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Compares treatment options for Polycythemia Vera
Official title MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera
ClinicalTrials.gov ID: NCT04116502
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for polycythemia vera.
Also referred to as Jakavi®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
See the full eligibility 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\
- 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
- 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 \>...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aberdeen, United Kingdom
- Bath, United Kingdom
- Belfast, United Kingdom
- Birmingham, United Kingdom
- Blackpool, United Kingdom
- Bournemouth, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Canterbury, United Kingdom
- Cardiff, United Kingdom
- Chichester, United Kingdom
- Colchester, United Kingdom
- Cottingham, United Kingdom
- Dudley, United Kingdom
- Edinburgh, United Kingdom
- Exeter, United Kingdom
- Gloucester, United Kingdom
- Halifax, United Kingdom
- Huddersfield, United Kingdom
- Inverness, United Kingdom
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aberdeen, United Kingdom; Bath, United Kingdom; Belfast, United Kingdom; Birmingham, United Kingdom; Blackpool, United Kingdom; Bournemouth, United Kingdom and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.