MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera
Treatment Plan for Managed Access Program (MAP) to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera (PV)
1 other identifier
expanded_access
N/A
8 countries
25
Brief 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.
Trial Health
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25 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 8, 2022
CompletedNovember 5, 2025
October 1, 2025
February 16, 2022
October 31, 2025
Conditions
Keywords
Interventions
Patients may self-administer daily ruxolitinib tablets qd or bid orally, without regard to food, in accordance with specified dosing schedule provided by the investigator.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients eligible for this Treatment Plan must not meet any of the following 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
- women whose sexual orientation precludes intercourse with a male partner.
- women whose partners have been sterilized by vasectomy or other means.
- using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable throughout the period of treatment and 30 days after treatment discontinuation.
- Any female aged 8 years and above is to be treated as a woman of child-bearing potential.
- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL \[for US only: and estradiol \< 20 pg/mL\] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Pregnancy
- Not able to understand and to comply with treatment instructions and requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Novartis Investigative Site
Orange, New South Wales, 2800, Australia
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Calgary, Alberta, T2N 2T9, Canada
Novartis Investigative Site
Tehran, 11367, Iran
Novartis Investigative Site
Kfar Saba, Israel, 44281, Israel
Novartis Investigative Site
Kfar Saba, 44281, Israel
Novartis Investigative Site
Rehovot, 7610001, Israel
Novartis Investigative Site
Tel Aviv, 6423906, Israel
Novartis Investigative Site
Tel Giborim Holon, 58100, Israel
Novartis Investigative Site
Groningen, 9700RB, Netherlands
Novartis Investigative Site
Gdansk, 80-214, Poland
Novartis Investigative Site
Katowice, 40-027, Poland
Novartis Investigative Site
Krakow, 31-501, Poland
Novartis Investigative Site
Warsaw, 00-791, Poland
Novartis Investigative Site
Warsaw, 04-141, Poland
Novartis Investigative Site
Wałbrzych, 58-309, Poland
Novartis Investigative Site
Wroclaw, 50-367, Poland
Novartis Investigative Site
Hereford, HR1 2ER, United Kingdom
Novartis Investigative Site
Kent, CT9 4AN, United Kingdom
Novartis Investigative Site
London, NW3 2PF, United Kingdom
Novartis Investigative Site
London, SE5 8AD, United Kingdom
Novartis Investigative Site
London, WC1E 6HX, United Kingdom
Novartis Investigative Site
Oxford, OX3 7LJ, United Kingdom
Novartis Investigative Site
Poole, BH15 2JB, United Kingdom
Novartis Investigative Site
Salisbury, SP2 8BJ, United Kingdom