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NCT06161974 · ClinicalTrials.gov registry record · Phase 2
Study of Olutasidenib and Temozolomide in HGG
A Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Rigel Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 18
- Study locations
NCT06161974: Recruiting Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Rigel Pharmaceuticals.
NCT06161974 is a Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma that is actively recruiting participants, run by Rigel Pharmaceuticals. The registered enrollment target is 60 participants, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target. The trial reports 18 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06161974, a Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, is actively recruiting participants, sponsored by Rigel Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
To identify the dose of olutasidenib that is feasible when given post-RT in combination with temozolomide as maintenance therapy in pediatric and young adult patients newly diagnosed with IDH1-mutant high-grade glioma
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 |
What NCT06161974 shows while recruiting
NCT06161974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target.
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.
NCT06161974 lists 18 locations in 16 states (Ohio, Other, Colorado).
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.
What interventions are being tested in trial NCT06161974?
The interventions under investigation include: Olutasidenib + TMZ (DRUG).
Who is sponsoring clinical trial NCT06161974?
This trial is sponsored by Rigel Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for High Grade Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06161974's enrollment target sits among peer trials
60 11th of 42 higher than 32 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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