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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2028
  • participants needed
    586
  • sponsor
    University of Birmingham
Updated on 5 December 2021
hydroxyurea
ruxolitinib
interferon

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.

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.

Details
Condition Polycythemia Vera
Treatment Ruxolitinib, Interferon-alpha, Hydroxycarbamide
Clinical Study IdentifierNCT04116502
SponsorUniversity of Birmingham
Last Modified on5 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient 18 years of age
Diagnosis of PV meeting the WHO criteria within the past 10 years
Meets criteria of high risk PV (see above for specific population)
Patients may have received antiplatelet agents and venesection
Patients may have received ONE cytoreductive therapy for PV less than 5 years (BUT they should not be resistant or intolerant to that therapy)
Able to provide written informed consent

Exclusion Criteria

Major thrombosis (both combined and split into venous and arterial)
Major haemorrhage
Transformation to PPV-MF
Transformation to AML and/or MDS
Complete haematological response (CHR) as defined by ELN response criteria at 1 year
Symptom burden/(QALY)quality of life years gained
Health economics including cost utility and cost effectiveness analyses
Peripheral blood JAK2 V617F allele burden according to ELN response criteria
Rates of discontinuation
Adverse events
Spleen response in patients with splenomegaly at Baseline
Time free from venesection
Rate of second malignancies
Change in QRisk score
Unable to give informed consent
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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