NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
Date of first enrollment	17/02/2026
Target sample size	3
Countries of recruitment
Study type	Interventional
Intervention(s)	Olutasidenib 150 mg will be administered orally twice daily under fasting condition.

Outcome(s)

Primary Outcome	Incidence of adverse events and adverse drug reactions
Secondary Outcome	- CR/CRh rate - Duration of CR/CRh - Time to CR/CRh - Transfusion independence - Overall survival (OS)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude criteria	- 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