Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

RECRUITING

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

Lead Sponsor:

University of Birmingham

Collaborating Sponsors:

Novartis

MPN Voice

Conditions:

Polycythemia Vera

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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\*
  • Hypertension or diabetes requiring pharmacological therapy (\*At any time since diagnosis)
  • Patient ≥18 years of age
  • Diagnosis of PV meeting the WHO criteria within the past 15 years
  • Meets criteria of high risk\* PV (see above for specific population)
  • Patients must have a screening haemoglobin of \>8g/dl
  • Patients may have received antiplatelet agents and venesection
  • Patients may have received ONE cytoreductive therapy for PV less than 10 years (BUT they should not be resistant or intolerant to that therapy)
  • Able to provide written informed consent

Exclusion

  • Diagnosis of PV \> 15 years previously
  • Absence of 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 10 years OR resistance/intolerance to that therapy
  • Active infection including Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, autoimmune hepatitis, 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 with lactose allergies, hypersensitivities, or rare hereditary problems, of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption
  • Patients with uncontrolled neuropsychiatric disorders
  • Patients with uncontrolled cutaneous cancers
  • Patients and partners 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 (within the last 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 mls/min
  • Unable to give informed consent
  • Additional Exclusion Criteria for France Only
  • All women of childbearing potential (as per Appendix 8 definition)
  • No affiliation with the French healthcare system
  • Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up
  • Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)
  • Patients deprived of their liberty by a judicial or administrative decision

Key Trial Info

Start Date :

October 25 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2030

Estimated Enrollment :

586 Patients enrolled

Trial Details

Trial ID

NCT04116502

Start Date

October 25 2019

End Date

April 1 2030

Last Update

November 18 2024

Active Locations (47)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 12 (47 locations)

1

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

2

Royal United Hospital

Bath, United Kingdom, BA1 3NG

3

Belfast City Hospital

Belfast, United Kingdom, BT9 7AB

4

Birmingham Heartlands Hospital

Birmingham, United Kingdom, B9 5SS