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

A Phase II Clinical Trial of Olutasidenib in Patients with Acute Myeloid Leukemia

Ikezaki Yumi

Kissei Pharmaceutical Co., Ltd.

3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 1120002, Japan

rinsyousiken@pharm.kissei.co.jp

Ikezaki Yumi

Kissei Pharmaceutical Co., Ltd.

3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 1120002, Japan

+81-3-5684-3533

rinsyousiken@pharm.kissei.co.jp

Recruiting

Feb. 17, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- Patients with known IDH2 mutations or prior treatment with IDH2 inhibitors
- Patients who are intolerant to IDH1 inhibitors
- Patients who are judged ineligible for the clinical trial by the principal investigator or subinvestigator

Both

Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia

Olutasidenib 150 mg will be administered orally twice daily under fasting condition.

Incidence of adverse events and adverse drug reactions

- CR/CRh rate
- Duration of CR/CRh
- Time to CR/CRh
- Transfusion independence
- Overall survival (OS)

Feb. 17, 2026

Yes

- The Individual Patient Data (IPD) are available upon reasonable request and with permission of Kissei Pharmaceutical Co., Ltd. - For a data sharing request for IPD, please contact Kissei Pharmaceutical at rinsyousiken@pharm.kissei.co.jp.

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