RecruitingRecruiting
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
NCT06456463 · Stemline Therapeutics, Inc.
In plain English
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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
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.
Eligibility criteria
Key Inclusion Criteria:
* Previously untreated with histological confirmation of AML by World Health Organization 2022 criteria and are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity.
* 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.
Key Exclusion Criteria:
* Participant has received prior therapy for AML.
* 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.
Note: Other inclusion/exclusion criteria may apply.
Study design
Enrollment target: 83 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-14
Estimated completion: 2030-02-11
Last updated: 2026-03-09
Interventions
Drug: TagraxofuspDrug: VenetoclaxDrug: Azacitidine
Primary outcomes
- • Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine (Cycles 1-4 (up to 112 days; 28 days/cycle))
- • Part 2: Number of Participants Achieving a Best Overall Response (BOR) of Complete Remission (CR) (Cycles 1-4 (up to 112 days; 28 days/cycle))
Sponsor
Stemline Therapeutics, Inc. · industry
Contacts & investigators
ContactStemline Trials · contact · clinicaltrials@menarinistemline.com · 1-877-332-7961
All locations (32)
University of California, Los AngelesRecruiting
Los Angeles, California, United States
Stanford Health CareRecruiting
Stanford, California, United States
University of MiamiRecruiting
Miami, Florida, United States
AdventHealth Cancer InstituteRecruiting
Orlando, Florida, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Dana Farber Cancer Institute (DFCI)Recruiting
Boston, Massachusetts, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Henry Ford Health System Brigitte Harris Cancer PavillionRecruiting
Detroit, Michigan, United States
Washington University - Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
John Theurer Cancer Center - Hackensack Meridian HealthRecruiting
Hackensack, New Jersey, United States
Rutgers Cancer InstituteRecruiting
New Brunswick, New Jersey, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
North Shore University HospitalRecruiting
Manhasset, New York, United States
NYU Langone HealthRecruiting
New York, New York, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
Novant Health Presbyterian Medical CenterRecruiting
Charlotte, North Carolina, United States
Novant Health Derrick L Davis Cancer CenterRecruiting
Winston-Salem, North Carolina, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Sydney Kimmel (Thomas Jefferson University)Recruiting
Philadelphia, Pennsylvania, United States
Sarah Cannon, the Cancer Institute of HCA HealthcareRecruiting
Nashville, Tennessee, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
Baylor Scott & White HealthRecruiting
Dallas, Texas, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Concord Repatriation General HospitalRecruiting
Concord, New South Wales, Australia
Townsville HospitalRecruiting
Douglas, Queensland, Australia
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Box Hill HospitalRecruiting
Box Hill, Victoria, Australia
Monash Medical CentreRecruiting
Clayton, Victoria, Australia
St. Vincents HospitalRecruiting
Fitzroy, Victoria, Australia
Austin HospitalRecruiting
Heidelberg, Victoria, Australia
Royal Perth HospitalRecruiting
Perth, Western Australia, Australia