Trial comparing treatments for Glioblastoma
Official title Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma
ClinicalTrials.gov ID: NCT06991101
What this study is testing
What is Ruxolitinib?
An investigational oral medicine being studied as a potential treatment for newly diagnosed glioblastoma. It is designed to inhibit JAK1 and JAK2 enzymes, which reduces signaling that can promote tumor growth.
Also referred to as Jakavi.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if ruxolitinib is safe and works better when combined with standard radiation and temozolomide for newly diagnosed glioblastoma.
- Who it's for
- Adults who have just been diagnosed with glioblastoma, regardless of MGMT gene status.
- What's involved
- Participants are randomly assigned to receive either ruxolitinib plus the usual radiation and temozolomide chemotherapy, or just the usual radiation and temozolomide. This involves taking an oral drug, undergoing radiation sessions, and receiving chemotherapy cycles, with regular check‑ups and tests.
- Time commitment
- The trial runs for several months, with multiple visits for treatment, monitoring, and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Individuals of any sex, gender, race, or ethnicity ≥ 18 years of age.
- Histologically confirmed glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype) that is either methylated...
- Must have a Karnofsky performance status (KPS) ≥ 70% (i.e., the patient must be able to care for themself with occasional help from others).
You likely can't join if
- Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the...
- Patients receiving concurrent therapy for their brain tumor (e.g., chemotherapeutics or investigational agents).
- Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell...
- Patient has previously taken ruxolitinib or is allergic to any components of the study drug.
- Patients using warfarin.
- Uncontrolled immunodeficiency virus infection or active tuberculosis.
See the full eligibility criteria
- Provision of signed informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Individuals of any sex, gender, race, or ethnicity ≥ 18 years of age.
- Histologically confirmed glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype) that is either methylated, unmethylated, or indeterminate MGMT.
- Must have a Karnofsky performance status (KPS) ≥ 70% (i.e., the patient must be able to care for themself with occasional help from others).
- Absolute neutrophil count (ANC) ≥ 1500/mm³. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.
- Platelet count ≥ 100,000/mm³. Note: Platelet transfusion is not allowed within 1 week prior to registration.
- Total bilirubin (TBL) ≤ 1.5 × institutional upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
- Serum albumin ≥ 2.5 g/dL.
- If actual body weight \< Ideal body weight (IBW), use actual body weight
- If ideal body weight \< actual body weight \< 1.25 ideal body weight, use ideal body weight
- If actual body weight ≥ 1.25 ideal body weight, use adjusted body weight
- Adjusted body weight = Ideal body weight + 0.4 (Actual body weight - ideal body weight)
- IBW: Male IBW = 50 kg + 2.3 kg per inch over 5 feet or Female IBW = 45.5 kg + 2.3 kg per inch over 5 feet \ Note: for patients whose serum creatinine exceeds 1.5 × ULN, a calculated creatinine ≥ 50 mL/min is required...
- Patients able to become pregnant: use of highly effective contraception for at least one (1) month prior to screening and agreement to use such a method.
- Patients must have no concurrent malignancy except curatively treated early-stage bladder and prostate cancer that has been completed resected, basal or squamous cell carcinoma of the skin or carcinoma in situ of the...
- The ability to swallow
- Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant.
- Patients receiving concurrent therapy for their brain tumor (e.g., chemotherapeutics or investigational agents).
- Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin.
- Patient has previously taken ruxolitinib or is allergic to any components of the study drug.
- Patients using warfarin.
- Uncontrolled immunodeficiency virus infection or active tuberculosis.
- Patients with active serious infections requiring systemic therapy.
- Known Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.
- Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, New York Heart Association (NYHA) Grade ≥2...
- Patients who have obtained the following vaccines ≤ 6 weeks prior to the start of the study: adenovirus, BCG, chikungunya, cholera, dengue, Ebola Zaire, Influenza (live/attenuated), Japanese encephalitis...
- Any other serious medical/psychiatric condition, in the judgement of the investigator, that likely to interfere or limit compliance with study requirements/treatment.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States; New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.