Venous Thromboembolism Prevention in Outpatients With Glioma

Study Purpose

This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Histologic diagnosis of malignant glioma, World Health Organization (WHO) grade 4, including glioblastoma and astrocytoma, based on recent biopsy or resection.

- Age 18 and old.

- Karnofsky performance status (KPS) 60-100.

- Acceptable labs, including platelets of greater than or equal to 100,000, glomerular filtration rate (GFR) greater than or equal to 25.

- Ability to provide informed consent.

- Planning for treatment with radiation and chemotherapy.

Exclusion Criteria:

- Evidence of deep venous thrombosis (DVT), pulmonary embolism (PE), or cerebral vein thrombosis (CVT) within 6 months prior to enrollment on the study.

- Pregnancy.

- Significant bleeding risk including: history of symptomatic intracranial hemorrhage, active bleeding at time of study registration, clinically significant bleeding within 14 days of study registration, intracranial trauma in the past 6 months, including stroke or traumatic brain injury, major surgery or major procedure within 48 hours.

- Allergy to apixaban or contraindication to prophylactic anticoagulation.

Contraindications include patients who are currently on unfractionated heparin, low molecular weight heparin, heparin derivatives (examples: fondaparinux), or other direct oral anticoagulants (examples: dabigatran, edoxaban, rivaroxaban), who are either unable or unable to discontinue these agents in favor of the investigational drug. Apixaban is also contraindicated in patients who are on strong CYP3A4 inhibitor and P-glycoprotein inhibitors.

- Indication for full anticoagulation (i.e. atrial fibrillation, mechanical valve, etc.).

- Estimated life expectancy of <3 months.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05683808
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Vermont Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alissa A Thomas, MD
Principal Investigator Affiliation	University of Vermont Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Astrocytoma, Venous Thromboembolism

Additional Details

Patients with primary brain tumors, including glioblastoma and astrocytoma, are at high risk of developing venous thromboemboli (VTE) as a comorbid condition. Prior studies have demonstrated safety and efficacy of primary pharmacological prevention of VTE using blood thinning medications, including apixaban. These studies have included a small cohort of patients with grade 4 glioma. The purpose of this study is to gather additional safety data regarding the use of apixaban for primary prevention of VTE in patients with newly diagnosed grade 4 glioma.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Alissa A Thomas, MD

alissa.thomas@med.uvm.edu

802-847-8400

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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