Polycythemia VeraNCT05269771
MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera
A study testing Ruxolitinib in people with Polycythemia Vera, run by Novartis Pharmaceuticals at 25 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- Ruxolitinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 25 sitesin 8 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this Treatment Plan have to meet all of the following 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
United Kingdom8 sites
Novartis Investigative Site
Hereford, HR1 2ER
Novartis Investigative Site
Kent, CT9 4AN
Novartis Investigative Site
London, NW3 2PF
Novartis Investigative Site
London, SE5 8AD
Novartis Investigative Site
London, WC1E 6HX
Novartis Investigative Site
Oxford, OX3 7LJ
Novartis Investigative Site
Poole, BH15 2JB
Novartis Investigative Site
Salisbury, SP2 8BJ
Poland7 sites
Novartis Investigative Site
Gdansk, 80-214
Novartis Investigative Site
Katowice, 40-027
Novartis Investigative Site
Krakow, 31-501
Novartis Investigative Site
Wałbrzych, 58-309
Novartis Investigative Site
Warsaw, 00-791
Novartis Investigative Site
Warsaw, 04-141
Novartis Investigative Site
Wroclaw, 50-367
Israel5 sites
Novartis Investigative Site
Kfar Saba, Israel, 44281
Novartis Investigative Site
Kfar Saba, 44281
Novartis Investigative Site
Rehovot, 7610001
Novartis Investigative Site
Tel Aviv, 6423906
Novartis Investigative Site
Tel Giborim Holon, 58100
About this study
Official title: Treatment Plan for Managed Access Program (MAP) to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera (PV)
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.
Read the detailed description
The requesting Treating Physician must submit a request for access to drug (often referred to as Compassionate Use) to Novartis which will review and approve by the medical team experienced with the drug and indication.
- Conditions
- Polycythemia Vera
- Being tested
- Ruxolitinib
- Keywords
- INC424, Ruxolitinib, Jakavi, MAP, Manage access program
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakavi
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269771
- Sponsor's protocol ID
- CINC424B2002I
- Status last verified
- Oct 2025
- First submitted
- 16 Feb 2022
- Last updated
- 5 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Plan for Managed Access Program (MAP) to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera (PV)
- ClinicalTrials.gov ID
- NCT05269771
- Acronym / sponsor ID
- CINC424B2002I
- Conditions
- Polycythemia Vera
- Keywords
- INC424, Ruxolitinib, Jakavi, MAP, Manage access program
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The requesting Treating Physician must submit a request for access to drug (often referred to as Compassionate Use) to Novartis which will review and approve by the medical team experienced with the drug and indication.
Study design
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients eligible for inclusion in this Treatment Plan have to meet all of the following 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: JakaviPatients may self-administer daily ruxolitinib tablets qd or bid orally, without regard to food, in accordance with specified dosing schedule provided by the investigator. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
Related trials for Polycythemia Vera
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RecruitingPhase 2/3
A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025).
Polycythemia Vera
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 2
A Study of Ropeg-Interferon in People With Polycythemia Vera
Polycythemia Vera (PV), JAK2 Mutation
Active, not recruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruxolitinib in people with Polycythemia Vera, run by Novartis Pharmaceuticals at 25 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom, Poland, Israel, Australia, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.