MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera (MITHRIDATE)
A Phase III, Randomised, Open-label, Multicenter International Trial Comparing Ruxolitinib With Either HydRoxycarbamIDe or Interferon Alpha as First Line ThErapy for High Risk Polycythemia Vera
Sponsor: French National Cancer Institute (Institut National Du Cancer - France)
A observational or N/A phase clinical study on Polycythemia Vera, this trial is actively recruiting participants. The trial is conducted by French National Cancer Institute (Institut National Du Cancer - France) and has accumulated 11 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
11 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
-
Sep 2025 — May 2026 [monthly]
Recruiting PHASE3
-
Dec 2024 — Sep 2025 [monthly]
Recruiting PHASE3
-
Sep 2024 — Dec 2024 [monthly]
Recruiting PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
▶ Show 6 earlier versions
-
Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE3
-
Jan 2023 — Jun 2024 [monthly]
Recruiting PHASE3
-
Dec 2021 — Jan 2023 [monthly]
Recruiting PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Recruiting PHASE3
-
Apr 2020 — Jan 2021 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
-
Nov 2019 — Apr 2020 [monthly]
Not Yet Recruiting PHASE3
First recorded
Oct 2019
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- French National Cancer Institute (Institut National Du Cancer - France)
- MPN Voice
- Novartis
- University of Birmingham
For direct contact, visit the study record on ClinicalTrials.gov .