A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia
A Phase II Clinical Trial of Olutasidenib in Patients With Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
Kissei Pharmaceutical Co., Ltd.
3 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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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Interventions
Olutasidenib: Oral administration
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07604064