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A Study of Tagraxofusp, Venetoclax, and Azacitidine for Untreated CD123+ AML

This study is testing a combination of three drugs: Tagraxofusp, Venetoclax, and Azacitidine, for adults with a type of blood cancer called Acute Myeloid Leukemia (AML). You might be able to join if you have newly diagnosed AML with a specific marker called CD123 on your cancer cells, and you cannot receive standard intensive chemotherapy. The study will first determine the best dose of Tagraxofusp to use with the other two drugs. Then, it will look at how many participants achieve a complete remission (when signs of cancer disappear) within the first four cycles of treatment. The study is currently enrolling 83 participants, but its overall status is unclear.

Study design
This study is interventional and plans to enroll 83 participants. It is divided into two parts, first to find the right dose of Tagraxofusp, and then to evaluate its effectiveness in two groups based on a gene mutation (TP53).
What's involved
Tagraxofusp will be given by IV for 3 days each 28-day cycle. Venetoclax is an oral tablet taken daily, and Azacitidine is given by injection or IV for 7 days each 28-day cycle. The primary endpoints are measured over 4 cycles (up to 112 days).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured for up to 112 days (4 cycles of 28 days each).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06456463

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Stemline Therapeutics, Inc.
~85 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:TagraxofuspVenetoclaxAzacitidine

At a glance

Recruiting sites
0 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and Azacitidine
Measured over Cycles 1-4 (up to 112 days; 28 days/cycle)
+1 more outcome measured

Conditions

Acute Myeloid Leukemia

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Where it's being run

32 sites across 18 states
New York4
Victoria4
Massachusetts3
California2
Florida2
New Jersey2
North Carolina2
Tennessee2

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Part 1: Determination of Part 2 Selected Dose of Tagraxofusp When Administered in Combination with Venetoclax and AzacitidineCycles 1-4 (up to 112 days; 28 days/cycle)
  • Part 2: Number of Participants Achieving a Best Overall Response (BOR) of Complete Remission (CR)Cycles 1-4 (up to 112 days; 28 days/cycle)