Olutasidenib for Acute Myeloid Leukemia With an IDH1 Mutation That Returned or Resisted Treatment
Tests olutasidenib in adults whose IDH1-mutated acute myeloid leukemia returned or resisted treatment.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia
Key facts
- Where
- Tokyo and Other Japanese Cities, JapanSee the site
- Phase
- Phase 2
Where in Japan
- Tokyo and Other Japanese CitiesTokyo and Other Japanese Cities, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kissei Pharmaceutical Co., Ltd.
- Trial code
- NCT07604064
- Record updated
- 27 May 2026
- Original description
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.Read full original descriptionShow less
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: 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: Patients who are intolerant to IDH1 inhibitors; Patients with IDH2 mutations or patients with a history of IDH2 inhibitor treatment; Patients who are deemed inappropriate for the clinical trial by the investigator or sub-investigator.