Therapy with Pegylated Interferon Alfa-2a for Patients with Polycythemia Vera or Essential Thrombocythemia who are Either Hydroxyurea Resistant or Intolerant Or have had Abdominal Vein Thrombosis.

• Conditions: High risk polycythemia vera and high risk essential thrombocythemia; MedDRA 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: EUCTR2010-019500-23-IT
• Lead Sponsor: CONSORZIO MARIO NEGRI SUD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-31
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

Inclusion Criteria (ALL of): Male or female subjects aged 18 years or older are eligible if they meet the following inclusion criteria. -High risk PV or High risk ET diagnosed according to modified World Health Organization criteria -EITHER Intolerant or resistant to Hydroxyurea by established criteria OR suffered an Splanchnic Vein Thrombosis -Able and willing to comply with study criteria -Signed and informed consent to participant in this study -Willing to participate in associated biomarker study Specific to Splanchnic Vein Thrombosis -SVT in chronic phase (at least 3 months after the occurrence of thrombosis) -Treated with oral anticoagulants but no aspirin -Liver enzymes not > 2 times the upper limits of normal -Absence of encephalopathy, refractory or infected ascites, esophageal or gastric varices of grade > 1 at time of trial entry -Bone marrow biopsy confirmed diagnosis of PV or ET -Ferritin measurement as assessment of iron stores and corrected where possible -Red cell mass measurement (after iron deficiency correction if required)
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Exclusion Criteria (ANY of): -Presence of any life-threatening co-morbidity -History of active substance or alcohol abuse within the last year -Any contraindications to pegylated or non-pegylated interferon -Subjects who have a positive pregnancy test, are pregnant, lactating or of reproductive potential and not practicing an effective means of contraception -History of psychiatric disorder (e.g. depression; suicidal ideation; psychosis) -History of autoimmune disorder (e.g. hepatitis; ITP; scleroderma; severe psoriasis affecting > 10% of the body, rheumatoid arthritis requiring more than intermittent NSAID for management) -Hypersensitivity to IFN-a -HIV, HCV, 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 -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 -Presence of 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 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