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

• Status: Recruiting
• Trial end date: 2028-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Collaborators: MPN Voice; National Cancer Institute, France; Novartis
• Treatments: Hydroxyurea; Interferon alpha-2; Interferon-alpha; Interferons

Criteria

Population:

High risk PV defined as WBC >11 x 109/l* AND at least ONE of the following

• Age >60 years

• Prior thrombosis or haemorrhage

• Platelet count >1000 x 109/l*

• At any time since diagnosis

Inclusion Criteria:

1. Patient ≥18 years of age

2. Diagnosis of PV meeting the WHO criteria within the past 10 years

3. Meets criteria of high risk* PV (see above for specific population)

4. Patients may have received antiplatelet agents and venesection

5. Patients may have received ONE cytoreductive therapy for PV less than 5 years (BUT they should not be resistant or intolerant to that therapy)

6. Able to provide written informed consent

Exclusion Criteria:

1. Major thrombosis (both combined and split into venous and arterial)

2. Major haemorrhage

3. Transformation to PPV-MF

4. Transformation to AML and/or MDS

5. Complete haematological response (CHR) as defined by ELN response criteria at 1 year

6. Symptom burden/(QALY)quality of life years gained

7. Health economics including cost utility and cost effectiveness analyses

8. Peripheral blood JAK2 V617F allele burden according to ELN response criteria

9. Rates of discontinuation

10. Adverse events

11. Spleen response in patients with splenomegaly at Baseline.

12. Time free from venesection

13. Rate of second malignancies

14. Change in QRisk score

15. Unable to give informed consent