We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Polycythaemia vera
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current participant exclusion criteria as of 06/06/2025:1. Diagnosis of PV > 15 years previously2. Absence of JAK-2 mutation3. Patients with any contraindications to any of the investigational medical products4. Treatment with >1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance/intolerance to that therapy5. Active infection including Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, autoimmune hepatitis, tuberculosis6. 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 malabsorption8. Patients with uncontrolled neuropsychiatric disorders9. Patients with uncontrolled cutaneous cancers10. 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 medication11. ECOG Performance Status Score ≥ 312. 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 II13. Patients who have transformed to myelofibrosis14. Previous treatment with ruxolitinib15. Previous (within the last 12 months) or current platelet count <100 x 109/L or neutrophil count < 1 x 109/L not due to therapy16. Inadequate liver function as defined by ALT/AST >2.0 x ULN17. Inadequate renal function as defined by eGFR < 30 mls/min18. 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 system21. Persons under psychiatric care who would impede understanding of informed consent and optimal treatment and follow-up22. 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_____
Previous participant inclusion criteria:1. Diagnosis of PV >10 years previously2. Absence of JAK-2 mutation3. Patients with any contraindications to any of the investigational medical products4. Treatment with >1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 5 years OR resistance/intolerance to that therapy5. Active infection including hepatitis B, hepatitis C, Tuberculosis6. 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 and partners of childbearing potential not prepared to adopt highly effective contraception measures (if sexually active) whilst on treatment and for at least 6 months after completion of study medication8. ECOG Performance Status Score ≥39. 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 II10. Patients who have transformed to myelofibrosis11. Previous treatment with ruxolitinib12. Previous (within the last 12 months) or current platelet count <100 x 109/L or neutrophil count < 1 x 10(9)/L not due to therapy13. Inadequate liver function as defined by ALT/AST >2.0 x ULN14. Inadequate renal function as defined by eGFR < 30 ml/min15. Unable to give informed consent
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Prof
Claire
Harrison
+44 (0)207 188 2742
Claire.Harrison@gstt.nhs.uk
The study is sponsored by University of Birmingham and funded by Novartis; MPN Voice.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS: 39201
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
