Clinical trial · Interventional
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
NCT07604064CI-TRIAL-00112710recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olutasidenib | Drug | Olutasidenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Olutasidenib
- description
- Olutasidenib will be administered orally twice daily under fasting condition.
- interventionNames
- Drug: Olutasidenib
Primary outcomes (1)
- measure
- Incidence of adverse events and adverse drug reactions
- timeFrame
- From the start of IMP administration to 28 days after the final dose of the IMP
- description
- 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.
Secondary outcomes (5)
- measure
- CR/CRh rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.