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

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.

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