NCT07604064RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (estimated)
- First submitted
- 18 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 Sept 2030
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07604064
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 3
- From 1 Jun 2026 to the primary completion date, 30 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are intolerant to IDH1 inhibitors
Other illness
- Patients with IDH2 mutations or patients with a history of IDH2 inhibitor treatment
Other
- Patients who are deemed inappropriate for the clinical trial by the investigator or sub-investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Tokyo and Other Japanese Cities | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.