What is this study trying to find out about Acute Myeloid Leukemia (AML)?

This study is evaluating a new combination of three drugs—azacitidine, venetoclax, and tagraxofusp—to see if it can safely control leftover leukemia cells and prevent AML from returning. The research is led by Dr. Jacqueline Garcia and aims to improve treatment options for patients with residual AML after initial therapy.

Who may be eligible for this Acute Myeloid Leukemia clinical trial?

Adults aged 18 years or older with a diagnosis of AML and less than 5% leukemia cells in their bone marrow may be eligible. Participants need to have a good overall health status and no prior treatment with CD123-targeted therapies. Please review eligibility criteria for more details.

Is there any cost to participate in this Acute Myeloid Leukemia clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID07148180

Testing a New Combination of Tagraxofusp, Azacitidine, and Venetoclax to Control Residual Acute Myeloid Leukemia and Prevent Relapse in Adults A Phase 12 Study

Led by Jacqueline Garcia, MD · Updated on 2026-02-05

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating a new combination of three drugsazacitidine, venetoclax, and tagraxofuspto treat patients with Acute Myeloid Leukemia AML who have leftover leukemia cells that cannot be seen with the naked eye. This Phase 12 clinical trial aims to assess the safety and how well this drug combination controls residual AML and prevents the disease from coming back. The study builds on FDA approvals of venetoclax and azacitidine together for AML and tagraxofusp alone for another leukemia type, but this combination is not yet FDA-approved for AML treatment. The study involves two groups of participants. In Phase 1, up to 12 people receive escalating doses of tagraxofusp combined with fixed doses of azacitidine and venetoclax to find the safest and best dose. Treatment cycles last 28 days, with azacitidine given daily for seven days, tagraxofusp infused on days 4 to 6, and venetoclax taken on days 1 and 14. In Phase 2, 19 participants receive the recommended dose of tagraxofusp plus azacitidine and venetoclax with the same schedule. Bone marrow biopsies and aspirations occur regularly during treatment to monitor response. After treatment, participants are followed for up to two years. Participants will have regular visits including blood tests, imaging scans like CT, MRI, or PET, heart function tests, and bone marrow examinations. Researchers will monitor for side effects, measure disease remission, and check for minimal residual disease to evaluate treatment impact. The study expects to last about four years with around 31 participants. Outcomes such as remission duration, survival, relapse rates, and safety events will be assessed during treatment and follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Diagnosed with Acute Myeloid Leukemia (including de novo, secondary, or AML from MDS)
In complete remission (CR, CRi, or CRh) with less than 5% leukemia cells in bone marrow
Evidence of CD123 positive cells by central assessment
Measurable disease of at least 0.1% by flow cytometry
ECOG performance status of 0 to 2
Adequate organ and marrow function as defined by specific laboratory limits
Albumin level of at least 3.2 g/dL
Left ventricular ejection fraction at or above institutional lower limit within 30 days before treatment
Negative pregnancy test for women of childbearing potential and agreement to use contraception
Willing and able to follow study visit schedules and protocol requirements

You will not qualify if you...

Prior treatment with CD123-targeted therapy
Diagnosis of acute promyelocytic leukemia
Received intensive chemotherapy within 2 weeks before study start or venetoclax within 5 days
Imminent stem cell transplant planned
History of prior allogeneic stem cell transplant
Uncontrolled serious lung disease
Past severe capillary leak syndrome
Active hepatitis B or C with detectable viral load
Known HIV infection with detectable viral load
Concurrent or recent malignancy within 6 months except certain treated cancers
Uncontrolled fungal, bacterial, or viral infections
Severe heart disease with NYHA Class III or IV symptoms
Evidence of ongoing alcohol or drug abuse
Active or symptomatic central nervous system involvement
Use of moderate or strong CYP3A inducers within 7 days before treatment
Consumption of grapefruit, Seville oranges, or star fruit within 3 days before treatment
Pregnant or breastfeeding women due to potential risks to baby

Research Team

Jacqueline Garcia, MD

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