Preventing blood clots in outpatients with newly diagnosed grade 4 glioma using apixaban

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 2 trial gives apixaban to adults with newly diagnosed WHO grade 4 glioma to prevent venous thromboembolism. Eligible patients with adequate platelets, kidney function, and planned radiation/chemotherapy are enrolled and receive apixaban with regular clinical and imaging follow-up. The study primarily collects safety data on intracranial and other bleeding risks in this high-risk population while recording VTE incidence. Results will help determine whether routine prophylactic anticoagulation is appropriate for patients with grade 4 glioma.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Vermont Medical Center
  Burlington, Vermont, United States Recruiting

Study contacts

• Principal investigator: Alissa A Thomas, MD — University of Vermont Medical Center
• Study coordinator: Alissa A Thomas, MD
• Email: alissa.thomas@med.uvm.edu
• Phone: 802-847-8400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FT536 injection for recurrent WHO Grade 4 astrocytoma

  This will try a single intratumoral dose of FT536, an off-the-shelf engineered NK‑cell therapy, in adults undergoing repeat surgery for recurrent Grade 4 astrocytoma.

  Recruiting Phase 1 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT07560865

• Pre-radiation chemotherapy for high-grade glioma

  Researchers are testing whether giving temozolomide before radiation can help patients with newly diagnosed high-grade gliomas see better outcomes and clearer MRI results after treatment.

  Recruiting Phase 2 Cooper Norcross Health · Camden, New Jersey · NCT07439172

• Understanding brain blood flow and metabolism in patients with brain lesions

  This study is trying to understand how blood flow and metabolism in the brain are affected in patients with brain tumors like glioblastoma, glioma, and astrocytoma.

  Recruiting Erasme University Hospital · Brussels · NCT06797661

• Combining eflornithine and temozolomide for newly diagnosed glioblastoma

  This study is testing a new combination of two medications, eflornithine and temozolomide, to find the best dose for people with newly diagnosed glioblastoma.

  Recruiting at 7 sites Phase 1 Orbus Therapeutics, Inc. · Birmingham, Alabama and 7 other locations · NCT05879367

• Gene therapy combined with radiotherapy for brain tumors

  This study is testing a new gene therapy combined with targeted radiation to see if it can safely help people with recurrent high-grade brain tumors.

  Recruiting Phase 1 Henry Ford Health System · Detroit, Michigan · NCT05686798

• Implantable microdevice to test drug effects in primary brain tumors

  A tiny implantable device is placed into your glioma during surgery to see if local releases of standard glioma drugs cause tumor responses.

  Recruiting Early Phase 1 Brigham and Women's Hospital · Boston, Massachusetts · NCT04135807

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.