A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia
Recruiting
Phase 2
Interventional Study
Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 3 (estimated)
- Sponsor
- Kissei Pharmaceutical Co., Ltd. · Industry
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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.
Trial Locations
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Eligibility Criteria
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 re…
Contacts