Access to Ruxolitinib for Patients with Polycythemia Vera

Sponsor: Novartis Pharmaceuticals

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05269771

Provider View

This program provides access to the medication ruxolitinib for patients with Polycythemia Vera, a type of blood cancer. Doctors will follow specific treatment guidelines and local health regulations.

Patient Parameters

Program Overview

The goal of this program is to allow patients with Polycythemia Vera (PV) to access the drug ruxolitinib. This is especially for those who have not responded well to other treatments. Doctors need to request access to the drug from Novartis, which will review the request to ensure it is appropriate for the patient.

Description

Doctors can request access to ruxolitinib for their patients with Polycythemia Vera through a process called Compassionate Use. This means the drug is provided to patients who need it but cannot get it through regular channels. The request is reviewed by a medical team experienced with the drug to ensure it is suitable for the patient.

Eligibility Criteria

Inclusion Criteria

  • Must be 12 years or older.
  • Have a confirmed diagnosis of Polycythemia Vera (PV) based on specific medical criteria.
  • Have tried other treatments for PV but did not respond well or could not tolerate them.
  • Have no immature white blood cells (blasts) in the blood at the time of screening.
  • Must have recovered from any side effects of previous treatments before starting ruxolitinib.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must provide written informed consent before starting treatment.

Exclusion Criteria

  • Have a known allergy to ruxolitinib or similar drugs.
  • Have an active, uncontrolled infection that requires treatment.
  • Have a history of a specific brain infection called progressive multifocal leukoencephalopathy (PML).
  • Have severe kidney problems, indicated by certain blood test results.
  • Women who can become pregnant must use effective birth control during treatment and for 30 days after stopping treatment, unless they meet specific criteria that make pregnancy impossible.
  • Cannot be pregnant.
  • Must be able to understand and follow treatment instructions.

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