ClinicaliQ Trial Snapshot
- Study of Olutasidenib and Temozolomide in HGG — Recruiting • Phase II • Oncology • NCT06161974.
- What is being tested: Olutasidenib combined with temozolomide in newly diagnosed pediatric and young adult patients with IDH1-mutant high-grade gliomas (HGG), evaluating whether this targeted approach improves treatment efficacy compared to standard care.
- Patient eligibility overview: The trial enrolls children and young adults with newly diagnosed HGG that carry an IDH1 mutation, representing a specific molecular subgroup within the broader HGG population.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
Eligibility Snapshot
- Criteria TarGeT-D study strata definitions * Stratum A: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 3. * Stratum B: Patients with localized, intracranial, non-pontine, and non-thalamic IDH 1 mutant Astrocytoma, CNS WHO Grade 4. * Stratum C: Patients with IDH-1 mutant DIPG, primary thalamic and spinal cord IDH-1 mutant HGG. Inclusion Criteria: 1. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on: 1.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis: * Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible. All patients must have tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR. * For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, and histopathology consistent with diffuse WHO Grade 2-4 glioma. * All other HGG must be WHO Grade 3 or 4. 1.3) Disease status: There are no disease status requirements for enrollment * Measurable disease is not required. Patients without measurable disease are eligible. *…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.