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

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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:
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. Diagnosis of PV > 10 years previously. 2. Absence of any JAK-2 mutation. 3. Patients with any contraindications to any of the investigational medical products. 4. Treatment with >1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 5 years OR resistance/intolerance to that therapy. 5. Active infection including hepatitis B, hepatitis C, Tuberculosis. 6. Pregnant or lactating patients (Women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry) 7. 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. 8. ECOG Performance Status Score ≥ 3. 9. 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. 10.

Patients who have transformed to myelofibrosis. 11. Previous treatment with ruxolitinib. 12. 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. 13. Inadequate liver function as defined by ALT/AST > 2.0 x ULN. 14. Inadequate renal function as defined by eGFR < 30 ml/min. 15. Unable to give informed consent

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04116502
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Birmingham
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Claire HarrisonJean-Jacques Kiladjian
Principal Investigator Affiliation	Acting on behalf of the Sponsor (UK), Guy's Hospital, London, UK, SE1 9RT(France) Clinical Investigations Center, Saint-Louis Hospital, Paris, France
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Polycythemia Vera

Additional Details

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.

Arms & Interventions

Arms

Experimental: A- Ruxolitinib

Treatment with Ruxolitinib

Active Comparator: B- Hydroxycarbamide OR Interferon A

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

Interventions

Drug: - Ruxolitinib

10mg of ruxolitinib twice daily (bd)

Drug: - Hydroxycarbamide

Via standard hospital mechanisms

Drug: - Interferon-Alpha

Any formulation, via standard hospital mechanisms

Contact a Trial Team

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International Sites

Aberdeen Royal Infirmary, Aberdeen, United Kingdom

Status

Recruiting

Address

Aberdeen Royal Infirmary

Aberdeen, , AB25 2ZN

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