RecruitingPhase 1Phase 2NCT07148180

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax


Sponsor

Jacqueline Garcia, MD

Enrollment

31 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence. The names of the study drugs involved in this study are: * Tagraxofusp (a type of CD123-directed cytotoxin) * Azacitidine (a type of standard of care cytidine nucleoside analog) * Venetoclax (a type of standard of care BCL-2 inhibitor)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — tagraxofusp, azacitidine, and venetoclax — in adults with acute myeloid leukemia (AML) who are in remission but still have very small amounts of detectable cancer cells (called measurable residual disease, or MRD). **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of AML - You are in remission (complete or near-complete) with less than 5% cancer cells in your bone marrow - Your cancer cells test positive for a marker called CD123 - Residual disease is still detectable at 0.1% or more by specialized testing - Your heart, liver, and kidney function are adequate **You may NOT be eligible if...** - You are not in remission - You have significant organ dysfunction - Your cancer cells do not have the CD123 marker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTagraxofusp

A CD123-directed cytotoxin, Single-use vial, via intravenous (into the vein) infusion per protocol.

DRUGAzacitidine (AZA)

A cytidine nucleoside analog, single-use vial, via intravenous infusion or subcutaneous (under the skin) injection per standard of care.

DRUGVenetoclax

A BCL-2 inhibitor, tablet, via orally per standard of care.


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07148180


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