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Olutasidenib for IDH1-Mutated AML After Venetoclax

This study is testing a drug called olutasidenib for people with acute myeloid leukemia (AML), a type of blood cancer, that has a specific change called an IDH1 mutation. This trial is for patients whose AML has come back or not responded to previous treatment, specifically after receiving venetoclax. You would take olutasidenib by mouth twice a day. After three cycles, if your cancer hasn't fully responded, another drug called azacitidine might be added. The main goal is to see how many people have a complete remission (when signs of cancer disappear) within two years. The study plans to enroll 25 participants, and its current status is unclear.

Study design
This is a Phase 2 pilot study, meaning it's an early-stage study looking at effectiveness, and it involves a single group of participants. It plans to enroll 25 people.
What's involved
You would take olutasidenib orally twice daily for 28-day cycles. Azacitidine might be added after 3 cycles, given subcutaneously or intravenously for 7 days.
Compensation
Not stated in the trial record.
Follow-up
The study measures the complete remission rate at 2 years, suggesting follow-up for at least that long.

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NCT07471841

Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

Recruiting
PHASE2Ages 18+InterventionalTreatment
Timothy Pardee
~25 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:OlutasidenibAzacitidine (AZA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite complete remission rate
Measured over 2 years

Conditions

IDH1 Mutation
Relapsed / Refractory AML

Explore related trials

Acute Myeloid LeukemiaIDH1 Gene

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Timothy Pardee, MD, PhD · PRINCIPAL_INVESTIGATOR · Atrium Health Wake Forest Baptist

Who to contact

Timothy Pardee
[email protected]
MD, PhD
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Renal
Calculated creatinine clearance (Cockcroft-Gault formula will be used to calculate creatinine clearance) ≥ 30 mL/min
Hepatic
Total bilirubin2 ≤ 2× upper limit of normal (ULN); ≤ 3 times ULN in patients with Gilbert Syndrome
Aspartate aminotransferase (AST) ≤ 5 × ULN
Alanine aminotransferase (ALT) ≤ 5× ULN 9. Participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment. 10. Participants of childbearing potential who are having penile-vaginal intercourse with a person able to father a child must be willing to abstain from penile-vaginal intercourse or must use an effective method(s) of contraception. A participant able to father a child who is having penile-vaginal intercourse with a person of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception. 11. Subjects with known HIV infection may be eligible if they are on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration. Testing is not required at screening. 12. Subjects with known chronic hepatitis B virus (HBV) infection may be eligible if they have an undetectable HBV viral load on suppressive therapy, if indicated. Subjects with a history of hepatitis C virus (HCV) infection may be eligible if they have been treated and cured. Subjects with an HCV infection who are currently on treatment must have an undetectable HCV viral load to be eligible for this trial. Testing is not required at screening. 13. As determined by the investigator or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

What this trial measures

  • Composite complete remission rate2 years

    Composite complete remission (CRc) rate is defined as patients that meet the criteria for CR + CRh + CRi per the modified European LeukemiaNet (mELN) 2022. * Complete Remission (CR) is defined as absence of leukemia cells in the bone marrow (\< 5% blasts), normal blood counts (absolute neutrophil count ≥ 1000/μL and platelet count ≥ 100,000/μL), and the absence of circulating blasts, and extramedullary disease * Complete Remission with Hematologic recovery (CRh) is defined as meeting all criteria for CR as Bone marrow myeloblasts \< 5%; absence of circulating blasts; absence of extramedullary disease; both ANC ≥ 0.5x109/L (500/µL) and platelet count ≥ 50×109/L (50 000/µL) * Complete Remission with Incomplete hematologic recovery (CRi) is defined as meeting all criteria for Complete Remission (CR) except for either a low neutrophil count (neutropenia) or a low platelet count (thrombocytopenia)