RecruitingPhase 2NCT07304011

Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent

A Phase 2 Study of Olutasidenib in Combination With Azacitidine Followed by Olutasidenib Maintenance After Venetoclax Plus a Hypomethylating Agent Regimen (HMA-VEN) for IDH1-Mutated Acute Myeloid Leukemia (AML)


Sponsor

University of California, Davis

Enrollment

28 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for a type of acute myeloid leukemia (AML) — a blood cancer — in patients whose cancer carries a specific gene mutation called IDH1. The treatment combines a drug called olutasidenib (which targets the IDH1 mutation) with azacitidine (a chemotherapy drug), followed by olutasidenib alone as maintenance therapy. It is specifically for patients who have already responded well to their first treatment. **You may be eligible if...** - You have been diagnosed with AML (not the rare APL subtype) with a confirmed IDH1-R132 mutation - You achieved a complete remission after your first-line treatment with venetoclax plus a hypomethylating agent (a specific combination therapy) - You are 18 or older and in good enough overall health **You may NOT be eligible if...** - Your AML does not have the IDH1-R132 mutation - You did not achieve complete remission after first-line treatment - You have the APL (acute promyelocytic leukemia) subtype with the t(15;17) translocation - You have serious organ problems or active infections - 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

DRUGAzacitidine

Given IV or SC

DRUGOlutasidenib

Given PO


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT07304011


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