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

ConditionPolycythemia Vera

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Birmingham

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age >60 years

Prior thrombosis or haemorrhage

Platelet count >1000 x 10^9/l*

Hypertension or diabetes requiring pharmacological therapy (*At any time since diagnosis)

Disqualifiers

Diagnosis of PV > 15 years previously

Absence of JAK-2 mutation

Patients with any contraindications to any of the investigational medical products

Treatment with >1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance/intolerance to that therapy

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

586 Participants

are divided into 2 treatment groups

Group A: A- RuxolitinibExperimental treatment 1 intervention

Group B: B- Hydroxycarbamide OR Interferon AActive comparator 2 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Time frame

Occurring while on treatment (over 3 years)

Transformation to MDS and/or AML

Time frame

Occurring while on treatment (over 3 years)

Other outcomes

Progression of marrow fibrosis

Progression of marrow fibrosis (bone marrow collected and analysed at the Weatherall Institute of Molecular Medicine (WIMM) in Oxford

Time frame

Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)

Impact of treatment on molecular signatures of disease

Impact of treatment on molecular signatures of disease (as analysed by the WIMM in Oxford)

Time frame

Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)

Clonal involvement

within the stem/progenitor cell compartment (as analysed by the WIMM in Oxford)

Time frame

Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)

Clonal evolution

(acquisition of additional mutations, as analysed by the WIMM in Oxford)

Time frame

Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)

Locations47

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Sponsors and contacts

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University of Birmingham

Lead sponsor

Novartis

Collaborator

MPN Voice

Collaborator

National Cancer Institute, France

Collaborator

Source ClinicalTrials.gov

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