NO_LONGER_AVAILABLENot Applicable

MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera

Australia, Belgium, Canada

Plain-language summary

The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with Polycythemia Vera. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Who can participate

Age range12 Years – 99 Years

SexALL

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Inclusion criteria

✓. Male or female aged 12 or over
✓. Confirmed diagnosis of PV based on World Health Organization (WHO) criteria
✓. Patients must have a treatment history for PV that meets the definition of resistance or intolerance to hydroxyurea (HU) or other cytoreductive therapy
✓. Patients with a peripheral blood blast count of 0% at screening
✓. Patients must have recovered or stabilized sufficiently from adverse drug reactions associated with prior treatments before beginning treatment with ruxolitinib
✓. Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 Written patient informed consent must be obtained prior to start of treatment.

Exclusion criteria

✕. History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
✕. Presence of an active uncontrolled infection including significant bacterial, fungal, viral (including CMV, EBV, HHV-6, HBV, HCV, BK or HIV) or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. Patients with inactive chronic infection (without viral replication) can be enrolled.
✕. History of progressive multifocal leuko-encephalopathy (PML).
✕. Presence of severely impaired renal function defined by serum creatinine \> 2 mg/dL (\>176.8 μmol/L), or have estimated creatinine clearance \< 30 ml/min measured or calculated by Cockroft Gault equation.
✕. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are
✕. Pregnancy
✕. Not able to understand and to comply with treatment instructions and requirements

Trial details

NCT IDNCT05269771

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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