Actively Recruiting
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
Led by Jacqueline Garcia, MD · Updated on 2026-02-05
31
Participants Needed
2
Research Sites
256 weeks
Total Duration
On this page
Sponsors
J
Jacqueline Garcia, MD
Lead Sponsor
S
Stemline Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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
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 with less than 5% bone marrow blasts
- Evidence of CD123 positive disease by central testing
- Measurable disease at or above 0.1% by flow cytometry
- ECOG performance status of 2 or less
- Adequate organ and marrow function including bilirubin, liver enzymes, kidney function, and albumin levels
- Left ventricular ejection fraction at or above the institutional lower limit within 30 days prior to treatment
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception
- Willing and able to follow study visit schedule and requirements
You will not qualify if you...
- Prior treatment with CD123-targeted therapies
- Diagnosis of acute promyelocytic leukemia
- Intensive anti-leukemic chemotherapy within 2 weeks before study start; venetoclax stopped at least 5 days prior
- Imminent stem cell transplant planned
- History of allogeneic stem cell transplant
- Uncontrolled significant lung disease
- Past severe capillary leak syndrome
- Active hepatitis B or C with detectable viral load
- Known HIV positive without undetectable viral load
- Concurrent or recent malignancy within 6 months unless well controlled or treated
- Uncontrolled infections
- Severe heart disease with Class III or IV symptoms
- Evidence of alcohol or drug abuse
- Active symptomatic central nervous system involvement
- Use of strong CYP3A inducers within 7 days before treatment
- Uncontrolled other illnesses
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before first dose
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Jacqueline Garcia, MD
CONTACT
J
Jacqueline Garcia, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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