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Study identifier: NCT06456463 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Condition: Acute Myeloid Leukemia  ·  Sponsor: Stemline Therapeutics, Inc.

PhasePhase 2
Planned participants83
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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/kilogram/day \[μg/kg/day\]), 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.

This description comes directly from the study's public registry record.

Talk to the study team

Stemline Trials  ·  1-877-332-7961  ·  clinicaltrials@menarinistemline.com

Always discuss trial participation with your own doctor first.

Locations (32)

University of California, Los AngelesLos Angeles, California, United StatesRecruiting
Stanford Health CareStanford, California, United StatesRecruiting
University of MiamiMiami, Florida, United StatesRecruiting
AdventHealth Cancer InstituteOrlando, Florida, United StatesRecruiting
University of ChicagoChicago, Illinois, United StatesRecruiting
Dana Farber Cancer Institute (DFCI)Boston, Massachusetts, United StatesRecruiting
Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting
Beth Israel Deaconess Medical CenterBoston, Massachusetts, United StatesRecruiting
Henry Ford Health System Brigitte Harris Cancer PavillionDetroit, Michigan, United StatesRecruiting
Washington University - Siteman Cancer CenterSt Louis, Missouri, United StatesRecruiting
John Theurer Cancer Center - Hackensack Meridian HealthHackensack, New Jersey, United StatesRecruiting
Rutgers Cancer InstituteNew Brunswick, New Jersey, United StatesRecruiting

+ 20 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06456463