Phase 2 Study of Olutasidenib With Temozolomide as Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations

This study is testing if a new combination of two medications can help treat children and young adults with specific fast-growing brain or spinal cord tumors. Researchers hope that adding a targeted medicine called olutasidenib to standard chemotherapy will help patients live longer and better manage their illness.

This trial is for patients aged 12 to 39 who have been newly diagnosed with a high-grade brain or spinal cord tumor containing a specific genetic change called an IDH1 mutation. Participants will need to have tissue samples available from a previous biopsy or surgery to confirm the mutation.

Participants will receive a combination of the study drug olutasidenib and a chemotherapy medication called temozolomide. Because this is a clinical trial, you will be closely monitored by a medical team to see how the treatments work and how your body responds to them.

The study is currently recruiting patients at medical centers in Aurora, Colorado; Washington, D.C.; and Miami, Florida. Because this is an active trial, interested patients should contact these locations to discuss if the study is the right fit for their specific health needs.