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Recruiting NCT07604064

A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia

Phase II Interventional Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Olutasidenib.
Who it may be relevant to
Registry conditions: Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Olutasidenib
    Olutasidenib: Oral administration

Primary outcome measures

  • Incidence of adverse events and adverse drug reactions [Time frame: From the start of IMP administration to 28 days after the final dose of the IMP]
Secondary outcome measures (5)
  • CR/CRh rate [Time frame: Through study completion, approximately up to 3 years]
  • Duration of CR/CRh [Time frame: Through study completion, approximately up to 3 years]
  • Time to CR/CRh [Time frame: Through study completion, approximately up to 3 years]
  • Transfusion independence [Time frame: Through study completion, approximately up to 3 years]
  • Overall survival (OS) [Time frame: Through study completion, approximately up to 3 years]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Research Site — Tokyo and Other Japanese Cities

Identifiers

NCT: NCT07604064 · OLT1201 · jRCT2051260041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗