Phase 2 Study of Olutasidenib and Temozolomide to Treat Pediatric and Young Adult Patients Aged 12 to 39 With Newly Diagnosed High-Grade IDH1-Mutant Glioma Including DIPG

What this Trial Is About

Researchers are exploring the effectiveness of olutasidenib combined with temozolomide TMZ to treat pediatric and young adult patients newly diagnosed with high-grade glioma HGG that has an IDH1 mutation. This phase II international study focuses on whether this combination can extend progression-free survival in these patients compared to matched historical controls. The study also evaluates objective radiographic response rates, specific toxicities, and pharmacokinetics of olutasidenib. Participants receive maintenance therapy after completing focal radiotherapy. Initially, patients undergo treatment with olutasidenib and TMZ together for 13 cycles, each cycle lasting 28 days. This is followed by another 13 cycles of olutasidenib alone. The study includes a feasibility cohort to determine the recommended dose of olutasidenib when combined with TMZ. Patients are grouped into strata based on tumor grade and location, including Grade 3 and Grade 4 astrocytomas and IDH1-mutant diffuse intrinsic pontine glioma DIPG. During the trial, participants are monitored through clinical evaluations, imaging scans, and laboratory tests to assess disease progression, drug levels, and side effects. Researchers measure progression-free survival over up to 24 months and overall survival for some groups up to 60 months. Quality of life outcomes are also assessed throughout treatment. The total study period includes treatment and follow-up phases to carefully observe safety, drug response, and long-term outcomes.

Study of Olutasidenib and Temozolomide in HGG