Trial to compare the responses in two strata of patients with (1) high risk polycythemia vera or (2) high risk essential thrombocythemia. Each patient will receive PEGASYS (Pegylated Interferon Alfa-2a) or Hydroxyurea (also known as Hydroxycarbamide). The treatment assigned will be chosen by chance.
- Conditions
- High Risk Polycythemia Vera or High Risk Essential ThrombocythemiaMedDRA version: 14.1Level: PTClassification code 10036057Term: Polycythaemia veraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10015493Term: Essential thrombocythaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2010-019501-41-IT
- Lead Sponsor
- CONSORZIO MARIO NEGRI SUD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 612
Inclusion Criteria: High risk PV ANY ONE of the following: Age >60 years Previous documented thrombosis, erythromelalgia or migraine either after diagnosis or within 10 years before diagnosis and considered to be disease related Significant (i.e. > 5cm below costal margin on palpation) or symptomatic (pain, early satiety) splenomegaly Platelets > 1000 x 109/L Diabetes or hypertension requiring pharmacological therapy High risk ET ANY ONE of the following factors: Age > 60 years Platelet count > 1500 x 109/L Previous thrombosis Previous hemorrhage related to ET Diabetes or hypertension requiring pharmacological therapy Other Inclusion criteria Diagnosed less than 3 years prior to entry on trial Never treated with cytoreductive drugs except hydroxyurea for up to 3 months maximum (phlebotomy, aspirin allowed) Age: > 18 years (no upper limit) Ability and willingness to comply with all study requirements Signed informed consent to participate in this study. Willing to participate in associated correlative science biomarker study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 408
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 204
(ANY of) Any contraindications to pegylated interferon or hydroxyurea Presence of any life-threatening co-morbidity History of active substance or alcohol abuse within the last year Subjects who are pregnant, lactating or of reproductive potential and not practicing an effective means of contraception History of psychiatric disorder (e.g. depression) History of autoimmune disorder (e.g. hepatitis) Hypersensitivity to IFN-a HIV, HBV, or systemic infection Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension) History or other evidence of decompensated liver disease Splanchnic vein thrombosis (includes Budd-Chiari, portal vein, splenic and mesenteric thrombosis) History or other evidence of chronic pulmonary disease associated with functional limitation Thyroid dysfunction not adequately controlled Any investigational drug <6 weeks prior to the first dose of study drug Neutrophil count <1.5 x 109/L JAK2 exon 12 mutation Patients should not meet criteria for post PV or post ET-MF (see appendix B) No previous exposure to any formulation of pegylated interferon Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method