A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
Running, not enrolling · Phase 2
Conditions studied: Acute Myeloid Leukemia
In brief
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.
Key facts
- Study ID
- NCT06456463
- Run by
- Stemline Therapeutics, Inc.
- People needed
- 85
- Starts
- 2025-01-14
- Expected to finish
- 2030-02-11
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California, Los Angeles — Los Angeles, California, United States
- Stanford Health Care — Stanford, California, United States
- University of Miami — Miami, Florida, United States
- AdventHealth Cancer Institute — Orlando, Florida, United States
- University of Chicago — Chicago, Illinois, United States
- Dana Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Henry Ford Health System Brigitte Harris Cancer Pavillion — Detroit, Michigan, United States
- Washington University - Siteman Cancer Center — St Louis, Missouri, United States
- John Theurer Cancer Center - Hackensack Meridian Health — Hackensack, New Jersey, United States
- Rutgers Cancer Institute — New Brunswick, New Jersey, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- North Shore University Hospital — Manhasset, New York, United States
- NYU Langone Health — New York, New York, United States
- Columbia University Irving Medical Center — New York, New York, United States
- Novant Health Presbyterian Medical Center — Charlotte, North Carolina, United States
- Novant Health Derrick L Davis Cancer Center — Winston-Salem, North Carolina, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Sydney Kimmel (Thomas Jefferson University) — Philadelphia, Pennsylvania, United States
- Sarah Cannon, the Cancer Institute of HCA Healthcare — Nashville, Tennessee, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- Baylor Scott & White Health — Dallas, Texas, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Concord Repatriation General Hospital — Concord, New South Wales, Australia
Full record on ClinicalTrials.gov
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