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A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

ConditionRelapsed or Refractory IDH1 Mutation-Positive 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Olutasidenib

    Drug

    Olutasidenib: Oral administration

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: OlutasidenibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

CR/CRh rate

The number and proportion of patients who achieve CR or CRh

Time frame
Through study completion, approximately up to 3 years
2

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
3

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
4

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Research SiteRecruiting Tokyo and Other Japanese CitiesJapanJapan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kissei Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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