Ruxolitinib versus hydroxycarbamide or interferon as first-line therapy in high-risk polcythemia vera
- Conditions
- Polycythaemia veraCancer
- Registration Number
- ISRCTN12885480
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 586
Current participant inclusion criteria as of 09/05/2023:
1. Patient 18 years of age or over
2. Diagnosis of PV meeting WHO criteria within past 10 years
3. Meets criteria of high-risk PV, defined as WBC >11 x 10(9)/l AND at least ONE of the following:
3.1. Aged >60 years
3.2. Prior thrombosis or major haemorrhage related to disease
3.3. Platelet count >1000 x 10(9)/l at any time after diagnosis
3.4. Diagnosed <10 years
3.5. Received treatment for <5 years
4. Patients may have received antiplatelet agents and venesection
5. Patients may have received ONE or less cytoreductive therapy for less than 5 years (BUT they should not be resistant or intolerant to that
therapy)
6. Able to provide written informed consent
_____
Previous participant inclusion criteria:
1. Patient 18 years of age or over
2. Diagnosis of PV meeting WHO criteria within past 10 years
3. Meets criteria of high risk* PV, defined as WBC > 11 x 109/l* AND at least ONE of the following:
3.1. Age > 60 years
3.2. Prior thrombosis or major haemorrhage related to disease
3.3. Platelet count > 1000 x 109/l*
3.4. Diagnosed < 10 years
3.5. Received treatment for < 5 years)
4. Patients may have received antiplatelet agents and venesection
5. Patients may have received ONE or less cytoreductive therapy for less than 5 years (BUT they should not be resistant or intolerant to that
therapy)
6. Able to provide written informed consent
1. Diagnosis of PV >10 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 5 years OR resistance/intolerance to that therapy
5. Active infection including hepatitis B, hepatitis C, 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 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 medication
8. ECOG Performance Status Score =3
9. 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
10. Patients who have transformed to myelofibrosis
11. Previous treatment with ruxolitinib
12. 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 therapy
13. Inadequate liver function as defined by ALT/AST >2.0 x ULN
14. Inadequate renal function as defined by eGFR < 30 ml/min
15. Unable to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method