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

Study acronym: MITHRIDATE
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Primary completion date: Aug 1, 2026 to Oct 31, 2028
    • Study sites: 35 to 47
    • Study completion date: Feb 1, 2028 to Apr 1, 2030
    • Eligibility criteria expanded, about 111 words
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Study sites: 2 to 35
    • Eligibility criteria expanded, about 114 words
    • Secondary endpoints: details revised at 5 of 16 entries
    • Study title revised
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 2019 to Oct 25, 2019
    • Eligibility criteria shortened, about 9 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04116502
Lead Sponsor University of Birmingham
Collaborators: Novartis, MPN Voice, National Cancer Institute, France
Conditions
(from sponsor)		 Polycythemia Vera
Related terms Polycythemia Vera
Enrollment 586 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov