NCT04116502

MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera

A Phase III, Randomised, Open-label, Multicenter International Trial Comparing Ruxolitinib With Either HydRoxycarbamIDe or Interferon Alpha as First Line ThErapy for High Risk Polycythemia Vera

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 586 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.

Detailed description

The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation. There will be no cross-over either between arm A and B or between therapies on Arm B HC and IFN will be provided as best available therapy, IFN can include standard of pegylated-interferon at Investigators discretion.

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	Ruxolitinib	10mg of ruxolitinib twice daily (bd)
DRUG	Hydroxycarbamide	Via standard hospital mechanisms
DRUG	Interferon-Alpha	Any formulation, via standard hospital mechanisms

Timeline

• Start date: 2019-10-25
• Primary completion: 2028-10-31
• Completion: 2030-04-01
• First posted: 2019-10-04
• Last updated: 2024-11-18

Locations

47 sites across 1 country: United Kingdom