Olutasidenib, Venetoclax, and Azacitidine for IDH1-Mutated Acute Myeloid Leukemia

This study is testing a combination of three drugs – olutasidenib, venetoclax, and azacitidine – for people with newly diagnosed Acute Myeloid Leukemia (AML) that has an IDH1 mutation. Researchers want to see if this combination causes fewer or more side effects, and how well it works compared to standard chemotherapy. You may be eligible if you are between 18 and 75 years old, have an IDH1 mutation, and are able to receive intensive chemotherapy. The study aims to measure how many participants experience too many side effects within 12 months, and how many achieve a complete remission within 3 months. The current status of this study is unclear, and it plans to enroll 16 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 16 participants, and the phase is not specified.
What's involved
You would receive olutasidenib capsules twice daily, venetoclax tablets once daily with a meal, and azacitidine injections or infusions on specific days of each cycle.
Compensation
Not stated in the trial record.
Follow-up
The study will measure excessive toxicity for up to 12 months and complete remission for up to 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06782542

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Justin Watts, MD
~16 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:OlutasidenibVenetoclaxAzacitidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Excessive Toxicity
Measured over Up to 12 months
+1 more outcome measured
Acute Myeloid Leukemia
IDH1 Mutation
1 sites across 1 states
Florida1
  • Justin Watts, MD · PRINCIPAL_INVESTIGATOR · University of Miami

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  • Number of Participants Experiencing Excessive ToxicityUp to 12 months

    The number of participants experiencing excessive toxicity in six (6) patient safety lead-in over the duration of study treatment will be reported. All treatment-emergent adverse events (TEAEs) will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  • Composite Complete Remission (CRc)Up to 3 months

    Composite complete remission (CRc) among participants will be reported as a percentage. CRc is includes number of participants experiencing complete remission \[CR\], complete remission with partial hematologic recovery \[CRh\] or complete remission with incomplete hematologic recovery \[CRi\] after up to 3 cycles as defined by modified 2022 European LeukemiaNet (ELN) criteria.