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NCT Number: NCT07604064

A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

This clinical trial is a multicenter, single-arm, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of olutasidenib administered orally twice daily under fasting conditions for one cycle of 28 days in at least 3 Japanese patients with relapsed or refractory IDH1 mutation-positive AML.

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Key information

Conditions

Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Tokyo and Other Japanese Cities, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Japanese patients who personally provide written informed consent to participate in this clinical trial
  • Patients with a confirmed diagnosis of AML based on WHO classification (2022 edition) (except acute promyelocytic leukemia with t (15:17) translocation)
  • Patients with relapsed or refractory AML who may or may not have undergone allogeneic hematopoietic stem cell transplantation.
  • Patients with IDH1 gene mutation confirmed by central confirmation after relapse or refractoriness

Exclusion criteria

  • Patients with IDH2 mutations or patients with a history of IDH2 inhibitor treatment
  • Patients who are intolerant to IDH1 inhibitors
  • Patients who are deemed inappropriate for the clinical trial by the investigator or sub-investigator

Treatment and study plan

Olutasidenib

Drug

Olutasidenib: Oral administration

Primary outcomes

  1. Incidence of adverse events and adverse drug reactions

    Time frame: From the start of IMP administration to 28 days after the final dose of the IMP

    The number of events, number of patients, and incidence will be presented for all events, Grade 3 or higher events, Grade 4 or higher events, events resulting in death, serious events excluding death, events resulting in drug withdrawal, and events resulting in drug interruption.

Secondary outcomes

  1. CR/CRh rate

    Time frame: Through study completion, approximately up to 3 years

    The number and proportion of patients who achieve CR or CRh

  2. Duration of CR/CRh

    Time frame: Through study completion, approximately up to 3 years

    The duration from the achievement of the first CR or CRh to relapse or death, whichever occurs first

  3. Time to CR/CRh

    Time frame: Through study completion, approximately up to 3 years

    The duration from the start of IMP administration to the achievement of CR or CRh

  4. Transfusion independence

    Time frame: Through study completion, approximately up to 3 years

    The number and proportion of patients who have been transfusion-free for 28 days and 56 days after the start of IMP

  5. Overall survival (OS)

    Time frame: Through study completion, approximately up to 3 years

    The duration from the start of IMP administration to death for any reason

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase II Clinical Trial of Olutasidenib in Patients With Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 22, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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