Venous Thromboembolism Prevention in Outpatients With Glioma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vermont Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Apixaban

    Drug

    Open label

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Single arm studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

Efficacy in prevention of venous thromboembolism

Incidence of VTE

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Vermont Medical Center

Lead sponsor

Dartmouth-Hitchcock Medical Center

Collaborator

MaineHealth

Collaborator