Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
Conditions
Brief summary
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.
Interventions
DRUGOlutasidenib
Olutasidenib: Oral administration
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events and adverse drug reactions | From the start of IMP administration to 28 days after the final dose of the IMP | 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
| Measure | Time frame | Description |
|---|---|---|
| CR/CRh rate | Through study completion, approximately up to 3 years | The number and proportion of patients who achieve CR or CRh |
| Duration of CR/CRh | Through study completion, approximately up to 3 years | The duration from the achievement of the first CR or CRh to relapse or death, whichever occurs first |
| Time to CR/CRh | Through study completion, approximately up to 3 years | The duration from the start of IMP administration to the achievement of CR or CRh |
| Transfusion independence | Through study completion, approximately up to 3 years | The number and proportion of patients who have been transfusion-free for 28 days and 56 days after the start of IMP |
| Overall survival (OS) | Through study completion, approximately up to 3 years | The duration from the start of IMP administration to death for any reason |
Countries
Japan
Contacts
CONTACTKissei Pharmaceutical Co., Ltd
STUDY_DIRECTORYumi Ikezaki
Kissei Pharmaceutical Co., Ltd.
Outcome results
None listed