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New treatment option for Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
Official title A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07604064
What this study is testing
What is Olutasidenib?
Olutasidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for relapsed or refractory idh1 mutation-positive acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tokyo and Other Japanese Cities, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tokyo and Other Japanese Cities, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.