Actively Recruiting
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
Led by Stemline Therapeutics, Inc. · Updated on 2026-03-09
83
Participants Needed
32
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with previously untreated acute myeloid leukemia (AML) confirmed by WHO 2022 criteria
- Participants must have any level of CD123 expression on leukemia blasts
- Ineligible for intensive chemotherapy due to age or health conditions
- Age 75 years or older, or age 18 to 74 with at least one of: ECOG performance status 2 or 3, lung function impairments, reduced kidney function, liver disorder, or other physician-judged unsuitability for intensive chemotherapy
- ECOG performance status 0 to 2 for participants 75 years or older, or 0 to 3 for participants aged 18 to 74
You will not qualify if you...
- Prior therapy for acute myeloid leukemia
- Willingness and ability to receive standard intensive chemotherapy
- Previous treatment for related blood diseases with hypomethylating agents, venetoclax, tagraxofusp, purine analogues, cytarabine, intensive chemotherapy, stem cell transplant, CAR-T therapy, or other experimental treatments
- Acute myeloid leukemia involving the central nervous system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Stanford Health Care
Stanford, California, United States, 94305
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
4
AdventHealth Cancer Institute
Orlando, Florida, United States, 32804
Actively Recruiting
5
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Henry Ford Health System Brigitte Harris Cancer Pavillion
Detroit, Michigan, United States, 48202
Actively Recruiting
10
Washington University - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
11
John Theurer Cancer Center - Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
Actively Recruiting
12
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
13
Roswell Park Cancer Institute
Buffalo, New York, United States, 14203
Actively Recruiting
14
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
15
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
16
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
17
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
18
Novant Health Derrick L Davis Cancer Center
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
19
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
Sydney Kimmel (Thomas Jefferson University)
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
21
Sarah Cannon, the Cancer Institute of HCA Healthcare
Nashville, Tennessee, United States, 37203
Actively Recruiting
22
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
23
Baylor Scott & White Health
Dallas, Texas, United States, 75246
Actively Recruiting
24
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
25
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Actively Recruiting
26
Townsville Hospital
Douglas, Queensland, Australia, 4814
Actively Recruiting
27
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
28
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
29
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
30
St. Vincents Hospital
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
31
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
32
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
Research Team
S
Stemline Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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