Multi-Site Cancer Trial: Targeting Residual Disease in Acute Myeloid Leukemia with Tagraxofusp, Azacitidine, and Venetoclax
Sponsor: Jacqueline Garcia, MD
ClinicalTrials ID:NCT07148180
This study is testing a new combination of three drugs to see if they can safely control leftover leukemia cells in patients with Acute Myeloid Leukemia (AML) and prevent the disease from coming back.
Patient Parameters
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Program Overview
The study aims to find out if a combination of three drugs—Tagraxofusp, Azacitidine, and Venetoclax—can safely help control leftover leukemia cells in patients with Acute Myeloid Leukemia (AML) and prevent the disease from returning. These leftover cells are not visible to the eye but can increase the risk of the disease coming back. The study will test the safety and effectiveness of this drug combination.
Description
This clinical trial is in Phase 1/2 and involves testing a new combination of three drugs: Tagraxofusp, Azacitidine, and Venetoclax. The goal is to see if these drugs can safely control leftover leukemia cells in patients with Acute Myeloid Leukemia (AML) and prevent the disease from returning.
In Phase 1, the study will determine the safest dose of Tagraxofusp to use with Azacitidine and Venetoclax. In Phase 2, the study will test this dose to see how well it works.
The U.S. Food and Drug Administration (FDA) has approved the use of Venetoclax and Azacitidine together for treating AML, and Tagraxofusp for another type of leukemia. However, the combination of all three drugs is not yet approved for AML.
Participants will undergo various procedures, including blood tests, scans, and bone marrow biopsies. The study is expected to last about 4 years and will include around 31 participants.
Stemline Therapeutics is providing the drug Tagraxofusp, and Break Through Cancer is funding the laboratory services.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a known diagnosis of Acute Myeloid Leukemia (AML).
- Must be in a state of remission with less than 5% leukemia cells in the bone marrow.
- Must have evidence of CD123+ by central assessment.
- Must have measurable disease as defined by specific tests.
- Must have a performance status score of 2 or less, indicating good overall health.
- Must have adequate organ and marrow function based on specific blood tests.
- Must have a normal heart function test within 30 days of starting treatment.
- Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after the study.
- Must be willing to follow the study schedule and requirements.
Exclusion Criteria
- Previous treatment with CD123-targeted therapy.
- Diagnosis of acute promyelocytic leukemia.
- Recent intensive chemotherapy or use of Venetoclax within 5 days before the study.
- Planned stem cell transplant that is imminent.
- History of stem cell transplant.
- Uncontrolled lung disease or significant risk for lung complications.
- History of severe capillary leak syndrome.
- Active hepatitis B or C infection unless under control.
- HIV positive unless under control.
- Recent or concurrent other cancers unless in remission for at least 6 months.
- Uncontrolled infections.
- Significant heart disease or history of heart problems.
- Ongoing alcohol or drug abuse.
- Active or symptomatic central nervous system involvement.
- Use of certain medications that affect liver enzymes within 7 days of starting the study.
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before the study.
- Pregnant or breastfeeding women.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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