Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Gary J. Schiller, MD (ucla)
Headshot of Gary J. Schiller
Gary J. Schiller

Description

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.

Official Title

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

Keywords

Acute Myeloid Leukemia, CD123+, Tagraxofusp, Venetoclax, Azacitidine, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Tagraxofusp (9 μg/kg/day), Tagraxofusp (12 μg/kg/day)

Eligibility

Locations

  • University of California, Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • Huntsman Cancer Institute not yet accepting patients
    Salt Lake City Utah 84132 United States
  • Baylor Scott & White Health accepting new patients
    Dallas Texas 75246 United States
  • University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Lead Scientist at University of California Health

  • Gary J. Schiller, MD (ucla)
    Professor-in-Residence, Medicine. Authored (or co-authored) 163 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Stemline Therapeutics, Inc.
ID
NCT06456463
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 76 study participants
Last Updated