Venous Thromboembolism Prevention in Outpatients With Glioma

Phase 2

Not yet recruiting

• Conditions: Astrocytoma; Glioblastoma; Venous Thromboembolism

• Registration Number: NCT05683808
• Lead Sponsor: University of Vermont Medical Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Last Update Submitted: 2023-01-04
• Study First Posted: 2023-01-13
• Last Update Posted: 2023-01-13
• Study Start: 2023-01-16
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of apixaban as determined by bleeding risk	6 months	CTCAE 5 reporting of grade 2 non-Central Nervous System (CNS) hemorrhage or grade 2 new CNS hemorrhage.

Secondary Outcome Measures

Name	Time	Method
Efficacy in prevention of venous thromboembolism	6 months	Incidence of VTE