BridgeMD
A phase III, randomised, open-label, Multicenter International Trial comparing ruxolitinib with either HydRoxycarbamIDe or interferon Alpha as first line ThErapy for high risk polycythemia vera
EU CTIS ID: 2024-516109-21-00
What this study is testing
To compare the time to combined incidence of; major thrombosis, major haemorrhage, death, transformation to Myelodysplastic syndrome, Acute Myeloid Leukaemia, or post-PV (PPV) Myelofibrosis in high risk PV patients randomised to ruxolitinib versus best available therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patient ≥ 18 years of age
- 2. Diagnosis of PV meeting WHO criteria within past 15 years
- 3. Meets criteria of high risk PV (High risk PV defined as WBC >11 x 109/l* AND at least ONE of the following • Age >60 years • Prior thrombosis or major haemorrhage related to disease • Platelet count >1000 x 109/l* • Hypertension or diabetes requiring pharmacological therapy. *At any time since diagnosis)
- 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 or less cytoreductive therapy for less than 10 years (BUT they should not be resistant or intolerant to that therapy)
You likely can't join if
- 1. Diagnosis of PV > 15 years previously
- 18. Unable to give informed consent
- 2. Absence of any 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
See the full eligibility criteria
- 1. Patient ≥ 18 years of age
- 2. Diagnosis of PV meeting WHO criteria within past 15 years
- 3. Meets criteria of high risk PV (High risk PV defined as WBC >11 x 109/l* AND at least ONE of the following • Age >60 years • Prior thrombosis or major haemorrhage related to disease • Platelet count >1000 x 109/l* • Hypertension or diabetes requiring pharmacological therapy. *At any time since diagnosis)
- 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 or less cytoreductive therapy for less than 10 years (BUT they should not be resistant or intolerant to that therapy)
- 7. Able to provide written informed consent
- 1. Diagnosis of PV > 15 years previously
- 18. Unable to give informed consent
- 2. Absence of any 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 galactose intolerance, total lactase deficiency or glucose- galactose malabsorption
- 8. Patients with uncontrolled neuropsychiatric disorders
- 9. Patients with uncontrolled cutaneous cancers
- 19. All women of childbearing potential (as per Appendix 8 definition) FRANCE ONLY
- 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
- 20. No affiliation with the French healthcare system FRANCE ONLY
- 21. Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up FRANCE ONLY
- 23. Patients deprived of their liberty by a judicial or administrative decision FRANCE ONLY
- 22. Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice) FRANCE ONLY
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.