OncoMatch/Clinical Trials/NCT06991101
Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma
Official title: Randomized Phase 2 Trial of Ruxolitinib in Combination With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma.
Is NCT06991101 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Ruxolitinib and Temozolomide for glioblastoma.
Treatment: Ruxolitinib · Temozolomide — The purpose of this research is to test the safety and effectiveness of the investigational drug ruxolitinib when it is combined with standard of care treatment (radiation therapy and temozolomide) for the treatment of newly diagnosed glioblastoma. Half the people in the study will be assigned to take the study drug ruxolitinib in addition to the standard of care temozolomide and radiation therapy and the other half will be assigned to the standard of care temozolomide and radiation therapy only. This assignment will be randomized in a 1-to-1 ratio, like the flip of a coin.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype)
Required: IDH2 wild-type
glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype)
Prior therapy
Cannot have received: JAK inhibitor (ruxolitinib)
Patient has previously taken ruxolitinib
Cannot have received: concurrent therapy for brain tumor
Patients receiving concurrent therapy for their brain tumor (e.g., chemotherapeutics or investigational agents)
Cannot have received: warfarin (warfarin)
Patients using warfarin
Lab requirements
Blood counts
ANC ≥ 1500/mm³ (no G-CSF within 1 week prior); platelets ≥ 100,000/mm³ (no platelet transfusion within 1 week prior)
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; serum albumin ≥ 2.5 g/dL
Adequate organ (liver and renal) and bone marrow function within 14 days before randomization. ANC ≥ 1500/mm³. Platelet count ≥ 100,000/mm³. Total bilirubin ≤ 1.5 × ULN. ALT and AST ≤ 3 × ULN. Serum albumin ≥ 2.5 g/dL. Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baptist Health Herbert Wertheim Cancer Institute · Miami, Florida
- New York University Langone's Perlmutter Cancer Institute · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06991101 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior JAK inhibitor, concurrent therapy for brain tumor, warfarin disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 wild-type is a required biomarker for enrollment.
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 qualifyRelated pages