Recruiting

OLUVENAZAOlutasidenib, Venetoclax, and Azacitidine for IDH1 Mutated Acute Myeloid Leukemia

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What is being tested

Olutasidenib

+ Venetoclax

+ Azacitidine

Drug
Who is being recruted

Hematologic Diseases+4

+ Hemic and Lymphatic Diseases

+ Leukemia

From 18 to 75 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorJustin Watts, MD
Study ContactJustin Watts, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2026

Actual date on which the first participant was enrolled.

This study investigates a new treatment for people with a form of blood cancer known as acute myeloid leukemia (AML) that has a specific genetic mutation called IDH1. The study focuses on patients who are newly diagnosed and eligible for intensive chemotherapy. The aim is to evaluate if a combination of three drugs—olutasidenib, venetoclax, and azacitidine—can offer a more effective and less harmful alternative to standard chemotherapy. By exploring this new treatment approach, the study hopes to find better options for managing this challenging condition. Participants in the study receive the combination treatment of olutasidenib, venetoclax, and azacitidine. The treatment's effects are observed and compared to those of traditional chemotherapy to see how well it works and what side effects might occur. The researchers are particularly interested in knowing if the new treatment leads to more, fewer, or similar side effects compared to standard care. The results are measured by monitoring the participants' responses to the treatment, looking at both improvements in their condition and any adverse effects experienced.

Official TitleSingle-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
NCT06782542
Principal SponsorJustin Watts, MD
Study ContactJustin Watts, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

11 inclusion criteria required to participate
Participant is an adult male or female participant aged 18-75 years considered eligible to undergo intensive induction chemotherapy at the time of signing the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Confirmed diagnosis of: 1. Newly diagnosed AML Isocitrate dehydrogenase 1 (IDH1) R132 mutated disease as assessed locally. Note: historical results from within 30 days of informed consent will be accepted if the participant did not receive systemic treatment after collection. 2. Secondary AML, including prior hypomethylating agents (HMA) exposure for myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPN), or MDS/MPN is allowed.
Participant must have adequate organ function, defined by the following: 1. Aspartate transaminase (AST) and alanine aminotransferase (ALT) values ≤3 × upper limit of normal (ULN) or ≤5 × ULN for participants with leukemic involvement. 2. Bilirubin ≤2 ULN (≤3 × ULN in participants with Gilbert Syndrome) or ≤3 × ULN for participants with leukemic involvement. 3. Creatinine clearance ≥30 mL/min (using Cockcroft-Gault), or serum creatinine ≤1.5 × ULN.
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18 exclusion criteria prevent from participating
Acute promyelocytic leukemia (APL).
ELN (2022) favorable risk AML, except for nucleophosmin 1 (NPM1) mutated AML, which is allowed.
Relapsed/Refractory AML.
Positive Fms related receptor tyrosine kinase 3-Internal tandem duplication (FLT3-ITD) mutation.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group will receive combination treatment of Olutasidenib, Venetoclax and Azacitidine orally for up to 12 cycles, each cycle lasting 28 days. Total participation duration is about 14 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Miami

Miami, United StatesOpen University of Miami in Google Maps
Recruiting
One Study Center