Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Gary Schiller, MD (ucla)

Description

Summary

This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp, 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. 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

Eligibility

You can join if…

Open to people ages 60 years and up

  • Histologically confirmed newly diagnosed AML with bone marrow blast count ≥20%.
  • Participant has any level of CD123 expression on blasts determined centrally by flow cytometry.
  • For participants between 60 and 74 years of age, 1 of the following comorbidities is required:
    • Eastern Cooperative Oncology Group (ECOG) Score of 2 or 3.
    • Diffusing capacity of lung for carbon monoxide of ≤65% or forced expiratory volume of 1 second ≤65%.
    • Creatinine clearance ≥30 to <45 milliliters/minute.
    • Moderate hepatic impairment with total bilirubin >1.5 to ≤3.0 x upper limit of normal.
    • Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor and Medical Monitor prior to enrollment.
  • ECOG performance status:
    • If ≥75 years of age, ECOG 0 to 2
    • If ≥60 to 74 years of age, ECOG 0 to 3

You CAN'T join if...

  • Participant has received prior therapy for AML.
  • Willing and able to receive standard induction therapy.
  • Treatment for an antecedent hematologic disease with any of the following:
    • A hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy.
    • Chimeric antigen receptor-T therapy or other experimental therapies.
  • AML with central nervous system involvement.

Note: Other inclusion/exclusion criteria may apply.

Locations

  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • Hunstman Cancer Institute
    Salt Lake City Utah 84132 United States

Lead Scientist at University of California Health

  • Gary Schiller, MD (ucla)
    Professor-in-Residence, Medicine. Authored (or co-authored) 155 research publications

Details

Status
not yet accepting patients
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