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RECRUITING
NCT07604064
PHASE2

A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

Sponsor: Kissei Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase II Clinical Trial of Olutasidenib in Patients With Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2026-06

Completion Date

2030-09

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

Olutasidenib

Olutasidenib: Oral administration

Locations (1)

Research Site

Tokyo and Other Japanese Cities, Japan