Venous Thromboembolism Prevention in Outpatients With Glioma

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont Medical Center
• Collaborators: Dartmouth-Hitchcock Medical Center; MaineHealth
• Treatments: Apixaban

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.