A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKissei Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Olutasidenib
Treatment groups
3 Participants
are divided into 1 treatment groupLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Research SiteRecruiting Tokyo and Other Japanese Cities
Japan
JapanSponsors and collaborators
Source ClinicalTrials.gov