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Venous Thromboembolism Prevention in Outpatients With Glioma (VTE-POG)

Primary Purpose

Glioblastoma, Astrocytoma, Venous Thromboembolism

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apixaban
Sponsored by
University of Vermont Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioblastoma focused on measuring High grade glioma, Glioblastoma, Astrocytoma, Venous thromboembolism, Apixaban

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Efficacy in prevention of venous thromboembolism
    Incidence of VTE

    Full Information

    First Posted
    January 4, 2023
    Last Updated
    January 4, 2023
    Sponsor
    University of Vermont Medical Center
    Collaborators
    Dartmouth-Hitchcock Medical Center, MaineHealth
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05683808
    Brief Title
    Venous Thromboembolism Prevention in Outpatients With Glioma
    Acronym
    VTE-POG
    Official Title
    Venous Thromboembolism Prevention in Outpatients With Glioma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 16, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Vermont Medical Center
    Collaborators
    Dartmouth-Hitchcock Medical Center, MaineHealth

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma, Astrocytoma, Venous Thromboembolism
    Keywords
    High grade glioma, Glioblastoma, Astrocytoma, Venous thromboembolism, Apixaban

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open label study of apixaban for VTE prevention in patients with newly diagnosed grade 4 glioma
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Apixaban
    Intervention Description
    Open label
    Primary Outcome Measure Information:
    Title
    Safety of apixaban as determined by bleeding risk
    Description
    CTCAE 5 reporting of grade 2 non-Central Nervous System (CNS) hemorrhage or grade 2 new CNS hemorrhage.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Efficacy in prevention of venous thromboembolism
    Description
    Incidence of VTE
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alissa A Thomas, MD
    Phone
    802-847-8400
    Email
    alissa.thomas@med.uvm.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Donna Silver
    Phone
    802-656-5040
    Email
    irb@uvm.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alissa A Thomas, MD
    Organizational Affiliation
    University of Vermont Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Venous Thromboembolism Prevention in Outpatients With Glioma

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