Trial | NCT04116502  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    586
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.
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.
Study Started
Oct 25
2019
Primary Completion
Aug 01
2026
Anticipated
Study Completion
Feb 01
2028
Anticipated
Last Update
Dec 09
2022

Drug Ruxolitinib

10mg of ruxolitinib twice daily (bd)

  • Other names: Jakavi®

Drug Hydroxycarbamide

Via standard hospital mechanisms

  • Other names: Hydroxyurea

Drug Interferon-Alpha

Any formulation, via standard hospital mechanisms

  • Other names: Interferon, alpha interferon, Intron® A, Roferon® A

A- Ruxolitinib Experimental

Treatment with Ruxolitinib

B- Hydroxycarbamide OR Interferon A Active Comparator

Best Available Therapy (BAT), Treatment with hydroxycarbamide OR Interferon A

Criteria 

Population:

High risk PV defined as WBC >11 x 10^9/l* AND at least ONE of the following

Age >60 years
Prior thrombosis or haemorrhage
Platelet count >1000 x 10^9/l* (*At any time since diagnosis)

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:

Diagnosis of PV > 10 years previously
Absence of any 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 5 years OR resistance/intolerance to that therapy
Active infection including hepatitis B, hepatitis C, Tuberculosis
Pregnant or lactating patients (Women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry)
Patients and partners of childbearing potential not prepared to adopt highly effective contraception measures (if sexually active) whilst on treatment and for at least 6 months after completion of study medication
ECOG Performance Status Score ≥ 3
Uncontrolled rapid or paroxysmal atrial fibrillation, uncontrolled or unstable angina, recent (6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease > NYHA (New York Heart Association) Class II
Patients who have transformed to myelofibrosis
Previous treatment with ruxolitinib
Previous (within the last 12 months) or current platelet count <100 x 109/L or neutrophil count < 1 x 109/L not due to therapy
Inadequate liver function as defined by ALT/AST > 2.0 x ULN
Inadequate renal function as defined by eGFR < 30 ml/min
Unable to give informed consent
No Results Posted