Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-02-03 @ 8:33 AM
Study NCT ID:
NCT04116502
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2019-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011087', 'term': 'Polycythemia Vera'}], 'ancestors': [{'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}, {'id': 'D006918', 'term': 'Hydroxyurea'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007372', 'term': 'Interferons'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 586}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression of marrow fibrosis', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'Progression of marrow fibrosis (bone marrow collected and analysed at the Weatherall Institute of Molecular Medicine (WIMM) in Oxford'}, {'measure': 'Impact of treatment on molecular signatures of disease', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'Impact of treatment on molecular signatures of disease (as analysed by the WIMM in Oxford)'}, {'measure': 'Clonal involvement', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'within the stem/progenitor cell compartment (as analysed by the WIMM in Oxford)'}, {'measure': 'Clonal evolution', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': '(acquisition of additional mutations, as analysed by the WIMM in Oxford)'}, {'measure': 'Reduction of peripheral blood allele burden', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'of other disease-association mutations (as analysed by the WIMM in Oxford)'}, {'measure': 'Assessment of the prevalence of clonality markers for haematological disease', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'and any change over time (as analysed by the WIMM in Oxford)'}, {'measure': 'Cardiac event', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': '(angina, acute coronary syndrome, acute MI; arrhythmia)'}, {'measure': 'Pulmonary hypertension', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'Pulmonary hypertension as assessed clinically'}, {'measure': 'Coronary intervention', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'e.g. angiogram, angioplasty, CABG'}, {'measure': 'Deterioration in cardiac function', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'e.g. LVEF% on ECHO/MUGA and/or NYHA classification'}, {'measure': 'Cerebrovascular event', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'TIA, haemorrhagic CVA, non-haemorrhagic CVA'}, {'measure': 'Arterial vascular event', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'peripheral vascular disease: claudication, carotid stenosis'}, {'measure': 'Venous thrombosis', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'including DVT, PE, Cerebral, splanchnic, other'}, {'measure': 'Pregnancy loss', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'Pregnancy loss'}, {'measure': 'Thrombosis biomarkers', 'timeFrame': 'Occurring throughout the trial (from randomisation to approximately 3 years post-randomisation)', 'description': 'Correlation of thrombosis biomarkers with clinical thrombosis events'}], 'primaryOutcomes': [{'measure': 'Event Free Survival (EFS)', 'timeFrame': 'the time from randomisation to the date of the first major thrombosis/haemorrhage, death,transformation to Myelodysplastic Syndromes, Acute Myeloid Leukaemia or Post-polycythemia Vera Myelofibrosis, if within the ~3 year trial period', 'description': 'Event Free Survival'}], 'secondaryOutcomes': [{'measure': 'Major thrombosis', 'timeFrame': 'Occurring while on treatment (over 3 years)', 'description': 'As defined in the protocol, combined and split to venous and arterial'}, {'measure': 'Major haemorrhage', 'timeFrame': 'Occurring while on treatment (over 3 years)', 'description': 'As defined in the protocol'}, {'measure': 'Transformation to PPV-MF', 'timeFrame': 'Occurring while on treatment (over 3 years)', 'description': 'Transformation to PPV-MF'}, {'measure': 'Transformation to MDS and/or AML', 'timeFrame': 'Occurring while on treatment (over 3 years)', 'description': 'Transformation to MDS and/or AML'}, {'measure': 'Complete Haematological remission (CHR)', 'timeFrame': '1 year post-treatment', 'description': 'As defined by ELN response criteria at 1 year'}, {'measure': 'Symptom burden/Quality of life (MPN-SAF)', 'timeFrame': 'Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36', 'description': 'As measured via MPN-SAF'}, {'measure': 'Symptom burden/Quality of life (MDASI)', 'timeFrame': 'Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36', 'description': 'As measured via MDASI'}, {'measure': 'Symptom burden/Quality of life (EQ-5D)', 'timeFrame': 'Questionnaires collected at baseline, weeks 12, 26, 39, 55, months 15, 18, 24, 30 and 36', 'description': 'As measured via EQ-5D'}, {'measure': 'Health economics', 'timeFrame': 'At the end of the trial (trial duration of approximately 8 years)', 'description': 'Including cost utility and cost effectiveness analyses as defined by the protocol (e.g. QALYs)'}, {'measure': 'Peripheral blood JAK2 V617F allele burden', 'timeFrame': 'At baseline and annually throughout the trial (from baseline until approximately 3 years post-randomisation)', 'description': 'According to ELN response criteria'}, {'measure': 'Rates of discontinuation', 'timeFrame': 'From treatment prior to protocol defined 3 years', 'description': 'Trial discontinuation'}, {'measure': 'Rate and severity of adverse events', 'timeFrame': 'Continuous throughout the trial (from randomisation until approximately 3 years post-randomisation))', 'description': 'collected according to CTCAE version 4.0 and the MITHRIDATE protocol'}, {'measure': 'Spleen response', 'timeFrame': 'Response at 1 year post randomisation', 'description': 'in patients with splenomegaly'}, {'measure': 'Time free from venesection', 'timeFrame': 'Defined as the mean time between venesections while on trial treatment (treatment duration of 3 years)', 'description': 'Time free from venesection'}, {'measure': 'Secondary malignancy', 'timeFrame': 'Occurring throughout the trial (from randomisation until approximately 3 years post-randomisation)', 'description': 'Malignancy independent to the original diagnosis'}, {'measure': 'Change in QRisk score', 'timeFrame': 'Collected at baseline and years 1, 2 and 3', 'description': 'Change in QRisk score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycythemia Vera']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThere will be no cross-over either between arm A and B or between therapies on Arm B\n\nHC and IFN will be provided as best available therapy, IFN can include standard of pegylated-interferon at Investigators discretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Population:\n\nHigh risk PV defined as WBC \\>11 x 10\\^9/l\\* AND at least ONE of the following\n\n* Age \\>60 years\n* Prior thrombosis or haemorrhage\n* Platelet count \\>1000 x 10\\^9/l\\*\n* Hypertension or diabetes requiring pharmacological therapy (\\*At any time since diagnosis)\n\nInclusion Criteria:\n\n1. Patient ≥18 years of age\n2. Diagnosis of PV meeting the WHO criteria within the past 15 years\n3. Meets criteria of high risk\\* PV (see above for specific population)\n4. Patients must have a screening haemoglobin of \\>8g/dl\n5. Patients may have received antiplatelet agents and venesection\n6. Patients may have received ONE cytoreductive therapy for PV less than 10 years (BUT they should not be resistant or intolerant to that therapy)\n7. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of PV \\> 15 years previously\n2. Absence of JAK-2 mutation\n3. Patients with any contraindications to any of the investigational medical products\n4. Treatment with \\>1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance/intolerance to that therapy\n5. Active infection including Human Immunodeficiency Virus (HIV), hepatitis B, hepatitis C, autoimmune hepatitis, Tuberculosis\n6. Pregnant or lactating patients (Women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry)\n7. Patients with lactose allergies, hypersensitivities, or rare hereditary problems, of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption\n8. Patients with uncontrolled neuropsychiatric disorders\n9. Patients with uncontrolled cutaneous cancers\n10. 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\n11. ECOG Performance Status Score ≥ 3\n12. 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\n13. Patients who have transformed to myelofibrosis\n14. Previous treatment with ruxolitinib\n15. 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\n16. Inadequate liver function as defined by ALT/AST \\>2.0 x ULN\n17. Inadequate renal function as defined by eGFR \\< 30 mls/min\n18. Unable to give informed consent\n\n Additional Exclusion Criteria for France Only\n19. All women of childbearing potential (as per Appendix 8 definition)\n20. No affiliation with the French healthcare system\n21. Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up\n22. Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)\n23. Patients deprived of their liberty by a judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT04116502', 'acronym': 'MITHRIDATE', 'briefTitle': 'MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RG_16-148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A- Ruxolitinib', 'description': 'Treatment with Ruxolitinib', 'interventionNames': ['Drug: Ruxolitinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B- Hydroxycarbamide OR Interferon A', 'description': 'Best Available Therapy (BAT), Treatment with hydroxycarbamide OR Interferon A', 'interventionNames': ['Drug: Hydroxycarbamide', 'Drug: Interferon-Alpha']}], 'interventions': [{'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['Jakavi®'], 'description': '10mg of ruxolitinib twice daily (bd)', 'armGroupLabels': ['A- Ruxolitinib']}, {'name': 'Hydroxycarbamide', 'type': 'DRUG', 'otherNames': ['Hydroxyurea'], 'description': 'Via standard hospital mechanisms', 'armGroupLabels': ['B- Hydroxycarbamide OR Interferon A']}, {'name': 'Interferon-Alpha', 'type': 'DRUG', 'otherNames': ['Interferon, alpha interferon, Intron® A, Roferon® A'], 'description': 'Any formulation, via standard hospital mechanisms', 'armGroupLabels': ['B- Hydroxycarbamide OR Interferon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'BA1 3NG', 'city': 'Bath', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal United Hospital', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Southmead Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 0QQ', 'city': 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'facility': 'University College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RT', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "St George's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Wythenshawe Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CH49 5PE', 'city': 'Metropolitan Borough of Wirral', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Arrowe Park Hospital', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'The James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': 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'lon': -1.40428}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Stoke University Hospital', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'SR4 7TP', 'city': 'Sunderland', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Sunderland Royal Hospital', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'zip': 'B75 7RR', 'city': 'Sutton Coldfield', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Good Hope Hospital', 'geoPoint': {'lat': 52.56667, 'lon': -1.81667}}, {'zip': 'TR1 3LJ', 'city': 'Truro', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'CV34 5BW', 'city': 'Warwick', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Warwick Hospital', 'geoPoint': {'lat': 52.28333, 'lon': -1.58333}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'zip': 'BN11 2DH', 'city': 'Worthing', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Worthing Hospital', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}], 'centralContacts': [{'name': 'Alex Hainsworth', 'role': 'CONTACT', 'email': 'mithridate@trials.bham.ac.uk', 'phone': '+44(0)121 414 2535'}], 'overallOfficials': [{'name': 'Claire Harrison', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Acting on behalf of the Sponsor (UK), Guy's Hospital, London, UK, SE1 9RT"}, {'name': 'Jean-Jacques Kiladjian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '(France) Clinical Investigations Center, Saint-Louis Hospital, Paris, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'MPN Voice', 'class': 'UNKNOWN'}, {'name': 'French National Cancer Institute (Institut National Du Cancer - France)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}