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

Sponsor
University of Birmingham
Study ID
NCT04116502
Phase
PHASE3
Status
Recruiting
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Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 25, 2019
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Apr 1, 2030

Study Design

Enrollment
586 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A- Ruxolitinib
    Treatment with Ruxolitinib
  • Active Comparator: B- Hydroxycarbamide OR Interferon A
    Best Available Therapy (BAT), Treatment with hydroxycarbamide OR Interferon A

Primary Outcome Measure

Event Free Survival (EFS) [ 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 ]

Central Contacts

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