Actively Recruiting
MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera
Led by University of Birmingham · Updated on 2026-04-28
586
Participants Needed
47
Research Sites
544 weeks
Total Duration
On this page
Sponsors
U
University of Birmingham
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of polycythemia vera meeting WHO criteria within the past 15 years
- High-risk polycythemia vera defined by WBC >11 x 10^9/l and at least one of: age >60 years, prior thrombosis or hemorrhage, platelet count >1000 x 10^9/l, or hypertension/diabetes requiring medication
- Screening hemoglobin greater than 8 g/dl
- Prior use of antiplatelet agents and venesection allowed
- Up to one prior cytoreductive therapy for polycythemia vera within 10 years, without resistance or intolerance
- Ability to provide written informed consent
You will not qualify if you...
- Diagnosis of polycythemia vera more than 15 years ago
- Absence of JAK-2 mutation
- Contraindications to any study medications
- Treatment with more than one cytoreductive therapy, treatment duration over 10 years, or resistance/intolerance to therapy
- Active infections including HIV, hepatitis B or C, autoimmune hepatitis, or tuberculosis
- Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test before trial entry
- Lactose intolerance or related hereditary conditions
- Uncontrolled neuropsychiatric disorders
- Uncontrolled skin cancers
- Patients and partners unwilling to use effective contraception during treatment and for 6 months after
- ECOG performance status score of 3 or higher
- Unstable or significant cardiac conditions including recent myocardial infarction
- Disease transformation to myelofibrosis
- Previous treatment with ruxolitinib
- Recent or current low platelet or neutrophil counts not due to therapy
- Inadequate liver or kidney function as defined by laboratory tests
- Inability to give informed consent
- Additional exclusions for France: women of childbearing potential, lack of French healthcare affiliation, psychiatric care limiting consent ability, legal protection status, or judicial/administrative deprivation of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
2
Royal United Hospital
Bath, United Kingdom, BA1 3NG
Actively Recruiting
3
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
4
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
5
Blackpool Victoria Hospital
Blackpool, United Kingdom, FY3 8NR
Actively Recruiting
6
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Actively Recruiting
7
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
8
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
9
Kent and Canterbury Hospital
Canterbury, United Kingdom, CT1 3NG
Actively Recruiting
10
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
11
St Richard's Hospital
Chichester, United Kingdom, PO19 6SE
Actively Recruiting
12
Colchester Hospital
Colchester, United Kingdom, CO4 5JL
Actively Recruiting
13
Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
14
Russells Hall Hospital
Dudley, United Kingdom, DY1 2HQ
Actively Recruiting
15
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
16
Royal Devon and Exeter Hospital
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
17
Gloucestershire Royal Hospital
Gloucester, United Kingdom, GL1 3NN
Actively Recruiting
18
Calderdale Royal Hospital
Halifax, United Kingdom, HX3 0PW
Active, Not Recruiting
19
Huddersfield Royal Infirmary
Huddersfield, United Kingdom, HD3 3EA
Active, Not Recruiting
20
Raigmore Hospital
Inverness, United Kingdom, IV2 3UJ
Actively Recruiting
21
Kettering General Hospital
Kettering, United Kingdom, NN16 8UZ
Actively Recruiting
22
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
23
St John's Hospital
Livingston, United Kingdom, EH54 6PP
Actively Recruiting
24
University College Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
25
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
26
St George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
27
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Actively Recruiting
28
Arrowe Park Hospital
Metropolitan Borough of Wirral, United Kingdom, CH49 5PE
Actively Recruiting
29
The James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Actively Recruiting
30
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
31
Royal Gwent Hospital
Newport, United Kingdom, NP20 2UB
Actively Recruiting
32
North Tyneside General Hospital
North Shields, United Kingdom, NE29 8NH
Actively Recruiting
33
Northampton General Hospital
Northampton, United Kingdom, NN1 5BD
Actively Recruiting
34
Norfolk and Norwich University Hospital
Norwich, United Kingdom, NR4 7UY
Actively Recruiting
35
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
36
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
37
Royal Berkshire Hospital
Reading, United Kingdom, RG1 5AN
Actively Recruiting
38
Halton Hospital
Runcorn, United Kingdom, WA7 2DA
Actively Recruiting
39
Wexham Park Hospital
Slough, United Kingdom, SL2 4HL
Actively Recruiting
40
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
41
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
42
Sunderland Royal Hospital
Sunderland, United Kingdom, SR4 7TP
Actively Recruiting
43
Good Hope Hospital
Sutton Coldfield, United Kingdom, B75 7RR
Actively Recruiting
44
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LJ
Actively Recruiting
45
Warwick Hospital
Warwick, United Kingdom, CV34 5BW
Actively Recruiting
46
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
47
Worthing Hospital
Worthing, United Kingdom, BN11 2DH
Actively Recruiting
Research Team
A
Alex Hainsworth
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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