Large-scale Trial Testing the Intensity of CYTOreductive Therapy in Polycythemia Vera (PV)
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).
Timeline
- Start
- 2008-05
- Primary completion
- 2012-06
- Completion
- 2012-07
Outcome
Met primary endpoint
Stopped (Enrollment): “Low accrual rate not allowing planned sample size leads to a futility condition”
paper P=0.007 PMID 23216616 ↗
paper those with a hematocrit target of less than 45% had a significantly lower rate of cardiovascular death and major thrombosis PMID 23216616 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyurea | Other / unclassified | 0.5 g | — |
| Subject | Hydroxyurea | Other / unclassified | 1 g | — |