OncoMatch/Clinical Trials/NCT06161974
Study of Olutasidenib and Temozolomide in HGG
Is NCT06161974 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Other
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Biomarker criteria
Required: IDH1 r132h
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene: R132H, R132C, R132S, R132G or R132L
Required: IDH1 r132c
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene: R132H, R132C, R132S, R132G or R132L
Required: IDH1 r132s
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene: R132H, R132C, R132S, R132G or R132L
Required: IDH1 r132g
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene: R132H, R132C, R132S, R132G or R132L
Required: IDH1 r132l
Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene: R132H, R132C, R132S, R132G or R132L
Disease stage
Required: Stage WHO GRADE 3, WHO GRADE 4 (other)
All other HGG must be WHO Grade 3 or 4. Measurable disease is not required. Patients without measurable disease are eligible.
Demographics
Prior therapy
Cannot have received: anticancer therapy for HGG
Exception: surgery, radiation, dexamethasone, temozolomide (concurrent with RT), bevacizumab (if ≥42-day washout)
No other prior anticancer therapy for HGG will be allowed.
Cannot have received: investigational drug
Patients who are currently receiving another investigational drug are not eligible.
Cannot have received: concurrent anti-cancer agents
Exception: temozolomide given concurrently with RT and as protocol-instructed post RT maintenance therapy after enrollment on TarGeT-D
Concurrent anti-cancer agents are not allowed with the exception of temozolomide given concurrently with RT and as protocol-instructed post RT maintenance therapy after enrollment on TarGeT-D.
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3; Platelet count ≥ 100,000/mm3 (transfusion independent, not receiving platelet transfusions for at least 7 days prior to enrollment); 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, Renal Function, Liver Function as defined in protocol
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
- University of Miami Hospital and Clinics · Miami, Florida
- Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, Illinois
- Susan Chi · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06161974 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anticancer therapy for HGG, investigational drug, concurrent anti-cancer agents disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 r132h is a required biomarker for enrollment.
Does this trial require IDH1?
Yes, IDH1 r132c is a required biomarker for enrollment.
Does this trial require IDH1?
Yes, IDH1 r132s is a required biomarker for enrollment.
What disease stage is eligible?
Stage WHO GRADE 3 or WHO GRADE 4 is required.
Is there an age limit?
Yes. Patients must be 39 years or younger and at least 12 years old.
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