Study of Olutasidenib and Temozolomide in HGG

ClinicalTrials.gov ID: NCT06161974

Public ClinicalTrials.gov record NCT06161974. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 9, 2026, 1:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 2 Study of Olutasidenib With Temozolomide as Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06161974
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Rigel Pharmaceuticals; Industry
Enrollment: 60 participants

Conditions and interventions

Eligibility (public fields only)

Age range: 12 Years to 39 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 31, 2025
Primary completion: May 31, 2029
Completion: May 31, 2035
Last update posted: Aug 31, 2026

2025 – 2035

United States locations

U.S. sites: 11
U.S. states: 10
U.S. cities: 11

Facility	City	State	ZIP	Site status
Children's Hospital Colorado	Aurora	Colorado	80045	Not yet recruiting
Children's National Medical Center	Washington D.C.	District of Columbia	20010	Not yet recruiting
University of Miami Hospital and Clinics	Miami	Florida	33136	Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	60611	Recruiting
Susan Chi	Boston	Massachusetts	02215	Not yet recruiting
Duke University Health System	Durham	North Carolina	27708	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	43235	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Not yet recruiting
Texas Children's Hospital	Houston	Texas	77030	Not yet recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06161974, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 31, 2026 · Synced Sep 9, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06161974 live on ClinicalTrials.gov.

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