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

Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Previously untreated with histological confirmation of AML by World Health Organization 2022 criteria and are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity.

• Participant has any level of CD123 expression on blasts.

• Participants must be considered ineligible for intensive chemotherapy, defined by the following:

‣ ≥75 years of age; or

⁃ ≥18 to 74 years of age with at least 1 of the following:

• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.

∙ Diffusing capacity of the lung for carbon monoxide of ≤65% or forced expiratory volume in 1 second ≤65%.

∙ Baseline creatinine clearance ≥30 to \<45 milliliters/minute calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.

∙ Hepatic disorder with total bilirubin \>1.5 x upper limit of normal.

∙ Any other condition for which the physician judges the participant to be unsuitable for intensive chemotherapy.

• ECOG performance status:

‣ 0 to 2 for participants ≥75 years of age, or

⁃ 0 to 3 for participants ≥18 to 74 years of age.

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Stanford University Medical Center
NOT_YET_RECRUITING
Palo Alto
Florida
University of Miami
RECRUITING
Miami
AdventHealth Cancer Institute
RECRUITING
Orlando
Illinois
University of Chicago
NOT_YET_RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana Farber Cancer Institute (DFCI)
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Henry Ford Health
NOT_YET_RECRUITING
Detroit
Missouri
Washington University - Siteman Cancer Center
RECRUITING
St Louis
North Carolina
Novant Health Presbyterian Medical Center
RECRUITING
Charlotte
Novant Health Derrick L Davis Cancer Center
RECRUITING
Winston-salem
New Jersey
John Theurer Cancer Center - Hackensack Meridian Health
RECRUITING
Hackensack
Rutgers Cancer Institute
RECRUITING
New Brunswick
New York
Roswell Park Comprehensive Cancer Center
NOT_YET_RECRUITING
Buffalo
North Shore University Hospital
NOT_YET_RECRUITING
Manhasset
Columbia University Irving Medical Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Sydney Kimmel (Thomas Jefferson University)
NOT_YET_RECRUITING
Philadelphia
Tennessee
Sarah Cannon, the Cancer Institute of HCA Healthcare
RECRUITING
Nashville
Tennessee Oncology
RECRUITING
Nashville
Texas
Baylor Scott & White Health
RECRUITING
Dallas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Utah
Huntsman Cancer Institute
NOT_YET_RECRUITING
Salt Lake City
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Box Hill Hospital
RECRUITING
Box Hill
Monash Medical Centre
RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
St. Vincents Hospital
RECRUITING
Fitzroy
Austin Hospital
RECRUITING
Heidelberg
Royal Perth Hospital
NOT_YET_RECRUITING
Perth
Townsville Hospital
NOT_YET_RECRUITING
Townsville
Contact Information
Primary
Stemline Trials
clinicaltrials@menarinistemline.com
1-877-332-7961
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2030-02-11
Participants
Target number of participants: 76
Treatments
Experimental: Part 1 - Tagraxofusp (9 μg/kg/day)
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
Experimental: Part 1 - Tagraxofusp (12 μg/kg/day)
Participants will receive tagraxofusp in combination with venetoclax and azacitidine.
Experimental: Part 2 - Tagraxofusp (Selected Dose) and TP53 Wild Type
Participants (TP53 wild type) will receive tagraxofusp in combination with venetoclax and azacitidine.
Experimental: Part 2 - Tagraxofusp (Selected Dose) and TP53 Mutated
Participants (TP53 mutated) will receive tagraxofusp in combination with venetoclax and azacitidine.
Related Therapeutic Areas
Sponsors
Leads: Stemline Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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