Randomized Trial of Pegylated Interferon Alfa-2a versus Hydroxyurea Therapy in the Treatment of High Risk Polycythemia Vera and High Risk Essential Thrombocythemia - PEGHU-Phase3

CONSORZIO MARIO NEGRI SUD0 个研究点目标入组 612 人开始时间: 2012年1月31日最近更新: 2014年2月3日

适应症

试验速览

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•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.

发起方

CONSORZIO MARIO NEGRI SUD