Actively Recruiting
Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma
Led by Baptist Health South Florida · Updated on 2025-12-26
190
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form provided
- Willing to follow all study procedures and available for the study duration
- Age 18 years or older, any sex, gender, race, or ethnicity
- Histologically confirmed glioblastoma (IDH-wildtype) by WHO 2021 criteria, any MGMT status
- Sufficient tumor tissue available for MGMT and IDH testing
- Karnofsky performance status of 70% or higher
- Adequate liver, kidney, and bone marrow function within 14 days before randomization:
- Absolute neutrophil count 1500/mm3 or higher
- Platelet count 100,000/mm3 or higher
- Total bilirubin 1.5 times or less the upper limit of normal
- ALT and AST levels 3 times or less the upper limit of normal
- Serum albumin 2.5 g/dL or higher
- If able to become pregnant, use highly effective contraception for at least 1 month before screening and agree to continue use; negative pregnancy test required
- No concurrent malignancy except certain treated early-stage cancers or disease-free for 3 years from prior malignancies
You will not qualify if you...
- Pregnant or breastfeeding
- Receiving other concurrent therapy for brain tumor besides study treatments
- Concurrent or prior malignancy except certain treated skin or stage I/II cancers or disease-free for less than 3 years
- Repeat craniotomy for tumor after radiation and temozolomide treatment
- Previous use of chemotherapeutics or investigational agents beyond radiation and temozolomide
- Prior use of ruxolitinib or allergy to its components
- Current use of warfarin
- Uncontrolled HIV infection or active tuberculosis
- Active serious infections needing systemic treatment
- Active hepatitis B or C infection requiring treatment or risk of HBV reactivation
- Significant heart conditions or abnormal EKG including recent heart failure, arrhythmia, or thrombosis within 6 months
- Other serious medical or psychiatric conditions limiting compliance, as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
M
Manmeet Ahluwalia, M.D., MBA
CONTACT
M
MCI Multisite Research Program
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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