[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495744":3},{"organization":4,"armGroups":7,"interventions":63,"overallOfficials":103,"centralContacts":104,"locations":111,"responsibleParty":701,"collaborators":103,"id":703,"slug":704,"hasResults":705,"nctId":706,"briefTitle":707,"officialTitle":708,"acronym":103,"eligibilityCriteria":709,"healthyVolunteers":705,"sex":710,"minAge":711,"maxAge":103,"enrollmentInfo":712,"targetDuration":103,"studyType":715,"phases":716,"briefSummary":718,"conditions":719,"keywords":730,"overallStatus":114,"whyStopped":103,"lastUpdateSubmitDate":747,"lastUpdatePostDateStruct":748,"startDateStruct":751,"completionDateStruct":753,"leadSponsor":755,"locationsCount":756},{"fullName":5,"class":6},"Kura Oncology, Inc.","INDUSTRY",[8,16,19,25,28,32,36,40,43,47,51,55,60],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation: Ziftomenib with Venetoclax and Azacitidine in R\u002FR NPM1-m (A-1)","EXPERIMENTAL","Ziftomenib with Venetoclax and Azacitidine in relapsed\u002Frefractory NPM1-m AML patients who have failed at least one prior line of therapy",[13,14,15],"Drug: Ziftomenib","Drug: Venetoclax","Drug: Azacitidine",{"label":17,"type":10,"description":11,"interventionNames":18},"Dose Validation\u002FExpansion: Ziftomenib with Venetoclax and Azacitidine in R\u002FR NPM1-m (A-1)",[13,14,15],{"label":20,"type":10,"description":21,"interventionNames":22},"Dose Escalation: Ziftomenib with 7+3 in 1L NPM1-m\u002FFLT3 wildtype (A-2)","Ziftomenib with 7+3 in newly diagnosed NPM1-m AML patients who are candidates for intensive chemotherapy and must be FLT3 wildtype or ITD ratio \\\u003C0.05",[13,23,24],"Drug: Daunorubicin","Drug: Cytarabine",{"label":26,"type":10,"description":21,"interventionNames":27},"Dose Validation\u002FExpansion: Ziftomenib with 7+3 in 1L NPM1-m\u002FFLT3 wildtype (A-2)",[13,23,24],{"label":29,"type":10,"description":30,"interventionNames":31},"Dose Validation\u002FExpansion: Ziftomenib with Venetoclax in R\u002FR NPM1-m (A-3)","Ziftomenib with Venetoclax in relapsed\u002Frefractory NPM1-m AML patients who have failed at least one prior line of therapy",[13,14],{"label":33,"type":10,"description":34,"interventionNames":35},"Dose Validation\u002FExpansion: Ziftomenib with Venetoclax and Azacitidine in 1L NPM1-m (A-4)","Ziftomenib with Venetoclax and Azacitidine in newly diagnosed NPM1-m AML patients",[13,14,15],{"label":37,"type":10,"description":38,"interventionNames":39},"Dose Escalation: Ziftomenib with Venetoclax and Azacitidine in R\u002FR KMT2A-r (B-1)","Ziftomenib with Venetoclax and Azacitidine in relapsed\u002Frefractory KMT2A-r AML patients who have failed at least one prior line of therapy",[13,14,15],{"label":41,"type":10,"description":38,"interventionNames":42},"Dose Validation\u002FExpansion: Ziftomenib with Venetoclax and Azacitidine in R\u002FR KMT2A-r (B-1)",[13,14,15],{"label":44,"type":10,"description":45,"interventionNames":46},"Dose Escalation: Ziftomenib with 7+3 in 1L KMT2A-r (B-2)","Ziftomenib with 7+3 in newly diagnosed KMT2A-r AML patients who are candidates for intensive chemotherapy",[13,23,24],{"label":48,"type":10,"description":49,"interventionNames":50},"Dose Validation\u002FExpansion: Ziftomenib with 7+3 in 1L KMT2A-r (B-2)","Ziftomenib with 7+3 in newly diagnosed KMT2A-r AML patients who are candidates for intensive therapy",[13,23,24],{"label":52,"type":10,"description":53,"interventionNames":54},"Dose Validation\u002FExpansion: Ziftomenib with Venetoclax + Azacitidine in 1L KMT2A-r (B-3)","Ziftomenib with Venetoclax and Azacitidine in newly diagnosed KMT2A-r AML patients",[13,14,15],{"label":56,"type":10,"description":57,"interventionNames":58},"Dose Escalation: Ziftomenib with 7+3+quizartinib in 1L NPM1-m\u002FFLT3-ITD+ AML patients (C-1)","Ziftomenib with 7+3 and quizartinib in newly diagnosed NPM1-m and FLT3-ITD+ (with allelic ratio ≥0.05) AML patients who are candidates for IC and eligible to receive FLT3-targeted therapy",[13,23,24,59],"Drug: Quizartinib",{"label":61,"type":10,"description":57,"interventionNames":62},"Dose Validation\u002FExpansion: Ziftomenib with 7+3+quizartinib in 1L NPM1-m\u002FFLT3-ITD+ AML patients (C-1)",[13,23,24,59],[64,71,77,84,91,98],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DRUG","Ziftomenib","Oral Administration",[44,20,56,37,9,48,26,61,52,33,41,17,29],[70],"KO-539",{"type":65,"name":72,"description":67,"armGroupLabels":73,"otherNames":74},"Venetoclax",[37,9,52,33,41,17,29],[75,76],"Venclexta","Venclyxto",{"type":65,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"Azacitidine","Subcutaneous or Intravenous Administration",[37,9,52,33,41,17],[82,83],"Azadine","Vidaza",{"type":65,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Daunorubicin","Intravenous Administration",[44,20,56,48,26,61],[89,90],"Cerubidine","daunomycin",{"type":65,"name":92,"description":86,"armGroupLabels":93,"otherNames":94},"Cytarabine",[44,20,56,48,26,61],[95,96,97],"cytosine arabinoside (ara-C)","Cytosar-U","Tarabine PFS",{"type":65,"name":99,"description":67,"armGroupLabels":100,"otherNames":101},"Quizartinib",[56,61],[102],"Vanflyta",null,[105],{"name":106,"role":107,"phone":108,"phoneExt":109,"email":110},"Kura Medical Information","CONTACT","844-KURAONC","(844-587-2662)","medinfo@kuraoncology.com",[112,130,144,158,169,183,193,207,222,234,248,261,275,284,298,313,327,337,352,366,381,394,409,423,433,444,459,472,486,498,508,519,533,547,561,572,585,599,616,630,644,658,672,687],{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"Mayo Clinic - Phoenix","RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":121,"coordinates":122},"Point",[123,124],-112.07404,33.44838,{"lat":124,"lon":123},[127],{"name":128,"role":107,"phone":129,"phoneExt":103,"email":103},"Clinical Trials Referral Office","855-776-0015",{"facility":131,"status":114,"city":132,"state":133,"zip":134,"country":118,"countryCode":119,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Moores UC San Diego Cancer Center","La Jolla","California","92093",{"type":121,"coordinates":136},[137,138],-117.2742,32.84727,{"lat":138,"lon":137},[141],{"name":142,"role":107,"phone":103,"phoneExt":103,"email":143},"Krisma Montalvo","k1montalvo@health.ucsd.edu",{"facility":145,"status":114,"city":146,"state":133,"zip":147,"country":118,"countryCode":119,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"USC \u002F Norris Comprehensive Cancer Center","Los Angeles","90033",{"type":121,"coordinates":149},[150,151],-118.24368,34.05223,{"lat":151,"lon":150},[154],{"name":155,"role":107,"phone":156,"phoneExt":103,"email":157},"Christine Duran","323-865-0371","duran_c@med.usc.edu",{"facility":159,"status":114,"city":146,"state":133,"zip":160,"country":118,"countryCode":119,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"UCLA - Bowyer Oncology Center","90095",{"type":121,"coordinates":162},[150,151],{"lat":151,"lon":150},[165],{"name":166,"role":107,"phone":167,"phoneExt":103,"email":168},"Bruck Habtemariam","310-794-0242","bhabtemariam@mednet.ucla.edu",{"facility":170,"status":114,"city":171,"state":133,"zip":172,"country":118,"countryCode":119,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"UC Irvine Health Chao Family Comprehensive Cancer Center","Orange","92868",{"type":121,"coordinates":174},[175,176],-117.85311,33.78779,{"lat":176,"lon":175},[179],{"name":180,"role":107,"phone":181,"phoneExt":103,"email":182},"Research Line","877-827-8839","ucstudy@hs.uci.edu",{"facility":184,"status":114,"city":185,"state":186,"zip":187,"country":118,"countryCode":119,"cosmosGeoPoint":188,"geoPoint":192,"contacts":103},"University of Colorado","Aurora","Colorado","80045",{"type":121,"coordinates":189},[190,191],-104.83192,39.72943,{"lat":191,"lon":190},{"facility":194,"status":114,"city":195,"state":186,"zip":196,"country":118,"countryCode":119,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Colorado Blood Cancer Institute","Denver","80218",{"type":121,"coordinates":198},[199,200],-104.9847,39.73915,{"lat":200,"lon":199},[203],{"name":204,"role":107,"phone":205,"phoneExt":103,"email":206},"Patient Clinic","720-754-4800","PSLMDLCBCINewClinicPatient@HCAHealthcare.com",{"facility":208,"status":114,"city":209,"state":210,"zip":211,"country":118,"countryCode":119,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Yale Cancer Center and Smilow Cancer Hospital","New Haven","Connecticut","06510",{"type":121,"coordinates":213},[214,215],-72.92816,41.30815,{"lat":215,"lon":214},[218],{"name":219,"role":107,"phone":220,"phoneExt":103,"email":221},"Farah Fasihuddin","203-737-3472","farah.fasihuddin@yale.edu",{"facility":223,"status":114,"city":224,"state":225,"zip":226,"country":118,"countryCode":119,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Mayo Clinic Jacksonville","Jacksonville","Florida","32224",{"type":121,"coordinates":228},[229,230],-81.65565,30.33218,{"lat":230,"lon":229},[233],{"name":128,"role":107,"phone":129,"phoneExt":103,"email":103},{"facility":235,"status":114,"city":236,"state":237,"zip":238,"country":118,"countryCode":119,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Emory Healthcare - The Emory Clinic","Atlanta","Georgia","30308",{"type":121,"coordinates":240},[241,242],-84.38798,33.749,{"lat":242,"lon":241},[245],{"name":246,"role":107,"phone":103,"phoneExt":103,"email":247},"Gigi Stoneback","gissela.blanco.stoneback@emory.edu",{"facility":249,"status":114,"city":250,"state":237,"zip":251,"country":118,"countryCode":119,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Georgia Cancer Center at Augusta University","Augusta","30912",{"type":121,"coordinates":253},[254,255],-81.97484,33.47097,{"lat":255,"lon":254},[258],{"name":259,"role":107,"phone":103,"phoneExt":103,"email":260},"Amanda Spires","amspires@augusta.edu",{"facility":262,"status":114,"city":263,"state":264,"zip":265,"country":118,"countryCode":119,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Robert H. Lurie Comprehensive Cancer Center of Northwestern University","Chicago","Illinois","60611",{"type":121,"coordinates":267},[268,269],-87.65005,41.85003,{"lat":269,"lon":268},[272],{"name":103,"role":107,"phone":273,"phoneExt":103,"email":274},"312-695-9367","cancer@northwestern.edu",{"facility":276,"status":114,"city":277,"state":264,"zip":278,"country":118,"countryCode":119,"cosmosGeoPoint":279,"geoPoint":283,"contacts":103},"Loyola University Medical Center","Maywood","60153",{"type":121,"coordinates":280},[281,282],-87.84312,41.8792,{"lat":282,"lon":281},{"facility":285,"status":114,"city":286,"state":287,"zip":288,"country":118,"countryCode":119,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"University of Iowa Hospitals & Clinics","Iowa City","Iowa","52242",{"type":121,"coordinates":290},[291,292],-91.53017,41.66113,{"lat":292,"lon":291},[295],{"name":296,"role":107,"phone":103,"phoneExt":103,"email":297},"Cena Jones","cena-jones@uiowa.edu",{"facility":299,"status":114,"city":300,"state":301,"zip":302,"country":118,"countryCode":119,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"The University of Kansas Medical Center Research Institute","Fairway","Kansas","66205",{"type":121,"coordinates":304},[305,306],-94.6319,39.02223,{"lat":306,"lon":305},[309],{"name":310,"role":107,"phone":311,"phoneExt":103,"email":312},"Thania Medrano","913-945-7552","CTNurseNav@kumc.edu",{"facility":314,"status":114,"city":315,"state":316,"zip":317,"country":118,"countryCode":119,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"University of Kentucky Markey Cancer Center","Louisville","Kentucky","40202",{"type":121,"coordinates":319},[320,321],-85.75941,38.25424,{"lat":321,"lon":320},[324],{"name":325,"role":107,"phone":103,"phoneExt":103,"email":326},"Ashley Walton-Robbins","Ashley.Walton-Robbins@uky.edu",{"facility":328,"status":114,"city":315,"state":316,"zip":329,"country":118,"countryCode":119,"cosmosGeoPoint":330,"geoPoint":332,"contacts":333},"Norton Cancer Institute - St. Matthews","40207",{"type":121,"coordinates":331},[320,321],{"lat":321,"lon":320},[334],{"name":103,"role":107,"phone":335,"phoneExt":103,"email":336},"502-899-3366","leukemia-NCIResearch@nortonhealthcare.org",{"facility":338,"status":114,"city":339,"state":340,"zip":341,"country":118,"countryCode":119,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"Ochsner MD Anderson Cancer Center","Jefferson","Louisiana","70121",{"type":121,"coordinates":343},[344,345],-90.15313,29.96604,{"lat":345,"lon":344},[348],{"name":349,"role":107,"phone":350,"phoneExt":103,"email":351},"Amanda Woolery, RN","504-842-0275","amanda.woolery@ochsner.org",{"facility":353,"status":114,"city":354,"state":355,"zip":356,"country":118,"countryCode":119,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Johns Hopkins School of Medicine","Baltimore","Maryland","21205",{"type":121,"coordinates":358},[359,360],-76.61219,39.29038,{"lat":360,"lon":359},[363],{"name":364,"role":107,"phone":103,"phoneExt":103,"email":365},"I. Gojo","igojo1@jhmi.edu",{"facility":367,"status":114,"city":368,"state":369,"zip":370,"country":118,"countryCode":119,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":121,"coordinates":372},[373,374],-71.05977,42.35843,{"lat":374,"lon":373},[377],{"name":378,"role":107,"phone":379,"phoneExt":103,"email":380},"Christine Connelly","617-724-1124","cconnolly1@mgh.harvard.edu",{"facility":382,"status":114,"city":383,"state":369,"zip":384,"country":118,"countryCode":119,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"UMass Chan Medical School","Worcester","01655",{"type":121,"coordinates":386},[387,388],-71.80229,42.26259,{"lat":388,"lon":387},[391],{"name":103,"role":107,"phone":392,"phoneExt":103,"email":393},"508-856-3216","Cancer.research@umassmed.edu",{"facility":395,"status":114,"city":396,"state":397,"zip":398,"country":118,"countryCode":119,"cosmosGeoPoint":399,"geoPoint":403,"contacts":404},"University of Michigan Comprehensive Cancer Center","Ann Arbor","Michigan","48109",{"type":121,"coordinates":400},[401,402],-83.74088,42.27756,{"lat":402,"lon":401},[405],{"name":406,"role":107,"phone":407,"phoneExt":103,"email":408},"Cancer AnswerLine","800-865-1125","CancerAnswerLine@med.umich.edu",{"facility":410,"status":114,"city":411,"state":397,"zip":412,"country":118,"countryCode":119,"cosmosGeoPoint":413,"geoPoint":417,"contacts":418},"Karmanos Cancer Institute","Detroit","48201",{"type":121,"coordinates":414},[415,416],-83.04575,42.33143,{"lat":416,"lon":415},[419],{"name":420,"role":107,"phone":421,"phoneExt":103,"email":422},"Carmen Rush","800-527-6266","rushc@karmanos.org",{"facility":424,"status":114,"city":425,"state":426,"zip":427,"country":118,"countryCode":119,"cosmosGeoPoint":428,"geoPoint":432,"contacts":103},"University of Minnesota","Minneapolis","Minnesota","55455",{"type":121,"coordinates":429},[430,431],-93.26384,44.97997,{"lat":431,"lon":430},{"facility":434,"status":114,"city":435,"state":426,"zip":436,"country":118,"countryCode":119,"cosmosGeoPoint":437,"geoPoint":441,"contacts":442},"Mayo Clinic - Rochester","Rochester","55905",{"type":121,"coordinates":438},[439,440],-92.4699,44.02163,{"lat":440,"lon":439},[443],{"name":128,"role":107,"phone":129,"phoneExt":103,"email":103},{"facility":445,"status":114,"city":446,"state":447,"zip":448,"country":118,"countryCode":119,"cosmosGeoPoint":449,"geoPoint":453,"contacts":454},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":121,"coordinates":450},[451,452],-74.04347,40.88593,{"lat":452,"lon":451},[455],{"name":456,"role":107,"phone":457,"phoneExt":103,"email":458},"Oncology Clinical Research Referral Office","551-996-1777","OncologyResearchReferral@hmhn.org",{"facility":460,"status":114,"city":461,"state":447,"zip":462,"country":118,"countryCode":119,"cosmosGeoPoint":463,"geoPoint":467,"contacts":468},"Rutgers Cancer Institute","New Brunswick","08903",{"type":121,"coordinates":464},[465,466],-74.45182,40.48622,{"lat":466,"lon":465},[469],{"name":470,"role":107,"phone":103,"phoneExt":103,"email":471},"Anita Trupiano","ar2069@cinj.rutgers.edu",{"facility":473,"status":114,"city":474,"state":475,"zip":476,"country":118,"countryCode":119,"cosmosGeoPoint":477,"geoPoint":481,"contacts":482},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14203",{"type":121,"coordinates":478},[479,480],-78.87837,42.88645,{"lat":480,"lon":479},[483],{"name":103,"role":107,"phone":484,"phoneExt":103,"email":485},"877-275-7724","askrpci@roswellpark.org",{"facility":487,"status":114,"city":475,"state":475,"zip":488,"country":118,"countryCode":119,"cosmosGeoPoint":489,"geoPoint":493,"contacts":494},"New York - Presbyterian \u002F Weill Cornell Medicine","10021",{"type":121,"coordinates":490},[491,492],-74.00597,40.71427,{"lat":492,"lon":491},[495],{"name":496,"role":107,"phone":103,"phoneExt":103,"email":497},"Tania J Curcio","tjc9003@med.cornell.edu",{"facility":499,"status":114,"city":475,"state":475,"zip":500,"country":118,"countryCode":119,"cosmosGeoPoint":501,"geoPoint":503,"contacts":504},"Mount Sinai - Ruttenberg Treatment Center","10029",{"type":121,"coordinates":502},[491,492],{"lat":492,"lon":491},[505],{"name":506,"role":107,"phone":103,"phoneExt":103,"email":507},"Tina Czaplinska","tina.czaplinska@mssm.edu",{"facility":509,"status":114,"city":475,"state":475,"zip":510,"country":118,"countryCode":119,"cosmosGeoPoint":511,"geoPoint":513,"contacts":514},"Columbia University Medical Center","10032",{"type":121,"coordinates":512},[491,492],{"lat":492,"lon":491},[515],{"name":516,"role":107,"phone":517,"phoneExt":103,"email":518},"Research Nurse Navigator","212-342-5162","cancerclinicaltrials@cumc.columbia.edu",{"facility":520,"status":114,"city":521,"state":475,"zip":522,"country":118,"countryCode":119,"cosmosGeoPoint":523,"geoPoint":527,"contacts":528},"Stony Brook University Hospital","Stony Brook","11794",{"type":121,"coordinates":524},[525,526],-73.14094,40.92565,{"lat":526,"lon":525},[529],{"name":530,"role":107,"phone":531,"phoneExt":103,"email":532},"Pushpa Talanki","631-638-0815","Pushpa.Talanki@stonybrookmedicine.edu",{"facility":534,"status":114,"city":535,"state":536,"zip":537,"country":118,"countryCode":119,"cosmosGeoPoint":538,"geoPoint":542,"contacts":543},"Duke Blood Cancer Center","Durham","North Carolina","27705",{"type":121,"coordinates":539},[540,541],-78.89862,35.99403,{"lat":541,"lon":540},[544],{"name":545,"role":107,"phone":103,"phoneExt":103,"email":546},"Quinna Lawson","quinna.marshburn@duke.edu",{"facility":548,"status":114,"city":549,"state":550,"zip":551,"country":118,"countryCode":119,"cosmosGeoPoint":552,"geoPoint":556,"contacts":557},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",{"type":121,"coordinates":553},[554,555],-81.69541,41.4995,{"lat":555,"lon":554},[558],{"name":559,"role":107,"phone":103,"phoneExt":103,"email":560},"Sarah Gollwitzer","Sarah.Gollwitzer@UHhospitals.org",{"facility":562,"status":114,"city":549,"state":550,"zip":563,"country":118,"countryCode":119,"cosmosGeoPoint":564,"geoPoint":566,"contacts":567},"Cleveland Clinic Taussig Cancer Institute","44195",{"type":121,"coordinates":565},[554,555],{"lat":555,"lon":554},[568],{"name":569,"role":107,"phone":570,"phoneExt":103,"email":571},"Cancer Answer Line","866-223-8100","ADVANIA@ccf.org",{"facility":573,"status":114,"city":574,"state":550,"zip":575,"country":118,"countryCode":119,"cosmosGeoPoint":576,"geoPoint":580,"contacts":581},"The James Cancer Hospital and Solove Research Institute","Columbus","43210",{"type":121,"coordinates":577},[578,579],-82.99879,39.96118,{"lat":579,"lon":578},[582],{"name":583,"role":107,"phone":103,"phoneExt":103,"email":584},"Hanna Cordes","Hanna.cordes@osumc.edu",{"facility":586,"status":114,"city":587,"state":588,"zip":589,"country":118,"countryCode":119,"cosmosGeoPoint":590,"geoPoint":594,"contacts":595},"OU Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73104",{"type":121,"coordinates":591},[592,593],-97.51643,35.46756,{"lat":593,"lon":592},[596],{"name":597,"role":107,"phone":103,"phoneExt":103,"email":598},"Cynthia Lowery","Cynthia-Lowery@ouhsc.edu",{"facility":600,"status":114,"city":601,"state":602,"zip":603,"country":118,"countryCode":119,"cosmosGeoPoint":604,"geoPoint":608,"contacts":609},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":121,"coordinates":605},[606,607],-75.16362,39.95238,{"lat":607,"lon":606},[610,613],{"name":611,"role":107,"phone":103,"phoneExt":103,"email":612},"Jessica Ritter","Jessica.Ritter@pennmedicine.upenn.edu",{"name":614,"role":107,"phone":103,"phoneExt":103,"email":615},"Camilla Ludlow","camila.ludlow@pennmedicine.upenn.edu",{"facility":617,"status":114,"city":618,"state":619,"zip":620,"country":118,"countryCode":119,"cosmosGeoPoint":621,"geoPoint":625,"contacts":626},"TriStar Bone Marrow Transplant","Nashville","Tennessee","37203",{"type":121,"coordinates":622},[623,624],-86.78444,36.16589,{"lat":624,"lon":623},[627],{"name":628,"role":107,"phone":629,"phoneExt":103,"email":103},"Ask Sarah","844-482-4812",{"facility":631,"status":114,"city":632,"state":633,"zip":634,"country":118,"countryCode":119,"cosmosGeoPoint":635,"geoPoint":639,"contacts":640},"Sarah Cannon Research Institute - St. David's South Austin Medical Center \u002F Texas Oncology South Austin","Austin","Texas","78704",{"type":121,"coordinates":636},[637,638],-97.74306,30.26715,{"lat":638,"lon":637},[641],{"name":642,"role":107,"phone":103,"phoneExt":103,"email":643},"Amy Hammack","amy.hammack@sarahcannon.com",{"facility":645,"status":114,"city":646,"state":633,"zip":647,"country":118,"countryCode":119,"cosmosGeoPoint":648,"geoPoint":652,"contacts":653},"UT Southwestern - Simmons Cancer Center","Dallas","75235",{"type":121,"coordinates":649},[650,651],-96.80667,32.78306,{"lat":651,"lon":650},[654],{"name":655,"role":107,"phone":656,"phoneExt":103,"email":657},"Phase I Team","214-648-7097","HemeTeam@groups.utsouthwestern.edu",{"facility":659,"status":114,"city":660,"state":633,"zip":661,"country":118,"countryCode":119,"cosmosGeoPoint":662,"geoPoint":666,"contacts":667},"MD Anderson Cancer Center","Houston","77030",{"type":121,"coordinates":663},[664,665],-95.36327,29.76328,{"lat":665,"lon":664},[668],{"name":669,"role":107,"phone":670,"phoneExt":103,"email":671},"Ramya Ganesh","713-792-5640","rganesh@mdanderson.org",{"facility":673,"status":114,"city":674,"state":675,"zip":676,"country":118,"countryCode":119,"cosmosGeoPoint":677,"geoPoint":681,"contacts":682},"University of Wisconsin Hospital and Clinics","Madison","Wisconsin","53792",{"type":121,"coordinates":678},[679,680],-89.40123,43.07305,{"lat":680,"lon":679},[683],{"name":684,"role":107,"phone":685,"phoneExt":103,"email":686},"UW Cancer Connect","800-622-8922","clinicaltrials@cancer.wisc.edu",{"facility":688,"status":114,"city":689,"state":675,"zip":690,"country":118,"countryCode":119,"cosmosGeoPoint":691,"geoPoint":695,"contacts":696},"Medical College of Wisconsin Cancer Center","Milwaukee","53226",{"type":121,"coordinates":692},[693,694],-87.90647,43.0389,{"lat":694,"lon":693},[697],{"name":698,"role":107,"phone":699,"phoneExt":103,"email":700},"Medical College of WI Cancer Center Clinical Trials Office","414-805-8900","cccto@mcw.edu",{"type":702,"investigatorFullName":103,"investigatorTitle":103,"investigatorAffiliation":103,"oldNameTitle":103,"oldOrganization":103},"SPONSOR","100495744","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-ziftomenib-in-combination-with-venetoclaxazacitidine-venetoclax-73-or-73quizartinib-in-patients-with-aml-100495744",false,"NCT05735184","A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax\u002FAzacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML","Phase 1 Study of Venetoclax\u002FAzacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine\u002FDaunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed\u002Frefractory AML\n\n  * Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Adequate liver, renal, and cardiac function according to protocol defined criteria\n* A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or use a double barrier method of contraception from the time of screening through 180 days following the last dose of study intervention\n\n  * Female patients of childbearing potential who receive quizartinib in Arm C should use a highly effective method of contraception during quizartinib treatment and for 7 months after the last dose\n\nKey Exclusion Criteria:\n\n* Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia\n* Known history of BCR-ABL alteration\n* Advanced malignant hepatic tumor\n* Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery\n* Active central nervous system (CNS) involvement by AML.\n* Clinical signs\u002Fsymptoms of leukostasis or WBC \\> 25,000 \u002F microliter. Hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine if used per institutional SOC for control of leukocytosis are permitted to meet this criterion\n* Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia\n* Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection\n* For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia\n* For relapsed\u002Frefractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \\\u003C 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug\n* Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol\n* Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)\n\n  * Arm A and Arm B: \\>480 ms on triplicate ECGs\n  * Arm C: \\>450 ms on triplicate ECGs\n* Uncontrolled infection\n* Women who are pregnant or lactating\n* An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled\u002Fprogressing\n* Patients who have active GVHD requiring \\>0.5 mg\u002Fkg prednisone or any new or increase in immunosuppressants in the prior 2 weeks for GVHD treatment","ALL","18 Years",{"count":713,"type":714},420,"ESTIMATED","INTERVENTIONAL",[717],"PHASE1","Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.\n\nThis protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.\n\nThe purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.",[720,721,722,723,724,725,726,727,728,729],"Acute Myeloid Leukemia","Mixed Lineage Leukemia Gene Mutation","Refractory AML","AML With Mutated NPM1","Acute Myeloid Leukemia Recurrent","Acute Myeloid Leukemia, in Relapse","NPM1 Mutation","KMT2Ar","Myeloid Sarcoma","Nucleophosmin 1-mutated Acute Myeloid Leukemia",[731,732,733,734,735,736,737,738,739,740,741,742,743,744,745,722,725,746],"Leukemia","Myeloid","AML","Hematological malignancy","KMT2A","NPM1","Menin","Acute Leukemia","Newly diagnosed AML","Untreated AML","venetoclax","cytarabine","daunorubicin","KMT2A-r","NPM1 mutation","quizartinib","2026-03-11",{"date":749,"type":750},"2026-03-13","ACTUAL",{"date":752,"type":750},"2023-07-18",{"date":754,"type":714},"2030-04",{"name":5,"class":6},44]