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New hope for older leukemia patients: targeted combo shows promise

NCT ID NCT06456463

Disease control Sponsor: Stemline Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study is for adults with a specific type of acute myeloid leukemia (CD123+ AML) who cannot receive standard strong chemotherapy. It tests a new drug, tagraxofusp, added to two other drugs (venetoclax and azacitidine) to see if it helps more people achieve complete remission. The trial involves about 83 participants and will first find the best dose of tagraxofusp, then test that dose in two groups based on genetic markers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

85 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

Contacts and locations

Locations

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804, United States

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Baylor Scott & White Health

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Dana Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02114, United States

  • Henry Ford Health System Brigitte Harris Cancer Pavillion

    Detroit, Michigan, 48202, United States

  • John Theurer Cancer Center - Hackensack Meridian Health

    Hackensack, New Jersey, 07601, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • NYU Langone Health

    New York, New York, 10016, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Novant Health Derrick L Davis Cancer Center

    Winston-Salem, North Carolina, 27103, United States

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14203, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901, United States

  • Sarah Cannon, the Cancer Institute of HCA Healthcare

    Nashville, Tennessee, 37203, United States

  • St. Vincents Hospital

    Fitzroy, Victoria, 3065, Australia

  • Stanford Health Care

    Stanford, California, 94305, United States

  • Sydney Kimmel (Thomas Jefferson University)

    Philadelphia, Pennsylvania, 19107, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Townsville Hospital

    Douglas, Queensland, 4814, Australia

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Washington University - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.