Large-scale Trial Testing the Intensity of CYTOreductive Therapy in Polycythemia Vera (PV)

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

CYTO-PV is a phase III Prospective, Randomized, Open-label, with Blinded Endpoint evaluation (PROBE), multi-center, clinical trial in patients with diagnosis of Polycythemia vera (PV) treated at the best of recommended therapies (e.g.adequate control of standard cardiovascular risk factors). Irrespective of randomized interventions, all patients will be administered low-dose aspirin (when not contraindicated), i.e.the standard antithrombotic treatment in PV patients.

The purpose of this study to demonstrate that a more intensive cytoreductive therapy, plus low-dose aspirin when not contraindicated, with phlebotomy and/or hydroxyurea (HU), aimed at maintaining hematocrit (HCT) < 45% is more effective than a less intensive cytoreduction (either with phlebotomy or HU plus low-dose aspirin when not contraindicated) maintaining HCT in the range of 45-50% in the reduction of CV deaths plus thrombotic events (stroke, acute coronary syndrome [ACS], transient ischemic attack [TIA], pulmonary embolism [PE], splanchnic thrombosis, deep vein thrombosis [DVT], and any other clinically relevant thrombotic event), in patients with Polycythemia Vera treated at the best of recommended therapies (e.g. adequate control of standard cardiovascular risk factors).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Consorzio Mario Negri Sud
• Collaborators: A.O. Ospedale Papa Giovanni XXIII; Agenzia Italiana del Farmaco
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

Males and females aged 18 years or more are eligible for the study if they meet all the following inclusion criteria:

• New diagnosis of PV according to WHO 2007 diagnostic criteria including Jak 2 V617F mutation status;

• Old diagnosis of PV confirmed with JAK-2 positivity and clinical course of the disease;

• Ability and willingness to comply with all study requirements;

• Written informed consent (obtained before any study specific procedure).

Exclusion Criteria:

• Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception;

• Known hypersensitivity or contraindication to study treatments;

• Significant liver (AST or ALT > 2.5 times ULN) or renal disease (creatinine > 2 mg/ml);

• Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy;

• History of active substance or alcohol abuse within the last year;

• Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol - Baseline and FUP visits schedule and assessments

• Logistic problem related to the patient.