๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-04

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

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Stemline Therapeutics, Inc.

๐Ÿฉบ 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

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—