A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
NCT ID: NCT06456463
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
83 participants
INTERVENTIONAL
2025-01-14
2030-02-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 - Tagraxofusp (9 μg/kg/day)
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
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.
Part 1 - Tagraxofusp (12 μg/kg/day)
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
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.
Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type
Participants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine.
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.
Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated
Participants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has any level of CD123 expression on blasts.
* Participants must be considered ineligible for intensive chemotherapy, defined by the following:
* ≥75 years of age; or
* ≥18 to 74 years of age with at least 1 of the following:
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
* Diffusing capacity of the lung for carbon monoxide of ≤65% or forced expiratory volume in 1 second ≤65%.
* Baseline creatinine clearance ≥30 to \<45 milliliters/minute calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
* Hepatic disorder with total bilirubin \>1.5 x upper limit of normal.
* Any other condition for which the physician judges the participant to be unsuitable for intensive chemotherapy.
* ECOG performance status:
* 0 to 2 for participants ≥75 years of age, or
* 0 to 3 for participants ≥18 to 74 years of age.
Exclusion Criteria
* Participant is willing and able to receive standard induction therapy.
* 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.
* Participant has AML with central nervous system involvement.
18 Years
ALL
No
Sponsors
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Stemline Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Huntsman Cancer Institute
Salt Lake City, Utah, 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
Countries
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Central Contacts
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Other Identifiers
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U1111-1290-9087
Identifier Type: OTHER
Identifier Source: secondary_id
2024-514660-48
Identifier Type: OTHER
Identifier Source: secondary_id
STML-401-0423
Identifier Type: -
Identifier Source: org_study_id
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