A Phase 2 interventional study of Olutasidenib in Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia, sponsored by Kissei Pharmaceutical Co., Ltd.. Recruiting at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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.
Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 63 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Olutasidenib will be administered orally twice daily under fasting condition.
Drug: Olutasidenib
Olutasidenib: Oral administration
Incidence of adverse events and adverse drug reactions
The number of events, number of patients, and incidence will be presented for all events, Grade 3 or higher events, Grade 4 or higher events, events resulting in death, serious events excluding death, events resulting in drug withdrawal, and events resulting in drug interruption.
Time frame: From the start of IMP administration to 28 days after the final dose of the IMP
CR/CRh rate
The number and proportion of patients who achieve CR or CRh
Time frame: Through study completion, approximately up to 3 years
Duration of CR/CRh
The duration from the achievement of the first CR or CRh to relapse or death, whichever occurs first
Time frame: Through study completion, approximately up to 3 years
Time to CR/CRh
The duration from the start of IMP administration to the achievement of CR or CRh
Time frame: Through study completion, approximately up to 3 years
Transfusion independence
The number and proportion of patients who have been transfusion-free for 28 days and 56 days after the start of IMP
Time frame: Through study completion, approximately up to 3 years
Overall survival (OS)
The duration from the start of IMP administration to death for any reason
Time frame: Through study completion, approximately up to 3 years
Plan to share: 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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Studies of the drug tested here: Olutasidenib
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