[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551159":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":50,"centralContacts":51,"locations":57,"responsibleParty":451,"collaborators":50,"id":453,"slug":454,"hasResults":455,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":455,"sex":461,"minAge":462,"maxAge":50,"enrollmentInfo":463,"targetDuration":50,"studyType":466,"phases":467,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":60,"whyStopped":50,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":483},{"fullName":5,"class":6},"Stemline Therapeutics, Inc.","INDUSTRY",[8,16,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 - Tagraxofusp (9 μg\u002Fkg\u002Fday)","EXPERIMENTAL","Participants will receive tagraxofusp in combination with venetoclax and azacitidine.",[13,14,15],"Drug: Tagraxofusp","Drug: Venetoclax","Drug: Azacitidine",{"label":17,"type":10,"description":11,"interventionNames":18},"Part 1 - Tagraxofusp (12 μg\u002Fkg\u002Fday)",[13,14,15],{"label":20,"type":10,"description":21,"interventionNames":22},"Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type","Participants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine.",[13,14,15],{"label":24,"type":10,"description":25,"interventionNames":26},"Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated","Participants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine.",[13,14,15],[28,36,43],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Tagraxofusp","Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.",[17,9,24,20],[34,35],"Tag","Elzonris",{"type":29,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Venetoclax","Venetoclax will be administered as an oral tablet (400 milligrams \\[mg\\]) daily, with ramp up in Cycle 1, and should be continued at target dose (400 mg) for the remainder of Cycle 1 and subsequent cycles of 28 days each.",[17,9,24,20],[41,42],"Ven","Venclexta",{"type":29,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Azacitidine","Azacitidine will be administered subcutaneously or by intravenous infusion (75 milligrams\u002Fsquare meter) over 7 days of each 28-day cycle, per institutional guidelines\u002Fphysician choice.",[17,9,24,20],[48,49],"Aza","Vidaza",null,[52],{"name":53,"role":54,"phone":55,"phoneExt":50,"email":56},"Stemline Trials","CONTACT","1-877-332-7961","clinicaltrials@menarinistemline.com",[58,76,88,101,113,126,139,147,156,169,182,195,207,220,232,243,252,265,276,289,302,315,323,336,348,363,376,389,402,414,426,438],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"University of California, Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-118.24368,34.05223,{"lat":70,"lon":69},[73],{"name":74,"role":75,"phone":50,"phoneExt":50,"email":50},"Gary Schiller, MD","PRINCIPAL_INVESTIGATOR",{"facility":77,"status":60,"city":78,"state":62,"zip":79,"country":64,"countryCode":65,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Stanford Health Care","Stanford","94305",{"type":67,"coordinates":81},[82,83],-122.16608,37.42411,{"lat":83,"lon":82},[86],{"name":87,"role":75,"phone":50,"phoneExt":50,"email":50},"Gabriel Mannis, MD",{"facility":89,"status":60,"city":90,"state":91,"zip":92,"country":64,"countryCode":65,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"University of Miami","Miami","Florida","33136",{"type":67,"coordinates":94},[95,96],-80.19366,25.77427,{"lat":96,"lon":95},[99],{"name":100,"role":75,"phone":50,"phoneExt":50,"email":50},"Namrata Chandhok, MD",{"facility":102,"status":60,"city":103,"state":91,"zip":104,"country":64,"countryCode":65,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"AdventHealth Cancer Institute","Orlando","32804",{"type":67,"coordinates":106},[107,108],-81.37924,28.53834,{"lat":108,"lon":107},[111],{"name":112,"role":75,"phone":50,"phoneExt":50,"email":50},"Shahram Mori, MD, PhD",{"facility":114,"status":60,"city":115,"state":116,"zip":117,"country":64,"countryCode":65,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"University of Chicago","Chicago","Illinois","60637",{"type":67,"coordinates":119},[120,121],-87.65005,41.85003,{"lat":121,"lon":120},[124],{"name":125,"role":75,"phone":50,"phoneExt":50,"email":50},"Anand Patel, MD",{"facility":127,"status":60,"city":128,"state":129,"zip":130,"country":64,"countryCode":65,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Dana Farber Cancer Institute (DFCI)","Boston","Massachusetts","02114",{"type":67,"coordinates":132},[133,134],-71.05977,42.35843,{"lat":134,"lon":133},[137],{"name":138,"role":75,"phone":50,"phoneExt":50,"email":50},"Andrew A Lane, MD, PhD",{"facility":140,"status":60,"city":128,"state":129,"zip":130,"country":64,"countryCode":65,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"Massachusetts General Hospital",{"type":67,"coordinates":142},[133,134],{"lat":134,"lon":133},[145],{"name":146,"role":75,"phone":50,"phoneExt":50,"email":50},"Amir Fathi, MD",{"facility":148,"status":60,"city":128,"state":129,"zip":149,"country":64,"countryCode":65,"cosmosGeoPoint":150,"geoPoint":152,"contacts":153},"Beth Israel Deaconess Medical Center","02215",{"type":67,"coordinates":151},[133,134],{"lat":134,"lon":133},[154],{"name":155,"role":75,"phone":50,"phoneExt":50,"email":50},"Malgorzata McMasters, MD",{"facility":157,"status":60,"city":158,"state":159,"zip":160,"country":64,"countryCode":65,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Henry Ford Health System Brigitte Harris Cancer Pavillion","Detroit","Michigan","48202",{"type":67,"coordinates":162},[163,164],-83.04575,42.33143,{"lat":164,"lon":163},[167],{"name":168,"role":75,"phone":50,"phoneExt":50,"email":50},"Christopher A Willner II, DO",{"facility":170,"status":60,"city":171,"state":172,"zip":173,"country":64,"countryCode":65,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Washington University - Siteman Cancer Center","St Louis","Missouri","63110",{"type":67,"coordinates":175},[176,177],-90.19789,38.62727,{"lat":177,"lon":176},[180],{"name":181,"role":75,"phone":50,"phoneExt":50,"email":50},"Geoffrey L Uy, MD",{"facility":183,"status":60,"city":184,"state":185,"zip":186,"country":64,"countryCode":65,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"John Theurer Cancer Center - Hackensack Meridian Health","Hackensack","New Jersey","07601",{"type":67,"coordinates":188},[189,190],-74.04347,40.88593,{"lat":190,"lon":189},[193],{"name":194,"role":75,"phone":50,"phoneExt":50,"email":50},"James K McCloskey, MD",{"facility":196,"status":60,"city":197,"state":185,"zip":198,"country":64,"countryCode":65,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Rutgers Cancer Institute","New Brunswick","08901",{"type":67,"coordinates":200},[201,202],-74.45182,40.48622,{"lat":202,"lon":201},[205],{"name":206,"role":75,"phone":50,"phoneExt":50,"email":50},"Neil D Palmisiano, MD, MS",{"facility":208,"status":60,"city":209,"state":210,"zip":211,"country":64,"countryCode":65,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Roswell Park Cancer Institute","Buffalo","New York","14203",{"type":67,"coordinates":213},[214,215],-78.87837,42.88645,{"lat":215,"lon":214},[218],{"name":219,"role":75,"phone":50,"phoneExt":50,"email":50},"Eunice S Wang, MD",{"facility":221,"status":60,"city":222,"state":210,"zip":223,"country":64,"countryCode":65,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"North Shore University Hospital","Manhasset","11030",{"type":67,"coordinates":225},[226,227],-73.69957,40.79788,{"lat":227,"lon":226},[230],{"name":231,"role":75,"phone":50,"phoneExt":50,"email":50},"David Chitty, MD",{"facility":233,"status":60,"city":210,"state":210,"zip":234,"country":64,"countryCode":65,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"NYU Langone Health","10016",{"type":67,"coordinates":236},[237,238],-74.00597,40.71427,{"lat":238,"lon":237},[241],{"name":242,"role":75,"phone":50,"phoneExt":50,"email":50},"Jun H Choi, MD",{"facility":244,"status":60,"city":210,"state":210,"zip":245,"country":64,"countryCode":65,"cosmosGeoPoint":246,"geoPoint":248,"contacts":249},"Columbia University Irving Medical Center","10032",{"type":67,"coordinates":247},[237,238],{"lat":238,"lon":237},[250],{"name":251,"role":75,"phone":50,"phoneExt":50,"email":50},"Sunil Iyer, MD",{"facility":253,"status":60,"city":254,"state":255,"zip":256,"country":64,"countryCode":65,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Novant Health Presbyterian Medical Center","Charlotte","North Carolina","28204",{"type":67,"coordinates":258},[259,260],-80.84313,35.22709,{"lat":260,"lon":259},[263],{"name":264,"role":75,"phone":50,"phoneExt":50,"email":50},"Abhishek Chilkulwar, MD",{"facility":266,"status":60,"city":267,"state":255,"zip":268,"country":64,"countryCode":65,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Novant Health Derrick L Davis Cancer Center","Winston-Salem","27103",{"type":67,"coordinates":270},[271,272],-80.24422,36.09986,{"lat":272,"lon":271},[275],{"name":264,"role":75,"phone":50,"phoneExt":50,"email":50},{"facility":277,"status":60,"city":278,"state":279,"zip":280,"country":64,"countryCode":65,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":67,"coordinates":282},[283,284],-81.69541,41.4995,{"lat":284,"lon":283},[287],{"name":288,"role":75,"phone":50,"phoneExt":50,"email":50},"Akriti Jain, MD",{"facility":290,"status":60,"city":291,"state":292,"zip":293,"country":64,"countryCode":65,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"Sydney Kimmel (Thomas Jefferson University)","Philadelphia","Pennsylvania","19107",{"type":67,"coordinates":295},[296,297],-75.16362,39.95238,{"lat":297,"lon":296},[300],{"name":301,"role":75,"phone":50,"phoneExt":50,"email":50},"Gina Keiffer, MD",{"facility":303,"status":60,"city":304,"state":305,"zip":306,"country":64,"countryCode":65,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"Sarah Cannon, the Cancer Institute of HCA Healthcare","Nashville","Tennessee","37203",{"type":67,"coordinates":308},[309,310],-86.78444,36.16589,{"lat":310,"lon":309},[313],{"name":314,"role":75,"phone":50,"phoneExt":50,"email":50},"Stephen A Strickland, MD",{"facility":316,"status":60,"city":304,"state":305,"zip":306,"country":64,"countryCode":65,"cosmosGeoPoint":317,"geoPoint":319,"contacts":320},"Tennessee Oncology",{"type":67,"coordinates":318},[309,310],{"lat":310,"lon":309},[321],{"name":322,"role":75,"phone":50,"phoneExt":50,"email":50},"Jonathan Abbas, MD",{"facility":324,"status":60,"city":325,"state":326,"zip":327,"country":64,"countryCode":65,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"Baylor Scott & White Health","Dallas","Texas","75246",{"type":67,"coordinates":329},[330,331],-96.80667,32.78306,{"lat":331,"lon":330},[334],{"name":335,"role":75,"phone":50,"phoneExt":50,"email":50},"Bradley W Christensen, MD",{"facility":337,"status":60,"city":338,"state":326,"zip":339,"country":64,"countryCode":65,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"University of Texas MD Anderson Cancer Center","Houston","77030",{"type":67,"coordinates":341},[342,343],-95.36327,29.76328,{"lat":343,"lon":342},[346],{"name":347,"role":75,"phone":50,"phoneExt":50,"email":50},"Naval G Daver, MD",{"facility":349,"status":60,"city":350,"state":351,"zip":352,"country":353,"countryCode":354,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"Concord Repatriation General Hospital","Concord","New South Wales","2139","Australia","AU",{"type":67,"coordinates":356},[357,358],151.10381,-33.84722,{"lat":358,"lon":357},[361],{"name":362,"role":75,"phone":50,"phoneExt":50,"email":50},"Robin Gasiorowski, MBBS",{"facility":364,"status":60,"city":365,"state":366,"zip":367,"country":353,"countryCode":354,"cosmosGeoPoint":368,"geoPoint":372,"contacts":373},"Townsville Hospital","Douglas","Queensland","4814",{"type":67,"coordinates":369},[370,371],146.75234,-19.32394,{"lat":371,"lon":370},[374],{"name":375,"role":75,"phone":50,"phoneExt":50,"email":50},"Rachael Boles, MD",{"facility":377,"status":60,"city":378,"state":379,"zip":380,"country":353,"countryCode":354,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":67,"coordinates":382},[383,384],138.59863,-34.92866,{"lat":384,"lon":383},[387],{"name":388,"role":75,"phone":50,"phoneExt":50,"email":50},"Devendra Hiwase, MBBS",{"facility":390,"status":60,"city":391,"state":392,"zip":393,"country":353,"countryCode":354,"cosmosGeoPoint":394,"geoPoint":398,"contacts":399},"Box Hill Hospital","Box Hill","Victoria","3128",{"type":67,"coordinates":395},[396,397],145.12545,-37.81887,{"lat":397,"lon":396},[400],{"name":401,"role":75,"phone":50,"phoneExt":50,"email":50},"Stephen Ting, MBBS",{"facility":403,"status":60,"city":404,"state":392,"zip":405,"country":353,"countryCode":354,"cosmosGeoPoint":406,"geoPoint":410,"contacts":411},"Monash Medical Centre","Clayton","3168",{"type":67,"coordinates":407},[408,409],145.11667,-37.91667,{"lat":409,"lon":408},[412],{"name":413,"role":75,"phone":50,"phoneExt":50,"email":50},"Ashvind Prabahran, MD",{"facility":415,"status":60,"city":416,"state":392,"zip":417,"country":353,"countryCode":354,"cosmosGeoPoint":418,"geoPoint":422,"contacts":423},"St. Vincents Hospital","Fitzroy","3065",{"type":67,"coordinates":419},[420,421],144.97833,-37.79839,{"lat":421,"lon":420},[424],{"name":425,"role":75,"phone":50,"phoneExt":50,"email":50},"Shuh Ying Tan, MBBS",{"facility":427,"status":60,"city":428,"state":392,"zip":429,"country":353,"countryCode":354,"cosmosGeoPoint":430,"geoPoint":434,"contacts":435},"Austin Hospital","Heidelberg","3084",{"type":67,"coordinates":431},[432,433],145.06667,-37.75,{"lat":433,"lon":432},[436],{"name":437,"role":75,"phone":50,"phoneExt":50,"email":50},"Chun Yew Fong, MBBS, PhD",{"facility":439,"status":60,"city":440,"state":441,"zip":442,"country":353,"countryCode":354,"cosmosGeoPoint":443,"geoPoint":447,"contacts":448},"Royal Perth Hospital","Perth","Western Australia","6000",{"type":67,"coordinates":444},[445,446],115.8614,-31.95224,{"lat":446,"lon":445},[449],{"name":450,"role":75,"phone":50,"phoneExt":50,"email":50},"Hun Chuah, MBBS, PhD",{"type":452,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100551159","phase-2-a-study-of-tagraxofusp-in-combination-with-venetoclax-and-azacitidine-in-adults-with-untreated-cd123-acute-myeloid-leukemia-who-cannot-undergo-intensive-chemotherapy-100551159",false,"NCT06456463","A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy","A Phase II Multicenter Open-label Trial of Tagraxofusp (Tag) in Combination With Venetoclax and Azacitidine (Ven\u002FAza) in Adults With Previously Untreated CD123+ Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy","TRILLIUM","Key Inclusion Criteria:\n\n* Previously untreated with histological confirmation of AML by World Health Organization 2022 criteria and are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity.\n* Participant has any level of CD123 expression on blasts.\n* Participants must be considered ineligible for intensive chemotherapy, defined by the following:\n\n  * ≥75 years of age; or\n  * ≥18 to 74 years of age with at least 1 of the following:\n\n    * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.\n    * Diffusing capacity of the lung for carbon monoxide of ≤65% or forced expiratory volume in 1 second ≤65%.\n    * Baseline creatinine clearance ≥30 to \\\u003C45 milliliters\u002Fminute calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.\n    * Hepatic disorder with total bilirubin \\>1.5 x upper limit of normal.\n    * Any other condition for which the physician judges the participant to be unsuitable for intensive chemotherapy.\n* ECOG performance status:\n\n  * 0 to 2 for participants ≥75 years of age, or\n  * 0 to 3 for participants ≥18 to 74 years of age.\n\nKey Exclusion Criteria:\n\n* Participant has received prior therapy for AML.\n* Participant is willing and able to receive standard induction therapy.\n* Participant has received treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, SCT, chimeric antigen receptor-T therapy, or other experimental therapies.\n* Participant has AML with central nervous system involvement.\n\nNote: Other inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":464,"type":465},83,"ESTIMATED","INTERVENTIONAL",[468],"PHASE2","This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp (9 and 12 micrograms\u002Fkilogram\u002Fday \\[μg\u002Fkg\u002Fday\\]), used in combination with venetoclax and azacitidine, to determine the dose for Part 2. This determined dose, in combination with venetoclax and azacitidine, will then be further evaluated in Part 2 in 2 cohorts (TP53 mutated and TP53 wild type). Both parts will be conducted in participants with previously untreated CD123+ AML who are ineligible for intensive chemotherapy.",[471],"Acute Myeloid Leukemia",[473,30,37,44],"CD123+","2026-03-05",{"date":476,"type":477},"2026-03-09","ACTUAL",{"date":479,"type":477},"2025-01-14",{"date":481,"type":465},"2030-02-11",{"name":5,"class":6},32]