Clinical trial NCT05683808: Venous Thromboembolism Prevention in Outpatients With Glioma
Official title: Venous Thromboembolism Prevention in Outpatients With Glioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioblastoma
Astrocytoma
Venous Thromboembolism
Keywords: High grade glioma
Glioblastoma
Astrocytoma
Venous thromboembolism
Apixaban
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
name: MaineHealth
First posted: 2023-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label study of apixaban for VTE prevention in patients with newly diagnosed grade 4 glioma
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Safety of apixaban as determined by bleeding risk
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy in prevention of venous thromboembolism
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont Medical Center
name: Alissa A Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: