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A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
Sponsor: Stemline Therapeutics, Inc.
Summary
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.
Official title: A Phase II Multicenter Open-label Trial of Tagraxofusp (Tag) in Combination With Venetoclax and Azacitidine (Ven/Aza) in Adults With Previously Untreated CD123+ Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2025-01-14
Completion Date
2030-02-11
Last Updated
2026-03-09
Healthy Volunteers
No
Conditions
Interventions
Tagraxofusp
Tagraxofusp will be administered by intravenous infusion for 3 consecutive days during each 28-day cycle.
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.
Azacitidine
Azacitidine will be administered subcutaneously or by intravenous infusion (75 milligrams/square meter) over 7 days of each 28-day cycle, per institutional guidelines/physician choice.
Locations (32)
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
Townsville Hospital
Douglas, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St. Vincents Hospital
Fitzroy, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia