VTE-POG: Venous Thromboembolism Prevention in Outpatients With Glioma

Sponsor

University of Vermont Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05683808

Collaborator

Dartmouth-Hitchcock Medical Center (Other), MaineHealth (Other)

Enrollment

23.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Astrocytoma Venous Thromboembolism	Drug: Apixaban	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open label study of apixaban for VTE prevention in patients with newly diagnosed grade 4 gliomaOpen label study of apixaban for VTE prevention in patients with newly diagnosed grade 4 glioma

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Venous Thromboembolism Prevention in Outpatients With Glioma

Anticipated Study Start Date :

Jan 16, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

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

Efficacy in prevention of venous thromboembolism [6 months]
Incidence of VTE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.