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New hope for High-Risk blood cancer patients: ruxolitinib trial launches

NCT ID NCT04116502

Disease control Sponsor: University of Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether ruxolitinib works better than current standard therapies (hydroxycarbamide or interferon alpha) for people with high-risk polycythemia vera, a blood cancer that increases red blood cells. About 586 adults aged 18 and older with high-risk features will be randomly assigned to receive ruxolitinib or the doctor's choice of standard treatment. The main goal is to see which approach better prevents serious events like blood clots, bleeding, or disease progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 586 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Population: High risk PV defined as WBC \>11 x 10\^9/l\* AND at least ONE of the following * Age \>60 years * Prior thrombosis or haemorrhage * Platelet count \>1000 x 10\^9/l\* * Hypertension or diabetes requiring pharmacological therapy (\*At any time since diagnosis) Inclusion Criteria: 1. Patient ≥18 years of age 2. Diagnosis of PV meeting the WHO criteria within the past 15 years 3. Meets criteria of high risk\* PV (see above for specific population) 4. Patients must have a screening haemoglobin of \>8g/dl 5. Patients may have received antiplatelet agents and venesection 6. Patients may have received ONE cytoreductive therapy for PV less than 10 years (BUT they should not be resistant or intolerant to that therapy) 7. Able to provide written informed consent Exclusion Criteria: 1. Diagnosis of PV \> 15 years previously 2. Absence of JAK-2 mutation 3. Patients with any contraindications to any of the investigational medical products 4. Treatment with \>1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance/intolerance to that therapy 5. Active infection including Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, autoimmune hepatitis, Tuberculosis 6. Pregnant or lactating patients (Women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry) 7. Patients with lactose allergies, hypersensitivities, or rare hereditary problems, of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption 8. Patients with uncontrolled neuropsychiatric disorders 9. Patients with uncontrolled cutaneous cancers 10. Patients and partners not prepared to adopt highly effective contraception measures (if sexually active) whilst on treatment and for at least 6 months after completion of study medication 11. ECOG Performance Status Score ≥ 3 12. Uncontrolled rapid or paroxysmal atrial fibrillation, uncontrolled or unstable angina, recent (within the last 6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease \> NYHA ( New York Heart Association) Class II 13. Patients who have transformed to myelofibrosis 14. Previous treatment with ruxolitinib 15. Previous (within the last 12 months) or current platelet count \<100 x 109/L or neutrophil count \< 1 x 109/L not due to therapy 16. Inadequate liver function as defined by ALT/AST \>2.0 x ULN 17. Inadequate renal function as defined by eGFR \< 30 mls/min 18. Unable to give informed consent Additional Exclusion Criteria for France Only 19. All women of childbearing potential (as per Appendix 8 definition) 20. No affiliation with the French healthcare system 21. Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up 22. Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice) 23. Patients deprived of their liberty by a judicial or administrative decision

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polycythemia vera

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    RECRUITING

    Aberdeen, AB25 2ZN, United Kingdom

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Arrowe Park Hospital

    RECRUITING

    Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

  • Belfast City Hospital

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Birmingham Heartlands Hospital

    RECRUITING

    Birmingham, B9 5SS, United Kingdom

  • Blackpool Victoria Hospital

    RECRUITING

    Blackpool, FY3 8NR, United Kingdom

  • Calderdale Royal Hospital

    ACTIVE_NOT_RECRUITING

    Halifax, HX3 0PW, United Kingdom

  • Castle Hill Hospital

    RECRUITING

    Cottingham, HU16 5JQ, United Kingdom

  • Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Colchester Hospital

    RECRUITING

    Colchester, CO4 5JL, United Kingdom

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Gloucestershire Royal Hospital

    RECRUITING

    Gloucester, GL1 3NN, United Kingdom

  • Good Hope Hospital

    RECRUITING

    Sutton Coldfield, B75 7RR, United Kingdom

  • Guy's Hospital

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Halton Hospital

    RECRUITING

    Runcorn, WA7 2DA, United Kingdom

  • Huddersfield Royal Infirmary

    ACTIVE_NOT_RECRUITING

    Huddersfield, HD3 3EA, United Kingdom

  • Kent and Canterbury Hospital

    RECRUITING

    Canterbury, CT1 3NG, United Kingdom

  • Kettering General Hospital

    RECRUITING

    Kettering, NN16 8UZ, United Kingdom

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • New Cross Hospital

    RECRUITING

    Wolverhampton, WV10 0QP, United Kingdom

  • Norfolk and Norwich University Hospital

    RECRUITING

    Norwich, NR4 7UY, United Kingdom

  • North Tyneside General Hospital

    RECRUITING

    North Shields, NE29 8NH, United Kingdom

  • Northampton General Hospital

    RECRUITING

    Northampton, NN1 5BD, United Kingdom

  • Nottingham City Hospital

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Raigmore Hospital

    RECRUITING

    Inverness, IV2 3UJ, United Kingdom

  • Royal Berkshire Hospital

    RECRUITING

    Reading, RG1 5AN, United Kingdom

  • Royal Bournemouth Hospital

    RECRUITING

    Bournemouth, BH7 7DW, United Kingdom

  • Royal Cornwall Hospital

    RECRUITING

    Truro, TR1 3LJ, United Kingdom

  • Royal Devon and Exeter Hospital

    RECRUITING

    Exeter, EX2 5DW, United Kingdom

  • Royal Gwent Hospital

    RECRUITING

    Newport, NP20 2UB, United Kingdom

  • Royal Stoke University Hospital

    RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • Royal United Hospital

    RECRUITING

    Bath, BA1 3NG, United Kingdom

  • Russells Hall Hospital

    RECRUITING

    Dudley, DY1 2HQ, United Kingdom

  • Southampton General Hospital

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • Southmead Hospital

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • St George's Hospital

    RECRUITING

    London, SW17 0QT, United Kingdom

  • St John's Hospital

    RECRUITING

    Livingston, EH54 6PP, United Kingdom

  • St Richard's Hospital

    RECRUITING

    Chichester, PO19 6SE, United Kingdom

  • Sunderland Royal Hospital

    RECRUITING

    Sunderland, SR4 7TP, United Kingdom

  • The James Cook University Hospital

    RECRUITING

    Middlesbrough, TS4 3BW, United Kingdom

  • University College Hospital

    RECRUITING

    London, NW1 2BU, United Kingdom

  • University Hospital of Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Warwick Hospital

    RECRUITING

    Warwick, CV34 5BW, United Kingdom

  • Western General Hospital

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Wexham Park Hospital

    RECRUITING

    Slough, SL2 4HL, United Kingdom

  • Worthing Hospital

    RECRUITING

    Worthing, BN11 2DH, United Kingdom

  • Wythenshawe Hospital

    RECRUITING

    Manchester, M23 9LT, United Kingdom

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