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A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

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

NCT06456463•Stemline Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+3 more criteria

Exclusion Criteria

•Participant has received prior therapy for AML.
•Participant is willing and able to receive standard induction therapy.
•Participant has received treatment for an antecedent hematologic disease with a hypomethylating agent, venetoclax, tagraxofusp, purine analogue, cytarabine, intensive chemotherapy, SCT, chimeric antigen receptor-T therapy, or other experimental therapies.
•Participant has AML with central nervous system involvement.

Locations (32)

University of California, Los Angeles

Los Angeles, California, United States

Stanford Health Care

Stanford, California, United States

University of Miami

Miami, Florida, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

University of Chicago

Chicago, Illinois, United States

Dana Farber Cancer Institute (DFCI)

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Health System Brigitte Harris Cancer Pavillion

Detroit, Michigan, United States

Washington University - Siteman Cancer Center

St Louis, Missouri, United States

Key Dates

Start Date

January 14, 2025

Primary Completion Date

February 9, 2028

Completion Date

February 11, 2030

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia

Interventions

Tagraxofusp

DRUG

Venetoclax

DRUG

Azacitidine

DRUG

Contacts

Stemline Trials

CONTACT

1-877-332-7961 clinicaltrials@menarinistemline.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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