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Clinical trialNCT06161974RecruitingPhase 2Interventional

Study of Olutasidenib and Temozolomide in HGG

SponsorRigel PharmaceuticalsEnrollment60AstrocytomaAstrocytoma, Grade IIIAstrocytoma, Grade IVDiffuse Intrinsic Pontine GliomaDiffuse Midline Glioma, H3 K27M-MutantHigh Grade Glioma+13 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

20 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Sydney Children'S Hospital

    Randwick, New South Wales, Australia

    Recruiting
  • Queensland Children'S Hospital

    South Brisbane, Queensland, Australia

    Not, yet, recruiting
  • Perth Children'S Hospital

    Perth, Western Australia, Australia

    Recruiting
Canada
  • the Hospital for Sick Children (sickkids)

    Toronto, Ontario, Canada

    Not, yet, recruiting
  • Montreal Children'S Hospital

    Montreal, Quebec, Canada

    Not, yet, recruiting
Germany
  • Hopp Children'S Cancer Center at Nct Heidelberg (kitz)

    Heidelberg, Baden-Wurttemberg, Germany

    Not, yet, recruiting
Netherlands
  • Princess Máxima Center

    Utrecht, Netherlands

    Not, yet, recruiting
New Zealand
  • Starship Children'S Hospital

    Auckland, Grafton, New Zealand

    Not, yet, recruiting
United Kingdom
  • Great Ormond Street Hospital

    London, United Kingdom

    Not, yet, recruiting
United States
  • Children'S Hospital Colorado

    Aurora, Colorado, United States

    Not, yet, recruiting
  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

    Not, yet, recruiting
  • University of Miami Hospital and Clinics

    Miami, Florida, United States

    Recruiting
  • Ann & Robert H. Lurie Children'S Hospital of Chicago

    Chicago, Illinois, United States

    Recruiting
  • Susan Chi

    Boston, Massachusetts, United States

    Not, yet, recruiting
  • Duke University Health System

    Durham, North Carolina, United States

    Recruiting
  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

    Recruiting
  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

    Recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Not, yet, recruiting
  • Texas Children'S Hospital

    Houston, Texas, United States

    Not, yet, recruiting
  • Seattle Children'S Hospital

    Seattle, Washington, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Olutasidenib + TMZ
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Feb 2025
Primary completion
30 Jun 2029
Completion
30 Jun 2035
Last update posted
12 Jun 2026
Registered enrollment
60
Registry id
NCT06161974

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.