OncoMatch/Clinical Trials/NCT06161974
Study of Olutasidenib and Temozolomide in HGG
Is NCT06161974 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Olutasidenib + TMZ for high grade glioma.
Treatment: Olutasidenib + TMZ — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Biomarker criteria
Required: IDH1 R132H
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here: R132H, R132C, R132S, R132G or R132L.
Required: IDH1 R132C
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here: R132H, R132C, R132S, R132G or R132L.
Required: IDH1 R132S
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here: R132H, R132C, R132S, R132G or R132L.
Required: IDH1 R132G
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here: R132H, R132C, R132S, R132G or R132L.
Required: IDH1 R132L
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here: R132H, R132C, R132S, R132G or R132L.
Excluded: IDH2 mutation
Patients with IDH2 mutations are not eligible.
Disease stage
Required: Stage WHO GRADE 3, WHO GRADE 4 (WHO)
All other HGG must be WHO Grade 3 or 4. Measurable disease is not required. Patients without measurable disease are eligible. Patient must not have metastatic disease.
Prior therapy
Must have received: radiation therapy — definitive
RT, delivered via photon or proton beam, must have been administered at a standard dose including 54 Gy in 30 fractions for DIPG, 59.4 Gy in 33 fractions or 54-60 Gy in 30 fractions for other HGG or 45-50.4 Gy for primary spinal disease. Any variances in the radiotherapy dose within 10% of the standard doses outlined above will be discussed with the Study Chair to confirm eligibility prior to study enrollment.
Cannot have received: anticancer therapy (other than surgery, radiation, dexamethasone, or temozolomide with RT)
Exception: Temozolomide administered concurrently with radiotherapy is permissible.
No other prior anticancer therapy for HGG will be allowed.
Lab requirements
Blood counts
ANC ≥ 1000/mm3; Platelet count ≥ 100,000/mm3 (transfusion independent); Hemoglobin > 8 g/dL (may be transfused)
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR maximum serum creatinine based on age/gender
Liver function
Total bilirubin ≤ 1.5 × institutional ULN; AST(SGOT)/ALT(SGPT) < 3 × institutional ULN; Alkaline Phosphatase < 3 × institutional ULN
Adequate Bone Marrow Function... Adequate Renal Function... Adequate Liver Function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Colorado · Aurora, Colorado
- Children's National Medical Center · Washington D.C., District of Columbia
- Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, Illinois
- Susan Chi · Boston, Massachusetts
- Duke University Health System · Durham, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify