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A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

RecruitingPhase 2Ages 18 Years - anyAllKissei Pharmaceutical Co., Ltd.
NCT07604064 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Olutasidenib
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Where

1 site
Research Site
Tokyo and Other Japanese Cities, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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