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Study of Olutasidenib and Temozolomide in HGG
NCT06161974 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Olutasidenib + TMZ
Study Locations (18)
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Nationwide Children's Hospital — Columbus
Other
- Princess Máxima Center — Utrecht
- Great Ormond Street Hospital — London
Colorado
- Children's Hospital Colorado — Aurora
District of Columbia
- Children's National Medical Center — Washington D.C.
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Massachusetts
- Susan Chi — Boston
North Carolina
- Duke University Health System — Durham
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-03 |
| Est. Completion | 2035-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06161974
The ClinicalTrials.gov registry entry for NCT06161974 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rigel Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 1 intervention — of which Olutasidenib + TMZ is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06161974 reports 18 study locations spanning 16 distinct geographic areas — top geographies include Ohio, Other, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06161974 about?
NCT06161974 is a clinical study titled "Study of Olutasidenib and Temozolomide in HGG". 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 temozol...
What is the current status of trial NCT06161974?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-03. Estimated completion is 2035-06.
What conditions does trial NCT06161974 study?
This clinical trial studies the following conditions: High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Astrocytoma, Diffuse Midline Glioma, H3 K27M-Mutant, WHO Grade III Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06161974?
The interventions under investigation include: Olutasidenib + TMZ (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06161974?
This trial is sponsored by Rigel Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06161974 being conducted?
This trial has 18 study locations across Colorado, District of Columbia, Illinois, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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