{"id":"https://openalex.org/W2950899376","doi":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","title":"PB1762 A PHASE III, RANDOMIZED, DOUBLE\u2010BLIND STUDY OF INTENSIVE INDUCTION AND CONSOLIDATION CHEMOTHERAPY PLUS MIDOSTAURIN (PKC412) OR PLACEBO IN NEWLY DIAGNOSED PATIENTS WITH FLT3 MUTATION NEGATIVE AML","display_name":"PB1762 A PHASE III, RANDOMIZED, DOUBLE\u2010BLIND STUDY OF INTENSIVE INDUCTION AND CONSOLIDATION CHEMOTHERAPY PLUS MIDOSTAURIN (PKC412) OR PLACEBO IN NEWLY DIAGNOSED PATIENTS WITH FLT3 MUTATION NEGATIVE AML","publication_year":2019,"publication_date":"2019-06-01","ids":{"openalex":"https://openalex.org/W2950899376","doi":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","mag":"2950899376"},"language":"en","primary_location":{"id":"doi:10.1097/01.hs9.0000565556.35758.82","doi":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","is_oa":true,"landing_page_url":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","pdf_url":null,"source":{"id":"https://openalex.org/S4210211592","display_name":"HemaSphere","issn_l":"2572-9241","issn":["2572-9241"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-2","norway-1","oarl","poland-20","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310318547","host_organization_name":"Wolters Kluwer","host_organization_lineage":["https://openalex.org/P4310318547"],"host_organization_lineage_names":["Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"HemaSphere","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","indexed_in":["crossref","doaj"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5089395073","display_name":"Hartmut D\u00f6hner","orcid":"https://orcid.org/0000-0003-2116-5536","observed_orcids":["https://orcid.org/0000-0003-2116-5536"]},"institutions":[{"id":"https://openalex.org/I4210155144","display_name":"University Hospital Ulm","ror":"https://ror.org/05emabm63","country_code":"DE","type":"healthcare","lineage":["https://openalex.org/I4210155144"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"H. D\u00f6hner","raw_affiliation_strings":["Department of Internal Medicine III University Hospital of Ulm Ulm Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Internal Medicine III University Hospital of Ulm Ulm Germany","institution_ids":["https://openalex.org/I4210155144"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5096734890","display_name":"F. Lo\u2010Coc","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I116067653","display_name":"University of Rome Tor Vergata","ror":"https://ror.org/02p77k626","country_code":"IT","type":"education","lineage":["https://openalex.org/I116067653"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"F. Lo\u2010Coc","raw_affiliation_strings":["Department of Biomedicine and Prevention University Tor Vergata Rome Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biomedicine and Prevention University Tor Vergata Rome Italy","institution_ids":["https://openalex.org/I116067653"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5108882243","display_name":"Gert Jan Ossenkoppele","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I911458345","display_name":"Amsterdam UMC Location Vrije Universiteit Amsterdam","ror":"https://ror.org/00q6h8f30","country_code":"NL","type":"healthcare","lineage":["https://openalex.org/I4210151833","https://openalex.org/I911458345"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"G. Ossenkoppele","raw_affiliation_strings":["Department of Haematology VU University Medical Center Amsterdam Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Haematology VU University Medical Center Amsterdam Netherlands","institution_ids":["https://openalex.org/I911458345"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5025894116","display_name":"Jorge Sierra","orcid":"https://orcid.org/0000-0002-7966-0356","observed_orcids":["https://orcid.org/0000-0002-7966-0356","https://orcid.org/0000-0001-7546-326X"]},"institutions":[{"id":"https://openalex.org/I2801795740","display_name":"Hospital de Sant Pau","ror":"https://ror.org/059n1d175","country_code":"ES","type":"healthcare","lineage":["https://openalex.org/I2801795740"]},{"id":"https://openalex.org/I4210089592","display_name":"Josep Carreras Leukaemia Research Institute","ror":"https://ror.org/00btzwk36","country_code":"ES","type":"facility","lineage":["https://openalex.org/I4210089592","https://openalex.org/I4210144824","https://openalex.org/I4387153040"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"J. Sierra","raw_affiliation_strings":["Hematology Department Hospital de la Santa Creu i Sant Pau and Jos\u00e9 Carreras Leukemia Research Institute Barcelona Spain"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Hematology Department Hospital de la Santa Creu i Sant Pau and Jos\u00e9 Carreras Leukemia Research Institute Barcelona Spain","institution_ids":["https://openalex.org/I2801795740","https://openalex.org/I4210089592"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5057494213","display_name":"Bourras\u2010Rezki Bengoudifa","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1283582996","display_name":"Novartis (Switzerland)","ror":"https://ror.org/02f9zrr09","country_code":"CH","type":"company","lineage":["https://openalex.org/I1283582996"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"B.\u2010R. Bengoudifa","raw_affiliation_strings":["Department of Oncology Novartis Pharma AG Basel Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Oncology Novartis Pharma AG Basel Switzerland","institution_ids":["https://openalex.org/I1283582996"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5089694123","display_name":"Mark J. Levis","orcid":"https://orcid.org/0000-0003-0473-6982","observed_orcids":["https://orcid.org/0000-0003-0473-6982","https://orcid.org/0000-0003-4219-6315"]},"institutions":[{"id":"https://openalex.org/I145311948","display_name":"Johns Hopkins University","ror":"https://ror.org/00za53h95","country_code":"US","type":"education","lineage":["https://openalex.org/I145311948"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"M.J. Levis","raw_affiliation_strings":["Division of Hematologic Malignancies Johns Hopkins University Baltimore"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Hematologic Malignancies Johns Hopkins University Baltimore","institution_ids":["https://openalex.org/I145311948"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5111774456","display_name":"C. Sachs","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1283582996","display_name":"Novartis (Switzerland)","ror":"https://ror.org/02f9zrr09","country_code":"CH","type":"company","lineage":["https://openalex.org/I1283582996"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"C. Sachs","raw_affiliation_strings":["Department of Oncology Novartis Pharma AG Basel Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Oncology Novartis Pharma AG Basel Switzerland","institution_ids":["https://openalex.org/I1283582996"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5091046362","display_name":"Albert Hoenekopp","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1283582996","display_name":"Novartis (Switzerland)","ror":"https://ror.org/02f9zrr09","country_code":"CH","type":"company","lineage":["https://openalex.org/I1283582996"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"A. Hoenekopp","raw_affiliation_strings":["Department of Oncology Novartis Pharma AG Basel Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Oncology Novartis Pharma AG Basel Switzerland","institution_ids":["https://openalex.org/I1283582996"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5071023119","display_name":"Richard Maury Stone","orcid":"https://orcid.org/0000-0002-7526-2633","observed_orcids":["https://orcid.org/0000-0002-7526-2633"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"R.M. Stone","raw_affiliation_strings":["Department of Medical Oncology Dana\u2010Farber/Partners CancerCare Boston United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medical Oncology Dana\u2010Farber/Partners CancerCare Boston United States","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":6,"institutions_distinct_count":7,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":2480,"currency":"USD","value_usd":2480},"apc_paid":{"value":2480,"currency":"USD","value_usd":2480},"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"3","issue":"S1","first_page":"809","last_page":"810"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10309","display_name":"Acute Myeloid Leukemia Research","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10309","display_name":"Acute Myeloid Leukemia Research","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11559","display_name":"Retinoids in leukemia and cellular processes","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11215","display_name":"Chronic Myeloid Leukemia Treatments","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/acute-myeloid-leukemia","display_name":"acute myeloid leukemia","score":0.8730000257492065},{"id":"https://openalex.org/keywords/midostaurin","display_name":"midostaurin","score":0.9430000185966492},{"id":"https://openalex.org/keywords/flt3-itd-mutation","display_name":"FLT3-ITD","score":0.6790000200271606},{"id":"https://openalex.org/keywords/flt3-tkd","display_name":"FLT3-TKD","score":0.8040000200271606},{"id":"https://openalex.org/keywords/idarubicin","display_name":"idarubicin","score":0.6510000228881836},{"id":"https://openalex.org/keywords/cytarabine","display_name":"cytarabine","score":0.9169999957084656},{"id":"https://openalex.org/keywords/consolidation-therapy","display_name":"consolidation therapy","score":0.5479999780654907},{"id":"https://openalex.org/keywords/signal-ratio","display_name":"signal ratio","score":0.5410000085830688},{"id":"https://openalex.org/keywords/risk-stratification","display_name":"risk stratification","score":0.6079999804496765},{"id":"https://openalex.org/keywords/flt3-inhibitors","display_name":"FLT3 inhibitors","score":0.36000001430511475},{"id":"https://openalex.org/keywords/newly-diagnosed-aml","display_name":"newly diagnosed AML","score":0.5879999995231628},{"id":"https://openalex.org/keywords/treatment-efficacy-and-safety","display_name":"treatment efficacy and safety","score":0.5529999732971191},{"id":"https://openalex.org/keywords/central-nervous-system-involvement","display_name":"central nervous system involvement","score":0.4410000145435333}],"concepts":[{"id":"https://openalex.org/C2776481607","wikidata":"https://www.wikidata.org/wiki/Q6842945","display_name":"Midostaurin","level":3,"score":0.856864333152771},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7370747923851013},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.6322082877159119},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.5819034576416016},{"id":"https://openalex.org/C2778336483","wikidata":"https://www.wikidata.org/wiki/Q5090632","display_name":"Chemotherapy regimen","level":3,"score":0.5008454322814941},{"id":"https://openalex.org/C2776694085","wikidata":"https://www.wikidata.org/wiki/Q974135","display_name":"Chemotherapy","level":2,"score":0.4331071674823761},{"id":"https://openalex.org/C2778461978","wikidata":"https://www.wikidata.org/wiki/Q29496","display_name":"Leukemia","level":2,"score":0.4123260974884033}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1097/01.hs9.0000565556.35758.82","doi":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","is_oa":true,"landing_page_url":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","pdf_url":null,"source":{"id":"https://openalex.org/S4210211592","display_name":"HemaSphere","issn_l":"2572-9241","issn":["2572-9241"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-2","norway-1","oarl","poland-20","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310318547","host_organization_name":"Wolters Kluwer","host_organization_lineage":["https://openalex.org/P4310318547"],"host_organization_lineage_names":["Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"HemaSphere","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.1097/01.hs9.0000565556.35758.82","doi":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","is_oa":true,"landing_page_url":"https://doi.org/10.1097/01.hs9.0000565556.35758.82","pdf_url":null,"source":{"id":"https://openalex.org/S4210211592","display_name":"HemaSphere","issn_l":"2572-9241","issn":["2572-9241"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-2","norway-1","oarl","poland-20","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310318547","host_organization_name":"Wolters Kluwer","host_organization_lineage":["https://openalex.org/P4310318547"],"host_organization_lineage_names":["Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"HemaSphere","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.9907000064849854,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2891931626","https://openalex.org/W2588941118","https://openalex.org/W2715749014","https://openalex.org/W2771914151","https://openalex.org/W2463908206","https://openalex.org/W2980055023","https://openalex.org/W2901731162","https://openalex.org/W2889128568","https://openalex.org/W2952543937","https://openalex.org/W3097012557"],"abstract_inverted_index":{"Background:":[0],"Risk":[1],"stratification":[2],"in":[3,22,41,61,134,161,243,448,498],"AML":[4,36,54,71,127,173],"is":[5,19,145,424,461],"evolving":[6],"as":[7,179,396],"a":[8,86,182],"consequence":[9],"of":[10,30,53,65,70,153,301,310,339,348,358,430,490],"characterizing":[11],"cytogenetic":[12],"abnormalities":[13],"and":[14,151,159,247,274,435,488,496],"mutational":[15],"profiling.":[16],"The":[17,143,234],"latter":[18],"especially":[20],"important":[21],"patients":[23,275],"(pts)":[24],"lacking":[25],"karyotypic":[26],"abnormalities1.":[27],"Approximately":[28],"30%":[29],"adult":[31,168],"pts":[32,128,162,169,351,449,499],"with":[33,77,129,156,163,170,224,245,261,272,287,291,296,361,382,450,493,500],"newly":[34,171,451],"diagnosed":[35,172,452],"have":[37],"an":[38,47,57],"activating":[39,58,63],"mutation":[40,49,60],"the":[42,62,66,111,149,337,340,345,428,486],"FLT3":[43,130],"gene,":[44],"usually":[45],"either":[46],"ITD":[48],"(in":[50],"approximately":[51,190],"20%":[52],"pts),":[55],"or":[56,222,241,263,281,289,298,307,322,363,380,390],"point":[59],"loop":[64],"TKD":[67],"(approximately":[68],"6\u20108%":[69],"pts)2.":[72],"FLT3\u2010ITD":[73],"mutations":[74,131],"are":[75,83],"associated":[76],"poor":[78],"prognosis,":[79],"particularly":[80],"when":[81],"they":[82],"present":[84],"at":[85,189,367],"high":[87],"allelic":[88],"ratio":[89],"relative":[90],"to":[91,109,126,147,279,305,336,402,425,432,462],"FLT3\u2010WT":[92,135],"(FLT3\u2010wild":[93],"type)3,4.":[94],"A":[95],"randomized,":[96],"double\u2010blind,":[97],"multi\u2010center,":[98],"placebo\u2010controlled":[99],"phase":[100],"III":[101],"study":[102,144,483],"has":[103],"been":[104],"initiated":[105],"(currently":[106],"enrolling":[107],"pts)":[108],"confirm":[110],"preliminary":[112],"evidence":[113],"from":[114,329],"early":[115],"clinical":[116,122],"trials":[117],"that":[118],"midostaurin":[119,154,239,262,280,317,362,389,431,491],"may":[120],"provide":[121,229],"benefit":[123],"not":[124,415],"only":[125],"but":[132,414],"also":[133],"(Signal":[136],"Ratio":[137],"[SR]":[138],"<":[139,177,455],"0.05)":[140,456],"AML.":[141,165,457,501],"Aims:":[142],"designed":[146],"evaluate":[148,485],"efficacy":[150,487],"safety":[152,489],"combined":[155,492],"intensive":[157,494],"chemotherapy":[158,273,495],"post\u2010consolidation":[160,259,397,442,497],"FLT3\u2010MN":[164,175,453],"Methods:":[166],"502":[167],"demonstrating":[174],"(SR":[176,454],"0.05),":[178],"determined":[180],"by":[181,198,258,439],"central":[183,208],"laboratory":[184],"testing,":[185],"will":[186,195,228,237,270,276,303,315,352,387,410,484],"be":[187,196,238,277],"enrolled":[188],"150\u2010180":[191],"sites":[192],"worldwide.":[193],"Pts":[194,314,370],"stratified":[197],"age":[199],"(<60":[200],"vs.":[201],"\u2265":[202],"60":[203],"years).":[204],"Key":[205,458],"exclusion":[206],"criteria:":[207],"nervous":[209],"system":[210],"(CNS)":[211],"leukemia,":[212,217],"therapy\u2010related":[213],"AML,":[214],"isolated":[215],"extramedullary":[216],"prior":[218,335],"therapy":[219,260,360,409,443],"for":[220,232,249,254,400],"leukemia":[221],"myelodysplasia":[223],"exceptions.":[225],"All":[226],"pts/HCP":[227],"written":[230],"consent":[231],"participation.":[233],"treatment":[235,269,312],"arms":[236],"(PKC412)":[240],"placebo":[242,264,282,323,364,391],"combination":[244],"idarubicin/daunorubicin":[246],"cytarabine":[248,253],"induction":[250,267,302,434],"therapy,":[251,256,350,398,437],"intermediate\u2010dose":[252],"consolidation":[255,311,342,349,436],"followed":[257,438],"(figure).":[265],"In":[266],"phase,":[268],"start":[271,338],"randomized":[278],"on":[283],"day":[284,330],"8.":[285],"Patient":[286],"CR":[288,379],"CRi":[290,381],"adequate":[292,383],"blood":[293,384],"count":[294,385],"recovery":[295,386],"one":[297],"2":[299],"cycles":[300,309,355,404],"move":[304],"4":[306,331],"3":[308],"respectively.":[313],"receive":[316,353,388],"(two":[318],"25":[319],"mg":[320,393],"capsules)":[321,325],"(2":[324],"twice":[326,365,394],"daily":[327,366,395],"orally":[328],"until":[332],"48":[333],"hours":[334],"next":[341],"cycle.":[343],"After":[344],"final":[346],"cycle":[347],"12":[354,403],"(28":[356,405],"days/cycle)":[357],"continuous":[359],"50":[368,392],"mg.":[369],"who":[371],"underwent":[372],"hematopoietic":[373],"cell":[374],"transplantation":[375],"(HCT":[376],"after":[377],"achieving":[378],"continuously,":[399],"up":[401],"days/cycle).":[406],"Post":[407],"HCT":[408],"begin":[411],">30":[412],"days":[413,419],"later":[416],"than":[417],"100":[418],"following":[420],"HCT.":[421],"Primary":[422],"outcome":[423,460],"determine":[426,463],"if":[427,464],"addition":[429],"standard":[433],"single":[440],"agent":[441],"improves":[444,466],"event\u2010free":[445],"survival":[446],"(EFS)":[447],"secondary":[459,469],"Midostaurin":[465],"OS.":[467],"Other":[468],"endpoints":[470],"includes":[471],"Measurable":[472],"Residual":[473],"Disease":[474],"negativity":[475],"(MRD\u2010)":[476],"rate.":[477],"Results:":[478],"\u2010":[479],"Summary/Conclusion:":[480],"This":[481],"multicenter":[482],"image":[502]},"counts_by_year":[],"updated_date":"2026-10-16T09:59:22.235173","created_date":"2019-06-27T00:00:00"}