Venous Thromboembolism Prevention in Outpatients With Glioma

Glioblastoma Clinical Trial

— VTE-POG  

Official title:

Venous Thromboembolism Prevention in Outpatients With Glioma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05683808
• Other study ID #: NNECOS004
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: University of Vermont Medical Center
• Contact: Alissa A Thomas, MD
• Phone: 802-847-8400
• Email: alissa.thomas[@]med.uvm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioma
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Apixaban
Open label

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont Medical Center	Dartmouth-Hitchcock Medical Center, MaineHealth

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of apixaban as determined by bleeding risk	CTCAE 5 reporting of grade 2 non-Central Nervous System (CNS) hemorrhage or grade 2 new CNS hemorrhage.	6 months
Secondary	Efficacy in prevention of venous thromboembolism	Incidence of VTE	6 months