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Combining Tagraxofusp, Venetoclax, and Azacitidine for Untreated Acute Myeloid Leukemia

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

PHASE2 · Stemline Therapeutics, Inc. · NCT06456463

This study is testing a new combination of three drugs to see if it can help adults with untreated acute myeloid leukemia who can't have intensive chemotherapy.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment83 (estimated)
Ages18 Years and up
SexAll
SponsorStemline Therapeutics, Inc. (industry)
Drugs / interventionschimeric antigen receptor, chemotherapy
Locations32 sites (Los Angeles, California and 31 other locations)
Trial IDNCT06456463 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of tagraxofusp in combination with venetoclax and azacitidine in adults with untreated CD123+ acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. The study is divided into two parts: the first part assesses two different doses of tagraxofusp to determine the optimal dose for the second part, which focuses on two cohorts based on TP53 mutation status. Participants must have histologically confirmed AML and meet specific criteria related to age and comorbidities to qualify for the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with untreated CD123+ AML who are ineligible for intensive chemotherapy due to age or comorbidities.

Not a fit: Patients with previously treated AML or those who are eligible for intensive chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with untreated CD123+ AML who cannot tolerate standard chemotherapy.

How similar studies have performed: While this approach is novel in combining these specific agents for this patient population, similar studies have shown promise in targeting CD123+ AML.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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.
* ECOG performance status:

  * 0 to 2 for participants ≥75 years of age, or
  * 0 to 3 for participants ≥18 to 74 years of age.

Key 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.

Note: Other inclusion/exclusion criteria may apply.

Where this trial is running

Los Angeles, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Myeloid Leukemia, CD123+, Tagraxofusp, Venetoclax, Azacitidine

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.