[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551159":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":11,"studyPopulation":11,"armGroups":71,"interventions":91,"overallOfficials":11,"centralContacts":114,"locations":120,"responsibleParty":514,"collaborators":11,"id":516,"slug":11,"hasResults":517,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":517,"sex":523,"minAge":524,"maxAge":11,"enrollmentInfo":525,"targetDuration":11,"studyType":528,"phases":529,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":123,"whyStopped":11,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":545},{"fullName":5,"class":6},"Stemline Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine",null,"Cycles 1-4 (up to 112 days; 28 days\u002Fcycle)",{"measure":14,"description":11,"timeFrame":12},"Part 2: Number of Participants Achieving a Best Overall Response (BOR) of Complete Remission (CR)",[16,19,22,24,26,29,31,34,38,41,43,46,48,51,54,56,58,60,62],{"measure":17,"description":11,"timeFrame":18},"Parts 1 and 2: Number of Participants Achieving a BOR of CR","Cycles 1-6 (up to 168 days; 28 days\u002Fcycle)",{"measure":20,"description":21,"timeFrame":18},"Parts 1 and 2: Time to First CR","The time to first CR will be defined as the time from randomization (Cycle 1, Day 1) to the date of first documented CR.",{"measure":23,"description":11,"timeFrame":18},"Parts 1 and 2: Duration of Response",{"measure":25,"description":11,"timeFrame":12},"Parts 1 and 2: Number of Participants Achieving a BOR of CR, CR with Incomplete Hematologic Recovery (CRi), or CR with Partial Hematologic Recovery (CRh)",{"measure":27,"description":28,"timeFrame":12},"Parts 1 and 2: Time to First Composite CR","The time to first composite CR will be defined as the time from randomization (Cycle 1, Day 1) to the date of first documented CR, CRi, or CRh.",{"measure":30,"description":11,"timeFrame":18},"Parts 1 and 2: Number of Participants Achieving a BOR of CR or CRi",{"measure":32,"description":33,"timeFrame":18},"Parts 1 and 2: Time to first CR\u002FCRi","The time to first CR\u002FCRi will be defined as the time from randomization (Cycle 1, Day 1) to the date of first documented CR or CRi.",{"measure":35,"description":36,"timeFrame":37},"Parts 1 and 2: Event-free Survival (EFS)","EFS will be defined as the time from the date of randomization (Cycle 1, Day 1) until the date of treatment failure, hematologic relapse after CR\u002FCRi\u002FCRh, or death from any cause, whichever occurs first.","Up to approximately 6 years",{"measure":39,"description":40,"timeFrame":18},"Parts 1 and 2: CR with Minimal Residual Disease (MRD) Negative","Defined as the number of participants with a presence of marrow MRD of less than 0.01% at the time of CR.",{"measure":42,"description":11,"timeFrame":37},"Parts 1 and 2: Number of Participants Who Bridged to Stem Cell Transplant (SCT) Through Study Treatment",{"measure":44,"description":11,"timeFrame":45},"Part 1: Plasma Concentration of Free Tagraxofusp, Venetoclax, and Azacitidine","Predose, up to 8 hours post dose (Days 4, 5, 6, 7, 14; Cycles 1-4; 28 days\u002Fcycle)",{"measure":47,"description":11,"timeFrame":45},"Part 2: Plasma Concentration of Free Tagraxofusp and Venetoclax",{"measure":49,"description":11,"timeFrame":50},"Parts 1 and 2: Number of Participants With Serum Anti-drug Antibodies for Tagraxofusp, Venetoclax, and Azacitidine","Day 4 of each cycle (each cycle is 28 days) up to the end of study (approximately 6 years)",{"measure":52,"description":53,"timeFrame":37},"Parts 1 and 2: Exposure-response of Free Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine","The exposure-response relationship will be assessed utilizing the CR rate\u002Fcomposite CR rate and the number of participants experiencing adverse events of interest. This model-based analysis will be conducted to compare the exposure and response of free tagraxofusp, venetoclax, and azacitidine with venetoclax and azacitidine. Results will be reported as percent probability, wherein changes in the percent probability would indicate corresponding changes in the response rates with changes in exposure.",{"measure":55,"description":11,"timeFrame":37},"Parts 1 and 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)",{"measure":57,"description":11,"timeFrame":37},"Parts 1 and 2: Overall Survival",{"measure":59,"description":11,"timeFrame":45},"Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Tagraxofusp and Venetoclax",{"measure":61,"description":11,"timeFrame":45},"Parts 1 and 2: Time to Reach Cmax (Tmax) of Tagraxofusp and Venetoclax",{"measure":63,"description":11,"timeFrame":45},"Parts 1 and 2: Area Under the Concentration-time Curve (AUC) of Tagraxofusp and Venetoclax",{"allocation":65,"interventionModel":66,"interventionModelDescription":67,"primaryPurpose":68,"observationalModel":11,"timePerspective":11,"maskingInfo":69},"RANDOMIZED","SEQUENTIAL","Part 1 (randomized) will evaluate 2 dose levels of tagraxofusp in parallel. The decision to proceed to Part 2 (non-randomized) will be based upon review of cumulative data from Part 1.","TREATMENT",{"masking":70,"maskingDescription":11,"whoMasked":11},"NONE",[72,80,83,87],{"label":73,"type":74,"description":75,"interventionNames":76},"Part 1 - Tagraxofusp (9 μg\u002Fkg\u002Fday)","EXPERIMENTAL","Participants will receive tagraxofusp in combination with venetoclax and azacitidine.",[77,78,79],"Drug: Tagraxofusp","Drug: Venetoclax","Drug: Azacitidine",{"label":81,"type":74,"description":75,"interventionNames":82},"Part 1 - Tagraxofusp (12 μg\u002Fkg\u002Fday)",[77,78,79],{"label":84,"type":74,"description":85,"interventionNames":86},"Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type","Participants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine.",[77,78,79],{"label":88,"type":74,"description":89,"interventionNames":90},"Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated","Participants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine.",[77,78,79],[92,100,107],{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"DRUG","Tagraxofusp","Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.",[81,73,88,84],[98,99],"Tag","Elzonris",{"type":93,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"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.",[81,73,88,84],[105,106],"Ven","Venclexta",{"type":93,"name":108,"description":109,"armGroupLabels":110,"otherNames":111},"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.",[81,73,88,84],[112,113],"Aza","Vidaza",[115],{"name":116,"role":117,"phone":118,"phoneExt":11,"email":119},"Stemline Trials","CONTACT","1-877-332-7961","clinicaltrials@menarinistemline.com",[121,139,151,164,176,189,202,210,219,232,245,258,270,283,295,306,315,328,339,352,365,378,386,399,411,426,439,452,465,477,489,501],{"facility":122,"status":123,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":134,"contacts":135},"University of California, Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":130,"coordinates":131},"Point",[132,133],-118.24368,34.05223,{"lat":133,"lon":132},[136],{"name":137,"role":138,"phone":11,"phoneExt":11,"email":11},"Gary Schiller, MD","PRINCIPAL_INVESTIGATOR",{"facility":140,"status":123,"city":141,"state":125,"zip":142,"country":127,"countryCode":128,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Stanford Health Care","Stanford","94305",{"type":130,"coordinates":144},[145,146],-122.16608,37.42411,{"lat":146,"lon":145},[149],{"name":150,"role":138,"phone":11,"phoneExt":11,"email":11},"Gabriel Mannis, MD",{"facility":152,"status":123,"city":153,"state":154,"zip":155,"country":127,"countryCode":128,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"University of Miami","Miami","Florida","33136",{"type":130,"coordinates":157},[158,159],-80.19366,25.77427,{"lat":159,"lon":158},[162],{"name":163,"role":138,"phone":11,"phoneExt":11,"email":11},"Namrata Chandhok, MD",{"facility":165,"status":123,"city":166,"state":154,"zip":167,"country":127,"countryCode":128,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"AdventHealth Cancer Institute","Orlando","32804",{"type":130,"coordinates":169},[170,171],-81.37924,28.53834,{"lat":171,"lon":170},[174],{"name":175,"role":138,"phone":11,"phoneExt":11,"email":11},"Shahram Mori, MD, PhD",{"facility":177,"status":123,"city":178,"state":179,"zip":180,"country":127,"countryCode":128,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"University of Chicago","Chicago","Illinois","60637",{"type":130,"coordinates":182},[183,184],-87.65005,41.85003,{"lat":184,"lon":183},[187],{"name":188,"role":138,"phone":11,"phoneExt":11,"email":11},"Anand Patel, MD",{"facility":190,"status":123,"city":191,"state":192,"zip":193,"country":127,"countryCode":128,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Dana Farber Cancer Institute (DFCI)","Boston","Massachusetts","02114",{"type":130,"coordinates":195},[196,197],-71.05977,42.35843,{"lat":197,"lon":196},[200],{"name":201,"role":138,"phone":11,"phoneExt":11,"email":11},"Andrew A Lane, MD, PhD",{"facility":203,"status":123,"city":191,"state":192,"zip":193,"country":127,"countryCode":128,"cosmosGeoPoint":204,"geoPoint":206,"contacts":207},"Massachusetts General Hospital",{"type":130,"coordinates":205},[196,197],{"lat":197,"lon":196},[208],{"name":209,"role":138,"phone":11,"phoneExt":11,"email":11},"Amir Fathi, MD",{"facility":211,"status":123,"city":191,"state":192,"zip":212,"country":127,"countryCode":128,"cosmosGeoPoint":213,"geoPoint":215,"contacts":216},"Beth Israel Deaconess Medical Center","02215",{"type":130,"coordinates":214},[196,197],{"lat":197,"lon":196},[217],{"name":218,"role":138,"phone":11,"phoneExt":11,"email":11},"Malgorzata McMasters, MD",{"facility":220,"status":123,"city":221,"state":222,"zip":223,"country":127,"countryCode":128,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Henry Ford Health System Brigitte Harris Cancer Pavillion","Detroit","Michigan","48202",{"type":130,"coordinates":225},[226,227],-83.04575,42.33143,{"lat":227,"lon":226},[230],{"name":231,"role":138,"phone":11,"phoneExt":11,"email":11},"Christopher A Willner II, DO",{"facility":233,"status":123,"city":234,"state":235,"zip":236,"country":127,"countryCode":128,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Washington University - Siteman Cancer Center","St Louis","Missouri","63110",{"type":130,"coordinates":238},[239,240],-90.19789,38.62727,{"lat":240,"lon":239},[243],{"name":244,"role":138,"phone":11,"phoneExt":11,"email":11},"Geoffrey L Uy, MD",{"facility":246,"status":123,"city":247,"state":248,"zip":249,"country":127,"countryCode":128,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"John Theurer Cancer Center - Hackensack Meridian Health","Hackensack","New Jersey","07601",{"type":130,"coordinates":251},[252,253],-74.04347,40.88593,{"lat":253,"lon":252},[256],{"name":257,"role":138,"phone":11,"phoneExt":11,"email":11},"James K McCloskey, MD",{"facility":259,"status":123,"city":260,"state":248,"zip":261,"country":127,"countryCode":128,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Rutgers Cancer Institute","New Brunswick","08901",{"type":130,"coordinates":263},[264,265],-74.45182,40.48622,{"lat":265,"lon":264},[268],{"name":269,"role":138,"phone":11,"phoneExt":11,"email":11},"Neil D Palmisiano, MD, MS",{"facility":271,"status":123,"city":272,"state":273,"zip":274,"country":127,"countryCode":128,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Roswell Park Cancer Institute","Buffalo","New York","14203",{"type":130,"coordinates":276},[277,278],-78.87837,42.88645,{"lat":278,"lon":277},[281],{"name":282,"role":138,"phone":11,"phoneExt":11,"email":11},"Eunice S Wang, MD",{"facility":284,"status":123,"city":285,"state":273,"zip":286,"country":127,"countryCode":128,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"North Shore University Hospital","Manhasset","11030",{"type":130,"coordinates":288},[289,290],-73.69957,40.79788,{"lat":290,"lon":289},[293],{"name":294,"role":138,"phone":11,"phoneExt":11,"email":11},"David Chitty, MD",{"facility":296,"status":123,"city":273,"state":273,"zip":297,"country":127,"countryCode":128,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"NYU Langone Health","10016",{"type":130,"coordinates":299},[300,301],-74.00597,40.71427,{"lat":301,"lon":300},[304],{"name":305,"role":138,"phone":11,"phoneExt":11,"email":11},"Jun H Choi, MD",{"facility":307,"status":123,"city":273,"state":273,"zip":308,"country":127,"countryCode":128,"cosmosGeoPoint":309,"geoPoint":311,"contacts":312},"Columbia University Irving Medical Center","10032",{"type":130,"coordinates":310},[300,301],{"lat":301,"lon":300},[313],{"name":314,"role":138,"phone":11,"phoneExt":11,"email":11},"Sunil Iyer, MD",{"facility":316,"status":123,"city":317,"state":318,"zip":319,"country":127,"countryCode":128,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Novant Health Presbyterian Medical Center","Charlotte","North Carolina","28204",{"type":130,"coordinates":321},[322,323],-80.84313,35.22709,{"lat":323,"lon":322},[326],{"name":327,"role":138,"phone":11,"phoneExt":11,"email":11},"Abhishek Chilkulwar, MD",{"facility":329,"status":123,"city":330,"state":318,"zip":331,"country":127,"countryCode":128,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Novant Health Derrick L Davis Cancer Center","Winston-Salem","27103",{"type":130,"coordinates":333},[334,335],-80.24422,36.09986,{"lat":335,"lon":334},[338],{"name":327,"role":138,"phone":11,"phoneExt":11,"email":11},{"facility":340,"status":123,"city":341,"state":342,"zip":343,"country":127,"countryCode":128,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":130,"coordinates":345},[346,347],-81.69541,41.4995,{"lat":347,"lon":346},[350],{"name":351,"role":138,"phone":11,"phoneExt":11,"email":11},"Akriti Jain, MD",{"facility":353,"status":123,"city":354,"state":355,"zip":356,"country":127,"countryCode":128,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Sydney Kimmel (Thomas Jefferson University)","Philadelphia","Pennsylvania","19107",{"type":130,"coordinates":358},[359,360],-75.16362,39.95238,{"lat":360,"lon":359},[363],{"name":364,"role":138,"phone":11,"phoneExt":11,"email":11},"Gina Keiffer, MD",{"facility":366,"status":123,"city":367,"state":368,"zip":369,"country":127,"countryCode":128,"cosmosGeoPoint":370,"geoPoint":374,"contacts":375},"Sarah Cannon, the Cancer Institute of HCA Healthcare","Nashville","Tennessee","37203",{"type":130,"coordinates":371},[372,373],-86.78444,36.16589,{"lat":373,"lon":372},[376],{"name":377,"role":138,"phone":11,"phoneExt":11,"email":11},"Stephen A Strickland, MD",{"facility":379,"status":123,"city":367,"state":368,"zip":369,"country":127,"countryCode":128,"cosmosGeoPoint":380,"geoPoint":382,"contacts":383},"Tennessee Oncology",{"type":130,"coordinates":381},[372,373],{"lat":373,"lon":372},[384],{"name":385,"role":138,"phone":11,"phoneExt":11,"email":11},"Jonathan Abbas, MD",{"facility":387,"status":123,"city":388,"state":389,"zip":390,"country":127,"countryCode":128,"cosmosGeoPoint":391,"geoPoint":395,"contacts":396},"Baylor Scott & White Health","Dallas","Texas","75246",{"type":130,"coordinates":392},[393,394],-96.80667,32.78306,{"lat":394,"lon":393},[397],{"name":398,"role":138,"phone":11,"phoneExt":11,"email":11},"Bradley W Christensen, MD",{"facility":400,"status":123,"city":401,"state":389,"zip":402,"country":127,"countryCode":128,"cosmosGeoPoint":403,"geoPoint":407,"contacts":408},"University of Texas MD Anderson Cancer Center","Houston","77030",{"type":130,"coordinates":404},[405,406],-95.36327,29.76328,{"lat":406,"lon":405},[409],{"name":410,"role":138,"phone":11,"phoneExt":11,"email":11},"Naval G Daver, MD",{"facility":412,"status":123,"city":413,"state":414,"zip":415,"country":416,"countryCode":417,"cosmosGeoPoint":418,"geoPoint":422,"contacts":423},"Concord Repatriation General Hospital","Concord","New South Wales","2139","Australia","AU",{"type":130,"coordinates":419},[420,421],151.10381,-33.84722,{"lat":421,"lon":420},[424],{"name":425,"role":138,"phone":11,"phoneExt":11,"email":11},"Robin Gasiorowski, MBBS",{"facility":427,"status":123,"city":428,"state":429,"zip":430,"country":416,"countryCode":417,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"Townsville Hospital","Douglas","Queensland","4814",{"type":130,"coordinates":432},[433,434],146.75234,-19.32394,{"lat":434,"lon":433},[437],{"name":438,"role":138,"phone":11,"phoneExt":11,"email":11},"Rachael Boles, MD",{"facility":440,"status":123,"city":441,"state":442,"zip":443,"country":416,"countryCode":417,"cosmosGeoPoint":444,"geoPoint":448,"contacts":449},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":130,"coordinates":445},[446,447],138.59863,-34.92866,{"lat":447,"lon":446},[450],{"name":451,"role":138,"phone":11,"phoneExt":11,"email":11},"Devendra Hiwase, MBBS",{"facility":453,"status":123,"city":454,"state":455,"zip":456,"country":416,"countryCode":417,"cosmosGeoPoint":457,"geoPoint":461,"contacts":462},"Box Hill Hospital","Box Hill","Victoria","3128",{"type":130,"coordinates":458},[459,460],145.12545,-37.81887,{"lat":460,"lon":459},[463],{"name":464,"role":138,"phone":11,"phoneExt":11,"email":11},"Stephen Ting, MBBS",{"facility":466,"status":123,"city":467,"state":455,"zip":468,"country":416,"countryCode":417,"cosmosGeoPoint":469,"geoPoint":473,"contacts":474},"Monash Medical Centre","Clayton","3168",{"type":130,"coordinates":470},[471,472],145.11667,-37.91667,{"lat":472,"lon":471},[475],{"name":476,"role":138,"phone":11,"phoneExt":11,"email":11},"Ashvind Prabahran, MD",{"facility":478,"status":123,"city":479,"state":455,"zip":480,"country":416,"countryCode":417,"cosmosGeoPoint":481,"geoPoint":485,"contacts":486},"St. Vincents Hospital","Fitzroy","3065",{"type":130,"coordinates":482},[483,484],144.97833,-37.79839,{"lat":484,"lon":483},[487],{"name":488,"role":138,"phone":11,"phoneExt":11,"email":11},"Shuh Ying Tan, MBBS",{"facility":490,"status":123,"city":491,"state":455,"zip":492,"country":416,"countryCode":417,"cosmosGeoPoint":493,"geoPoint":497,"contacts":498},"Austin Hospital","Heidelberg","3084",{"type":130,"coordinates":494},[495,496],145.06667,-37.75,{"lat":496,"lon":495},[499],{"name":500,"role":138,"phone":11,"phoneExt":11,"email":11},"Chun Yew Fong, MBBS, PhD",{"facility":502,"status":123,"city":503,"state":504,"zip":505,"country":416,"countryCode":417,"cosmosGeoPoint":506,"geoPoint":510,"contacts":511},"Royal Perth Hospital","Perth","Western Australia","6000",{"type":130,"coordinates":507},[508,509],115.8614,-31.95224,{"lat":509,"lon":508},[512],{"name":513,"role":138,"phone":11,"phoneExt":11,"email":11},"Hun Chuah, MBBS, PhD",{"type":515,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":526,"type":527},83,"ESTIMATED","INTERVENTIONAL",[530],"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.",[533],"Acute Myeloid Leukemia",[535,94,101,108],"CD123+","2026-03-05",{"date":538,"type":539},"2026-03-09","ACTUAL",{"date":541,"type":539},"2025-01-14",{"date":543,"type":527},"2030-02-11",{"name":5,"class":6},32]