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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
586
10mg of ruxolitinib twice daily (bd)
Via standard hospital mechanisms
Any formulation, via standard hospital mechanisms
Event Free Survival (EFS)
Event Free Survival
Time frame: the time from randomisation to the date of the first major thrombosis/haemorrhage, death,transformation to Myelodysplastic Syndromes, Acute Myeloid Leukaemia or Post-polycythemia Vera Myelofibrosis, if within the ~3 year trial period
Major thrombosis
As defined in the protocol, combined and split to venous and arterial
Time frame: Occurring while on treatment (over 3 years)
Major haemorrhage
As defined in the protocol
Time frame: Occurring while on treatment (over 3 years)
Transformation to PPV-MF
Transformation to PPV-MF
Time frame: Occurring while on treatment (over 3 years)
Transformation to MDS and/or AML
Transformation to MDS and/or AML
Time frame: Occurring while on treatment (over 3 years)
Complete Haematological remission (CHR)
As defined by ELN response criteria at 1 year
Time frame: 1 year post-treatment
Symptom burden/Quality of life (MPN-SAF)
As measured via MPN-SAF
Time frame: Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36
Symptom burden/Quality of life (MDASI)
As measured via MDASI
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Aberdeen Royal Infirmary
Aberdeen, United Kingdom
RECRUITINGRoyal United Hospital
Bath, United Kingdom
RECRUITINGBelfast City Hospital
Belfast, United Kingdom
RECRUITINGBirmingham Heartlands Hospital
Birmingham, United Kingdom
RECRUITINGBlackpool Victoria Hospital
Blackpool, United Kingdom
RECRUITINGRoyal Bournemouth Hospital
Bournemouth, United Kingdom
RECRUITINGSouthmead Hospital
Bristol, United Kingdom
RECRUITINGAddenbrooke's Hospital
Cambridge, United Kingdom
RECRUITINGKent and Canterbury Hospital
Canterbury, United Kingdom
RECRUITINGUniversity Hospital of Wales
Cardiff, United Kingdom
RECRUITING...and 37 more locations
Time frame: Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36
Symptom burden/Quality of life (EQ-5D)
As measured via EQ-5D
Time frame: Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36
Health economics
Including cost utility and cost effectiveness analyses as defined by the protocol (e.g. QALYs)
Time frame: At the end of the trial (trial duration of approximately 8 years)
Peripheral blood JAK2 V617F allele burden
According to ELN response criteria
Time frame: At baseline and annually throughout the trial (from baseline until approximately 3 years post-randomisation)
Rates of discontinuation
Trial discontinuation
Time frame: From treatment prior to protocol defined 3 years
Rate and severity of adverse events
collected according to CTCAE version 4.0 and the MITHRIDATE protocol
Time frame: Continuous throughout the trial (from randomisation until approximately 3 years post-randomisation))
Spleen response
in patients with splenomegaly
Time frame: Response at 1 year post randomisation
Time free from venesection
Time free from venesection
Time frame: Defined as the mean time between venesections while on trial treatment (treatment duration of 3 years)
Secondary malignancy
Malignancy independent to the original diagnosis
Time frame: Occurring throughout the trial (from randomisation until approximately 3 years post-randomisation)
Change in QRisk score
Change in QRisk score
Time frame: Collected at baseline and years 1, 2 and 3