RecruitingPhase 2NCT07392242

A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia

A Phase II Study of IDH1 Inhibition With Ivosidenib as Maintenance Therapy After Ivosidenib, Azacitidine, and Venetoclax for Acute Myeloid Leukemia


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

45 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The researchers are doing this study to find out whether a 3-drug combination of ivosidenib, azacitidine, and venetoclax followed by maintenance therapy with ivosidenib alone is an effective treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH mutation. Maintenance therapy is additional treatment given to help keep cancer from coming back after it has disappeared following the first course of treatment. The researchers will also look at the safety of the treatment approach and what kind of a time commitment it involves for participants.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a three-drug combination — ivosidenib, azacitidine, and venetoclax — as initial treatment for older patients with a form of acute myeloid leukemia (AML) that has a specific genetic mutation called IDH1. AML is a fast-growing blood cancer, and targeted therapies like ivosidenib block the IDH1 mutation that drives tumor growth. **You may be eligible if...** - You are 60 years old or older - You have been newly diagnosed with acute myeloid leukemia (AML) - Your leukemia has the IDH1-R132 mutation (confirmed by genetic testing) - You have not yet received treatment for AML **You may NOT be eligible if...** - You have already received treatment for AML - You do not have the IDH1 mutation - You have serious heart problems (specifically QT prolongation on ECG) - You have severe liver or kidney problems - You are pregnant or breastfeeding 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

DRUGIvosidenib

Ivosidenib ( days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter)

DRUGAzacitidine

Azacitidine (IV or SC per institutional preference, days 1 through 7)

DRUGVenetoclax

Venetoclax (days 1 through 14)


Locations(7)

Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07392242


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