A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
Start Date
1/14/2025
Completion Date
2/11/2030
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 Criteria
Age Range: 18 years to No maximum
Interventions
Tagraxofusp
Venetoclax
Azacitidine
Conditions
Locations
University of California, Los Angeles
Los Angeles, California 90095
United States
Stanford Health Care
Stanford, California 94305
United States
University of Miami
Miami, Florida 33136
United States
AdventHealth Cancer Institute
Orlando, Florida 32804
United States
University of Chicago
Chicago, Illinois 60637
United States
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts 02114
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Henry Ford Health System Brigitte Harris Cancer Pavillion
Detroit, Michigan 48202
United States
Washington University - Siteman Cancer Center
St Louis, Missouri 63110
United States
John Theurer Cancer Center - Hackensack Meridian Health
Hackensack, New Jersey 07601
United States
Rutgers Cancer Institute
New Brunswick, New Jersey 08901
United States
Roswell Park Cancer Institute
Buffalo, New York 14203
United States
North Shore University Hospital
Manhasset, New York 11030
United States
NYU Langone Health
New York, New York 10016
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina 28204
United States
Novant Health Derrick L Davis Cancer Center
Winston-Salem, North Carolina 27103
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Sydney Kimmel (Thomas Jefferson University)
Philadelphia, Pennsylvania 19107
United States
Sarah Cannon, the Cancer Institute of HCA Healthcare
Nashville, Tennessee 37203
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
Baylor Scott & White Health
Dallas, Texas 75246
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Concord Repatriation General Hospital
Concord, New South Wales 2139
Australia
Townsville Hospital
Douglas, Queensland 4814
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
Box Hill Hospital
Box Hill, Victoria 3128
Australia
Monash Medical Centre
Clayton, Victoria 3168
Australia
St. Vincents Hospital
Fitzroy, Victoria 3065
Australia
Austin Hospital
Heidelberg, Victoria 3084
Australia
Royal Perth Hospital
Perth, Western Australia 6000
Australia