Clinical Trial

A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-18.
Trial Details
NCT Number NCT07604064
Lead Sponsor Kissei Pharmaceutical Co., Ltd.
Conditions Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
Enrollment 3 participants
Start Date 2026-06
Primary Completion 2030-09 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-27