RecruitingPhase 2NCT06782542

Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy

Single-Arm Phase 2 Study of Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Who Are Eligible for Intensive Induction Chemotherapy

Sponsor

Justin Watts, MD

Enrollment

16 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia IDH1 Mutation

Summary

The purpose of this study is as follows: 1. Determine whether people receiving the combination treatment of olutasidenib, venetoclax, and azacitidine have the same, more, or fewer side effects compared to the usual chemotherapy treatment that people with this condition receive. 2. Determine how well the combination treatment of olutasidenib, venetoclax, and azacitidine works compared to the usual chemotherapy treatment that people with this condition receive.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — olutasidenib, venetoclax, and azacitidine — for newly diagnosed acute myeloid leukemia (AML) that carries a specific genetic mutation called IDH1 R132. Olutasidenib specifically targets this mutation, while the other two drugs help attack the cancer in different ways. **You may be eligible if...** - You are between 18 and 75 years old - You have newly diagnosed AML with the IDH1 R132 mutation - You are healthy enough to receive intensive chemotherapy - Your liver and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have active or uncontrolled infections - You have certain heart rhythm problems or significant heart disease - You are pregnant or breastfeeding - You have received prior treatment for AML (some exceptions apply for prior MDS treatment) 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

DRUGOlutasidenib

Olutasidenib will be supplied as 150 mg capsules to be administered orally, twice per day (BID) on an empty stomach (fasting at least 1 hour before or 2 hours after a meal), starting on Cycle 1 Day 1, and will be given continuously.

DRUGVenetoclax

Participants will receive Venetoclax as a 100mg tablet to be self-administered orally with a meal and water once daily, two hours after starting Olutasidenib administration, starting on Cycle 1 Day 1. The dosing regimen of Venetoclax is as follows: * Cycle 1: Days 1 - 21 over a 28-day cycle * Cycle 1 Week 1: Ramp-up dosing schedule up to 400mg (4 x 100mg/tablet) * For participants with blast clearance: Cycle 2 and beyond: Days 1 - 14 over a 28-day cycle * For participants with persistent clearance: Cycle 2 through 4: Days 1 - 21

DRUGAzacitidine

Participants will receive Azacitidine 75 mg/m2 per day via subcutaneous (SC) injection or intravenous (IV) infusion on Days 1-7 of each cycle.

Locations(1)

University of Miami

Miami, Florida, United States

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NCT06782542

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