Comparing Ruxolitinib to Hydroxycarbamide or Interferon for High Risk Polycythemia Vera

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III, randomized-controlled trial aims to evaluate the efficacy of ruxolitinib compared to best available therapy, which includes hydroxycarbamide or interferon alpha, in patients with high-risk polycythemia vera. Participants will be randomly assigned to receive either ruxolitinib or the chosen best available therapy, with no cross-over allowed between treatment arms. The trial will be conducted across multiple international centers, ensuring a diverse patient population. The primary goal is to determine which treatment provides better outcomes for patients at high risk of complications from their condition.

Why it matters

Who can join: the full rules

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

Where it's running

• Aberdeen Royal Infirmary
  Aberdeen, United Kingdom Recruiting
• Royal United Hospital
  Bath, United Kingdom Recruiting
• Belfast City Hospital
  Belfast, United Kingdom Recruiting
• Birmingham Heartlands Hospital
  Birmingham, United Kingdom Recruiting
• Blackpool Victoria Hospital
  Blackpool, United Kingdom Recruiting
• Glan Clwyd Hospital
  Bodelwyddan, United Kingdom Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Claire Harrison — Acting on behalf of the Sponsor (UK), Guy's Hospital, London, UK, SE1 9RT
• Study coordinator: Natalia Morelli
• Email: mithridate@trials.bham.ac.uk
• Phone: +44(0)121 414 2535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study is testing if combining two medications, pegylated interferon α-2b and ruxolitinib, can help people with polycythemia vera who haven't responded well to other treatments feel better.

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• Using Ruxolitinib to treat symptoms of essential thrombocythemia and polycythemia vera

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• DMR-001 in CALR-mutant myeloproliferative neoplasms

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.