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.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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