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RecruitingLast updated: 27 November 2025

TRILLIUM: A study recruiting people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy to evaluate a combination of targeted therapies and chemotherapyA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

TRILLIUM

Clinical summary

Summary

This study will be divided into 2 parts (Part 1 and Part 2). Both parts will enrol participants with previously untreated CD123+ acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

Part 1 will evaluate two dose levels of tagraxofusp targeted therapy, used in combination with venetoclax targeted therapy and azacitidine chemotherapy, to determine the recommended dose for Part 2.

This determined dose of tagraxofusp, in combination with venetoclax and azacitidine, will then be further evaluated in Part 2 in two cohorts of participants (those with TP53 mutation and TP53 wild type).

Tagraxofusp will be administered by an intravenous (IV) infusion for 3 consecutive days during each 28-day cycle. Venetoclax will be given as an oral tablet daily of each 28-day cycle. Azacitidine will be administered either as an injection under the skin (subcutaneously) or by IV infusion over 7 days of each 28-day cycle, per institutional guidelines/physician choice.

Conditions

This trial is treating people with acute myeloid leukaemia that is CD123+ and who are ineligible for intensive chemotherapy

Eligibility

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 confirmed centrally by flow cytometry.

  • 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 comorbidities:

      • 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 comorbidity that the investigator judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor.

  • 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.
  • Willing and able to receive standard induction therapy.
  • Treatment for an antecedent hematologic disease with 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Stemline Therapeutics, Inc.

Scientific 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

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