A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy (NCT06456463)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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 \[ฮผg/kg/day\]), 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.
Who can join: Review the eligibility criteria below.
Location: University of California, Los Angeles โ Los Angeles, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (32 Sites)
Showing the first 25 of 32 sites.
- University of California, Los Angeles โ Los Angeles, California
- Stanford Health Care โ Stanford, California
- University of Miami โ Miami, Florida
- AdventHealth Cancer Institute โ Orlando, Florida
- University of Chicago โ Chicago, Illinois
- Dana Farber Cancer Institute (DFCI) โ Boston, Massachusetts
- Massachusetts General Hospital โ Boston, Massachusetts
- Beth Israel Deaconess Medical Center โ Boston, Massachusetts
- Henry Ford Health System Brigitte Harris Cancer Pavillion โ Detroit, Michigan
- Washington University - Siteman Cancer Center โ St Louis, Missouri
- John Theurer Cancer Center - Hackensack Meridian Health โ Hackensack, New Jersey
- Rutgers Cancer Institute โ New Brunswick, New Jersey
- Roswell Park Cancer Institute โ Buffalo, New York
- North Shore University Hospital โ Manhasset, New York
- NYU Langone Health โ New York, New York
- Columbia University Irving Medical Center โ New York, New York
- Novant Health Presbyterian Medical Center โ Charlotte, North Carolina
- Novant Health Derrick L Davis Cancer Center โ Winston-Salem, North Carolina
- Cleveland Clinic Foundation โ Cleveland, Ohio
- Sydney Kimmel (Thomas Jefferson University) โ Philadelphia, Pennsylvania
- Sarah Cannon, the Cancer Institute of HCA Healthcare โ Nashville, Tennessee
- Tennessee Oncology โ Nashville, Tennessee
- Baylor Scott & White Health โ Dallas, Texas
- University of Texas MD Anderson Cancer Center โ Houston, Texas
- Concord Repatriation General Hospital โ Concord, New South Wales
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy โ Little Rock, Arkansas
- Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia โ Burbank, California
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Explore by condition: All Acute Myeloid Leukemia clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.