Venous Thromboembolism Prevention in Outpatients With Glioma

Trial Title: Venous Thromboembolism Prevention in Outpatients With Glioma

NCT ID: NCT05683808

Condition: Glioblastoma
Astrocytoma
Venous Thromboembolism

Conditions: Official terms:
Glioblastoma
Glioma
Astrocytoma
Thromboembolism
Venous Thromboembolism
Apixaban

Conditions: Keywords:
High grade glioma
Glioblastoma
Astrocytoma
Venous thromboembolism
Apixaban

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

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 glioma

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Apixaban
Description: Open label

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.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: January 16, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: University of Vermont Medical Center
Agency class: Other

Collaborator:
Agency: Dartmouth-Hitchcock Medical Center
Agency class: Other

Collaborator:
Agency: MaineHealth
Agency class: Other

Source: University of Vermont Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05683808