🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Australia / NCT06456463
Active, not recruiting Phase 2

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

NCT06456463 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2025-01-14
Last updated
2026-08-06

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Tagraxofusp →Venetoclax →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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
University of California, Los Angeles Los Angeles California
Stanford Health Care Stanford California
University of Miami Miami Florida
AdventHealth Cancer Institute Orlando Florida
University of Chicago Chicago Illinois
Dana Farber Cancer Institute (DFCI) Boston Massachusetts
Massachusetts General Hospital Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
Henry Ford Health System Brigitte Harris Cancer Pavillion Detroit Michigan
Washington University - Siteman Cancer Center St Louis Missouri
John Theurer Cancer Center - Hackensack Meridian Health Hackensack New Jersey
Rutgers Cancer Institute New Brunswick New Jersey
Roswell Park Cancer Institute Buffalo New York
North Shore University Hospital Manhasset New York
NYU Langone Health New York New York
Columbia University Irving Medical Center New York New York
Novant Health Presbyterian Medical Center Charlotte North Carolina
Novant Health Derrick L Davis Cancer Center Winston-Salem North Carolina
Cleveland Clinic Foundation Cleveland Ohio
Sydney Kimmel (Thomas Jefferson University) Philadelphia Pennsylvania
Sarah Cannon, the Cancer Institute of HCA Healthcare Nashville Tennessee
Tennessee Oncology Nashville Tennessee
Baylor Scott & White Health Dallas Texas
University of Texas MD Anderson Cancer Center Houston Texas
Concord Repatriation General Hospital Concord New South Wales
Townsville Hospital Douglas Queensland
Royal Adelaide Hospital Adelaide South Australia
Box Hill Hospital Box Hill Victoria
Monash Medical Centre Clayton Victoria
St. Vincents Hospital Fitzroy Victoria
Austin Hospital Heidelberg Victoria
Royal Perth Hospital Perth Western Australia

On this site

📄 Venclexta (venetoclax) drug profile →

More Stemline Therapeutics, Inc. trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06456463 on ClinicalTrials.gov ↗ ← All trials in Australia