Study on the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone for Treating Acute Myeloid Leukemia
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07392242
This clinical trial is exploring a new treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has a specific IDH mutation. The study will test a combination of three drugs—ivosidenib, azacitidine, and venetoclax—followed by maintenance therapy with ivosidenib alone to see if it effectively treats AML and prevents it from returning.
Patient Parameters
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Program Overview
The purpose of this study is to determine if a combination of three drugs—ivosidenib, azacitidine, and venetoclax—followed by ongoing treatment with ivosidenib alone, is an effective way to treat people with newly diagnosed acute myeloid leukemia (AML) that has a specific IDH mutation. The study will also assess the safety of this treatment and the time commitment required for participants.
Eligibility Criteria
Inclusion Criteria
- Must be at least 60 years old.
- Willing and able to follow the study schedule and requirements.
- Have a new diagnosis of acute myeloid leukemia (AML) according to specific medical guidelines.
- Have an IDH1-R132 mutation confirmed by specific genetic tests.
- Have a performance status score between 0 and 3, indicating varying levels of activity.
- White blood cell count must be below 25,000/μL before starting the study treatment.
- Have adequate organ function, including liver and kidney function, as determined by specific blood tests.
Exclusion Criteria
- Have acute promyelocytic leukemia.
- Have previously received ivosidenib or venetoclax.
- Are receiving other experimental cancer treatments, except for certain allowed therapies.
- Have severe, life-threatening complications from leukemia.
- Have an active, uncontrolled infection despite treatment.
- Are planned for a stem cell transplant based on doctor's assessment.
- Have significant heart disease within the last 6 months.
- Have active infections with HIV, hepatitis B, or hepatitis C without improvement.
- Have conditions that affect the ability to swallow or absorb oral medications.
- Have a heart condition that affects the QT interval on an ECG.
- Are not willing to follow contraceptive guidelines during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | 11553 | Rockville Centre | New York |
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