Large-scale Trial Testing the Intensity of CYTOreductive Therapy in Polycythemia Vera (PV)
Status:
Terminated
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Consorzio Mario Negri Sud
Collaborators:
A.O. Ospedale Papa Giovanni XXIII Agenzia Italiana del Farmaco