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
Who is this study for? Patients with high risk polycythemia vera
Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient ≥18 years of age
• Diagnosis of PV meeting the WHO criteria within the past 15 years
• Meets criteria of high risk\* PV (see above for specific population)
• Patients must have a screening haemoglobin of \>8g/dl
• Patients may have received antiplatelet agents and venesection
• Patients may have received ONE cytoreductive therapy for PV less than 10 years (BUT they should not be resistant or intolerant to that therapy)
• Able to provide written informed consent
Locations
Other Locations
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Royal United Hospital
RECRUITING
Bath
Belfast City Hospital
RECRUITING
Belfast
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Blackpool Victoria Hospital
RECRUITING
Blackpool
Royal Bournemouth Hospital
RECRUITING
Bournemouth
Southmead Hospital
RECRUITING
Bristol
Addenbrooke's Hospital
RECRUITING
Cambridge
Kent and Canterbury Hospital
RECRUITING
Canterbury
University Hospital of Wales
RECRUITING
Cardiff
St Richard's Hospital
RECRUITING
Chichester
Colchester Hospital
RECRUITING
Colchester
Castle Hill Hospital
RECRUITING
Cottingham
Russells Hall Hospital
RECRUITING
Dudley
Western General Hospital
RECRUITING
Edinburgh
Royal Devon and Exeter Hospital
RECRUITING
Exeter
Gloucestershire Royal Hospital
RECRUITING
Gloucester
Calderdale Royal Hospital
ACTIVE_NOT_RECRUITING
Halifax
Huddersfield Royal Infirmary
ACTIVE_NOT_RECRUITING
Huddersfield
Raigmore Hospital
RECRUITING
Inverness
Kettering General Hospital
RECRUITING
Kettering
Leicester Royal Infirmary
RECRUITING
Leicester
St John's Hospital
RECRUITING
Livingston
Guy's Hospital
RECRUITING
London
St George's Hospital
RECRUITING
London
University College Hospital
RECRUITING
London
Wythenshawe Hospital
RECRUITING
Manchester
Arrowe Park Hospital
RECRUITING
Metropolitan Borough Of Wirral
The James Cook University Hospital
RECRUITING
Middlesbrough
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Royal Gwent Hospital
RECRUITING
Newport
North Tyneside General Hospital
RECRUITING
North Shields
Northampton General Hospital
RECRUITING
Northampton
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Nottingham City Hospital
RECRUITING
Nottingham
Churchill Hospital
RECRUITING
Oxford
Royal Berkshire Hospital
RECRUITING
Reading
Halton Hospital
RECRUITING
Runcorn
Wexham Park Hospital
RECRUITING
Slough
Southampton General Hospital
RECRUITING
Southampton
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
Sunderland Royal Hospital
RECRUITING
Sunderland
Good Hope Hospital
RECRUITING
Sutton Coldfield
Royal Cornwall Hospital
RECRUITING
Truro
Warwick Hospital
RECRUITING
Warwick
New Cross Hospital
RECRUITING
Wolverhampton
Worthing Hospital
RECRUITING
Worthing
Contact Information
Primary
Alex Hainsworth
mithridate@trials.bham.ac.uk
+44(0)121 414 2535
Time Frame
Start Date:2019-10-25
Estimated Completion Date:2030-04-01
Participants
Target number of participants:586
Treatments
Experimental: A- Ruxolitinib
Treatment with Ruxolitinib
Active_comparator: B- Hydroxycarbamide OR Interferon A
Best Available Therapy (BAT), Treatment with hydroxycarbamide OR Interferon A