarabine\n\nBlinatumomab (4 w): 1 cycle blinatumomab given at 15 µg\u002Fm²\u002Fday for 28 days (experimental arm of randomization R-MR)\n\nMaintenance phase (until 2 yrs after initial diagnosis): 6-MP, MTX\n\nErwinase is given in case of allergy to pegaspargase.",[35,30,13,14,15,16,17,18,19,20,21,22,23,24],{"label":41,"type":10,"description":42,"interventionNames":43},"pB: early (non-)HR-standard\u002FHR-standard","Induction (5 w): as in other pB arms\n\nConsolidation (6 w\u002F4 w): \"Consolidation extended\" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT methotrexate, dexamethasone, vincristine, pegaspargase or \"Consolidation short\" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX\n\nIntensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide\n\nReinduction (3x4 w): \"Protocol III\" given 3 times with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine\n\nMaintenance (until 2 yrs after init. diagnosis): 6-MP, MTX\n\nErwinase is given in case pegaspargase allergy. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX).",[13,14,15,44,16,17,45,46,47,18,19,20,21,22,23,48,24],"Drug: Myocet","Drug: Etoposide","Drug: Fludarabine Phosphate","Drug: Ifosfamide","Drug: Vindesine",{"label":50,"type":27,"description":51,"interventionNames":52},"pB: early HR-exp.\u002FHR-standard","Induction (5 w): as in other pB arms\n\nConsolidation (6 w): \"Consolidation extended+BZM\" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg\u002Fm²\u002Fdose on days 50, 53, 56 and 59)\n\nIntensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide\n\nReinduction (3x4 w): as in arm \"pB: early (non-)HR-standard\u002FHR-standard\"\n\nMaintenance (until 2 yrs after initial diagnosis): 6-MP, MTX\n\nErwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)",[13,14,15,44,16,17,45,46,47,18,19,20,21,22,23,48,24],{"label":54,"type":27,"description":55,"interventionNames":56},"pB: early (non-)HR-standard\u002FHR-exp.","Induction (5 w): as in other pB arms\n\nConsolidation (6 w\u002F4 w): \"Consolidation extended\" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or \"Consolidation short\" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX\n\nIntensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg\u002Fm²\u002Fday for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR)\n\nReinduction (3x4 weeks): as in arm \"pB: early (non-)HR-standard\u002FHR-standard\"\n\nMaintenance (until 2 yrs after init. diagnosis): 6-MP, MTX\n\nErwinase is given in case of pegaspargase allergy. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)",[35,13,14,15,44,16,17,18,19,20,21,22,23,24],{"label":58,"type":27,"description":59,"interventionNames":60},"pB: early HR-exp.\u002FHR-exp.","Induction (5 w): as in other pB arms\n\nConsolidation (6 w): \"Consolidation extended+BZM\" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg\u002Fm²\u002Fdose on days 50, 53, 56 and 59)\n\nIntensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg\u002Fm²\u002Fday for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR)\n\nReinduction (3x4 weeks): as in arm \"pB: early (non-)HR-standard\u002FHR-standard\" Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX\n\nErwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)",[35,13,14,15,44,16,17,18,19,20,21,22,23,24],{"label":62,"type":6,"description":63,"interventionNames":64},"pB: early non-HR\u002FSR","Induction (5 w): \"Protocol IA\" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX\n\nConsolidation (4 w): \"Consolidation short\" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX\n\nExtra-compartment phase (8 w): \"Protocol M\" with 6-MP, HD-MTX, IT MTX\n\nReinduction (6 w): \"Protocol II\" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine\n\nMaintenance (until 2 yrs after initial diagnosis): 6-MP, MTX\n\nErwinase is given in case of allergy to pegaspargase.",[13,14,15,16,17,18,19,20,21,22,23,24],{"label":66,"type":10,"description":67,"interventionNames":68},"T: early non-SR-standard\u002F(non-)HR","Induction (5 w): \"Protocol IA-Dexa\" with prednisolone\u002Fdexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or \"Protocol IA-CPM\" with prednisolone instead of dexamethasone and additional CPM\n\nConsolidation (4 w): \"Protocol IB regular\" (control arm in randomization. R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX\n\nnon-HR extra-compartment phase and reinduction: as in arm \"pB: early non-HR\u002FSR\"\n\nHR intensified consolidation and reinduction: as in arm \"pB: early (non-)HR-standard\u002FHR-standard\"\n\nMaintenance (until 2 yrs after initial diagnosis): 6-MP, MTX\n\nErwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)",[13,14,15,44,16,17,45,46,47,18,19,20,21,22,23,48,24],{"label":70,"type":27,"description":71,"interventionNames":72},"T: early non-SR-exp\u002F(non-)HR","Induction (5 w): \"Protocol IA-Dexa\" with prednisolone\u002Fdexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or \"Protocol IA-CPM\" with prednisolone instead of dexamethasone and additional CPM\n\nConsolidation (6 w): \"Protocol IB long\" (experimental arm in randomization R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX\n\nnon-HR extra-compartment phase and reinduction: as in arm \"pB: early non-HR\u002FSR\"\n\nHR intensified consolidation and reinduction: as in arm \"pB: early (non-)HR-standard\u002FHR-standard\"\n\nMaintenance (until 2 yrs after initial diagnosis): 6-MP, MTX\n\nErwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)",[13,14,15,44,16,17,45,46,47,18,19,20,21,22,23,48,24],{"label":74,"type":6,"description":75,"interventionNames":76},"T: early SR\u002Fnon-HR","Induction (5 w): \"Protocol IA-Dexa\" with prednisolone\u002Fdexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX\n\nConsolidation (4 w): \"Protocol IB regular\" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX\n\nExtra-compartment phase (8 w): \"Protocol M\" with 6-MP, HD-MTX, IT MTX\n\nReinduction (6 w): \"Protocol II\" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine\n\nMaintenance (until 2 yrs after initial diagnosis): 6-MP, MTX\n\nErwinase is given in case of allergy to pegaspargase.",[13,14,15,16,17,18,19,20,21,22,23,24],[78,84,88,92,96,100,104,107,110,113,116,119,122,125,128,133,136,139,142],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"DRUG","Blinatumomab","Experimental therapy in randomizations R-HR and R-MR",[32,54,58,37],null,{"type":79,"name":85,"description":86,"armGroupLabels":87,"otherNames":83},"Bortezomib","Experimental therapy in randomization R-eHR",[37,26],{"type":79,"name":89,"description":90,"armGroupLabels":91,"otherNames":83},"Cyclophosphamide","Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":93,"description":94,"armGroupLabels":95,"otherNames":83},"Cytarabine","Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block Myocet-FLA for patients with very high relapse risk",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":97,"description":98,"armGroupLabels":99,"otherNames":83},"Daunorubicin","Part of standard chemotherapy",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":101,"description":102,"armGroupLabels":103,"otherNames":83},"Myocet","Part of intensification block Myocet-FLA for patients with very high relapse risk",[70,66,54,41,58,50],{"type":79,"name":105,"description":98,"armGroupLabels":106,"otherNames":83},"Dexamethasone",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":108,"description":98,"armGroupLabels":109,"otherNames":83},"Doxorubicin",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":111,"description":98,"armGroupLabels":112,"otherNames":83},"Etoposide",[70,66,41,50],{"type":79,"name":114,"description":102,"armGroupLabels":115,"otherNames":83},"Fludarabine Phosphate",[70,66,41,50],{"type":79,"name":117,"description":98,"armGroupLabels":118,"otherNames":83},"Ifosfamide",[70,66,41,50],{"type":79,"name":120,"description":90,"armGroupLabels":121,"otherNames":83},"6-Mercaptopurine",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":123,"description":98,"armGroupLabels":124,"otherNames":83},"Methotrexate",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":126,"description":98,"armGroupLabels":127,"otherNames":83},"Pegaspargase",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":129,"description":98,"armGroupLabels":130,"otherNames":131},"Prednisolone",[74,70,66,32,54,41,9,58,50,37,26,62],[132],"Prednisone",{"type":79,"name":134,"description":98,"armGroupLabels":135,"otherNames":83},"Tioguanin",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":137,"description":98,"armGroupLabels":138,"otherNames":83},"Vincristine",[74,70,66,32,54,41,9,58,50,37,26,62],{"type":79,"name":140,"description":98,"armGroupLabels":141,"otherNames":83},"Vindesine",[70,66,41,50],{"type":79,"name":143,"description":144,"armGroupLabels":145,"otherNames":83},"Erwinase","Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction",[74,70,66,32,54,41,9,58,50,37,26,62],[147],{"name":148,"affiliation":149,"role":150},"Martin Schrappe, MD","Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel","PRINCIPAL_INVESTIGATOR",[152,157],{"name":153,"role":154,"phone":155,"phoneExt":83,"email":156},"Anja Möricke, MD","CONTACT","+4943150020150","a.moericke@pediatrics.uni-kiel.de",{"name":158,"role":154,"phone":159,"phoneExt":83,"email":160},"Lile Bauer","+4943150020152","lile.bauer@uksh.de",[162,177,188,201,212,223,234,245,257,268,279,290,296,307,318,329,346,360,375,387,402,417,432,444,458,473,488,500,511,526,538,550,564,578,590,604,619,634,649,664,679,692,707,720,733,748,761,776,791,806,814,829,844,852,867,882,897,907,922,937,952,967,982,994,1008,1023,1037,1050,1061,1072,1083,1094,1105,1118,1129,1140,1151,1162,1173,1184,1195,1206,1217,1228,1239,1250,1261,1269,1280,1291,1302,1313,1324,1335,1346,1357,1368,1379,1387,1395,1406,1417,1428,1439,1452,1463,1474,1487,1498,1509,1520,1531,1542,1553,1564],{"facility":163,"status":164,"city":165,"state":83,"zip":83,"country":166,"countryCode":167,"cosmosGeoPoint":168,"geoPoint":173,"contacts":174},"Sydney Children's Hospital","RECRUITING","Sydney","Australia","AU",{"type":169,"coordinates":170},"Point",[171,172],151.20732,-33.86785,{"lat":172,"lon":171},[175],{"name":176,"role":154,"phone":83,"phoneExt":83,"email":83},"Draga Barbaric",{"facility":178,"status":164,"city":179,"state":83,"zip":83,"country":166,"countryCode":167,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"The Children's Hospital at Westmead","Westmead",{"type":169,"coordinates":181},[182,183],150.98768,-33.80383,{"lat":183,"lon":182},[186],{"name":187,"role":154,"phone":83,"phoneExt":83,"email":83},"Luciano Dalla-Pozza",{"facility":189,"status":164,"city":190,"state":83,"zip":83,"country":191,"countryCode":192,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Univ.Klinik für Kinder- und Jugendheilkunde Graz","Graz","Austria","AT",{"type":169,"coordinates":194},[195,196],15.44197,47.06733,{"lat":196,"lon":195},[199],{"name":200,"role":154,"phone":83,"phoneExt":83,"email":83},"Martin Benesch",{"facility":202,"status":164,"city":203,"state":83,"zip":83,"country":191,"countryCode":192,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck","Innsbruck",{"type":169,"coordinates":205},[206,207],11.39454,47.26266,{"lat":207,"lon":206},[210],{"name":211,"role":154,"phone":83,"phoneExt":83,"email":83},"Bernhard Meister",{"facility":213,"status":164,"city":214,"state":83,"zip":83,"country":191,"countryCode":192,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Kepler Universitätsklinikum","Linz",{"type":169,"coordinates":216},[217,218],14.28611,48.30639,{"lat":218,"lon":217},[221],{"name":222,"role":154,"phone":83,"phoneExt":83,"email":83},"Georg Ebetsberger",{"facility":224,"status":164,"city":225,"state":83,"zip":83,"country":191,"countryCode":192,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"LKH Salzburg","Salzburg",{"type":169,"coordinates":227},[228,229],13.04399,47.79941,{"lat":229,"lon":228},[232],{"name":233,"role":154,"phone":83,"phoneExt":83,"email":83},"Neil Jones",{"facility":235,"status":164,"city":236,"state":83,"zip":83,"country":191,"countryCode":192,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"St. Anna Kinderspital","Vienna",{"type":169,"coordinates":238},[239,240],16.37208,48.20849,{"lat":240,"lon":239},[243],{"name":244,"role":154,"phone":83,"phoneExt":83,"email":83},"Andishe Attarbaschi",{"facility":246,"status":164,"city":247,"state":83,"zip":83,"country":248,"countryCode":83,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"University Hospital Brno","Brno","Czechia",{"type":169,"coordinates":250},[251,252],16.60796,49.19522,{"lat":252,"lon":251},[255],{"name":256,"role":154,"phone":83,"phoneExt":83,"email":83},"Jaroslav Štěrba",{"facility":258,"status":164,"city":259,"state":83,"zip":83,"country":248,"countryCode":83,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"Regional Hospital České Budějovice","České Budějovice",{"type":169,"coordinates":261},[262,263],14.47434,48.97447,{"lat":263,"lon":262},[266],{"name":267,"role":154,"phone":83,"phoneExt":83,"email":83},"Pavel Timr",{"facility":269,"status":164,"city":270,"state":83,"zip":83,"country":248,"countryCode":83,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"University Hospital Hradec Králové","Hradec Králové",{"type":169,"coordinates":272},[273,274],15.83277,50.20923,{"lat":274,"lon":273},[277],{"name":278,"role":154,"phone":83,"phoneExt":83,"email":83},"Jiří Hak",{"facility":280,"status":164,"city":281,"state":83,"zip":83,"country":248,"countryCode":83,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"University Hospital Olomouc","Olomouc",{"type":169,"coordinates":283},[284,285],17.25175,49.59552,{"lat":285,"lon":284},[288],{"name":289,"role":154,"phone":83,"phoneExt":83,"email":83},"Dagmar 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Weid",{"facility":1499,"status":164,"city":1500,"state":83,"zip":83,"country":1477,"countryCode":1478,"cosmosGeoPoint":1501,"geoPoint":1505,"contacts":1506},"Ospedale San Giovanni Bellinzona","Bellinzona",{"type":169,"coordinates":1502},[1503,1504],9.01703,46.19278,{"lat":1504,"lon":1503},[1507],{"name":1508,"role":154,"phone":83,"phoneExt":83,"email":83},"Pierluigi Brazzola",{"facility":1510,"status":164,"city":1511,"state":83,"zip":83,"country":1477,"countryCode":1478,"cosmosGeoPoint":1512,"geoPoint":1516,"contacts":1517},"Inselspital Bern","Bern",{"type":169,"coordinates":1513},[1514,1515],7.44744,46.94809,{"lat":1515,"lon":1514},[1518],{"name":1519,"role":154,"phone":83,"phoneExt":83,"email":83},"Jochen Rössler",{"facility":1521,"status":164,"city":1522,"state":83,"zip":83,"country":1477,"countryCode":1478,"cosmosGeoPoint":1523,"geoPoint":1527,"contacts":1528},"HUG Hôpitaux Universitaires de Gèneve","Geneva",{"type":169,"coordinates":1524},[1525,1526],6.14569,46.20222,{"lat":1526,"lon":1525},[1529],{"name":1530,"role":154,"phone":83,"phoneExt":83,"email":83},"Frederic Baleydier",{"facility":1532,"status":164,"city":1533,"state":83,"zip":83,"country":1477,"countryCode":1478,"cosmosGeoPoint":1534,"geoPoint":1538,"contacts":1539},"CHUV Centre Hospitalier Universitaire Vaudois","Lausanne",{"type":169,"coordinates":1535},[1536,1537],6.63282,46.516,{"lat":1537,"lon":1536},[1540],{"name":1541,"role":154,"phone":83,"phoneExt":83,"email":83},"Francesco Ceppi",{"facility":1543,"status":164,"city":1544,"state":83,"zip":83,"country":1477,"countryCode":1478,"cosmosGeoPoint":1545,"geoPoint":1549,"contacts":1550},"Luzerner Kantonsspital-Kinderspital Luzern","Lucerne",{"type":169,"coordinates":1546},[1547,1548],8.30635,47.05048,{"lat":1548,"lon":1547},[1551],{"name":1552,"role":154,"phone":83,"phoneExt":83,"email":83},"Freimut Schilling",{"facility":1554,"status":164,"city":1555,"state":83,"zip":83,"country":1477,"countryCode":1478,"cosmosGeoPoint":1556,"geoPoint":1560,"contacts":1561},"Ostschweizer Kinderspital","Sankt Gallen",{"type":169,"coordinates":1557},[1558,1559],9.37477,47.42391,{"lat":1559,"lon":1558},[1562],{"name":1563,"role":154,"phone":83,"phoneExt":83,"email":83},"Jeanette Greiner",{"facility":1565,"status":164,"city":1566,"state":83,"zip":83,"country":1477,"countryCode":1478,"cosmosGeoPoint":1567,"geoPoint":1571,"contacts":1572},"Universitäts-Kinderspital Zürich","Zurich",{"type":169,"coordinates":1568},[1569,1570],8.55,47.36667,{"lat":1570,"lon":1569},[1573],{"name":1574,"role":154,"phone":83,"phoneExt":83,"email":83},"Felix Niggli",{"type":1576,"investigatorFullName":744,"investigatorTitle":1577,"investigatorAffiliation":5,"oldNameTitle":83,"oldOrganization":83},"SPONSOR_INVESTIGATOR","Professor MD, FRCP (Glasg), Chair of Pediatrics I",[1579],{"name":1580,"class":6},"Deutsche Krebshilfe e.V., Bonn (Germany)","100335119","phase-3-treatment-protocol-for-children-and-adolescents-with-acute-lymphoblastic-leukemia---aieop-bfm-all-2017-100335119",false,"NCT03643276","Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017","International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017","Inclusion Criteria:\n\n* newly diagnosed acute lymphoblastic leukemia or\n* newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:\n* biphenotypic with a dominant T or B lineage assignment\n* bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen\n* newly diagnosed acute undifferentiated leukemia\n* age \\\u003C 18 years (up to 17 years and 365 days) at the day of diagnosis\n* patient enrolled in a participating center\n* written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.\n\nExclusion Criteria:\n\n* Ph+ (BCR-ABL1 or t(9;22)-positive) ALL\n* bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset\n* pre-treatment with cytostatic drugs\n* glucocorticoid pre-treatment with ≥ 1 mg\u002Fkg\u002Fd for more than two weeks during the last month before diagnosis\n* treatment started according to another protocol\n* underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…)\n* ALL diagnosed as second malignancy and preceding chemotherapy and\u002For radiotherapy\n* evidence of pregnancy or lactation period\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* participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor\n* live vaccine immunization within 2 weeks before start of protocol treatment","ALL","17 Years",{"count":1591,"type":1592},5000,"ESTIMATED","INTERVENTIONAL",[1595],"PHASE3","The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response (\"minimal residual disease \\[MRD\\] tests\") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse.\n\nThe AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.",[1598],"Acute Lymphoblastic Leukemia, Pediatric",[1600,1601,1602,1603,80,1604,1605,85,1606,1607],"Acute Lymphoblastic Leukemia","Childhood","Pediatric","Immunotherapy","Proteasome Inhibitor","Bispecific antibody","Chemotherapy","Randomized trial","2025-04-03",{"date":1610,"type":1611},"2025-04-06","ACTUAL",{"date":1613,"type":1611},"2018-07-15",{"date":1615,"type":1592},"2028-07-14",{"name":744,"class":6},115]