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    Summary
    EudraCT Number:2010-019500-23
    Sponsor's Protocol Code Number:MPD-RC111
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-01-31
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-019500-23
    A.3Full title of the trial
    Single Arm Salvage Therapy with Pegylated Interferon Alfa-2a for Patients with High Risk Polycythemia Vera or High Risk Essential Thrombocythemia who are Either Hydroxyurea Resistant or Intolerant Or have had Abdominal Vein Thrombosis.
    Terapia di salvataggio a singolo braccio con l'interferone Alfa-2a (PEGASYS) Peghilato per i pazienti con Policitemia Vera ad alto rischio o Trombocitemia Essenziale ad alto rischio che sono resistenti o intolleranti alla Hydroxyurea o che hanno avuto una trombosi della vena spalcnica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapy with Pegylated Interferon Alfa-2a for Patients with Polycythemia Vera or Essential Thrombocythemia who are Either Hydroxyurea Resistant or Intolerant Or have had Abdominal Vein Thrombosis.
    Terapia con l'interferone Alfa-2a (PEGASYS) Peghilato per i pazienti con Policitemia Vera o Trombocitemia Essenziale che sono resistenti o intolleranti al trattamento con Hydroxyurea o che hanno avuto una trombosi della vena spalcnica.
    A.3.2Name or abbreviated title of the trial where available
    SINGLE ARM PEGASYS TRIAL
    SINGLE ARM PEGASYS TRIAL
    A.4.1Sponsor's protocol code numberMPD-RC111
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01259817
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCONSORZIO MARIO NEGRI SUD
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMyeloproliferative Disorders-Research Consortium
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCONSORZIO MARIO NEGRI SUD
    B.5.2Functional name of contact pointLaboratory of Clinical Epidemiology
    B.5.3 Address:
    B.5.3.1Street Addressvia Nazionale 8/A
    B.5.3.2Town/ citySanta Maria Imbaro (Chieti)
    B.5.3.3Post code66030
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0872 570252
    B.5.5Fax number+39 0872 570206
    B.5.6E-mailmpdrc@negrisud.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Peginterferon PFS
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Basel
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2A
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High risk polycythemia vera and high risk essential thrombocythemia
    Policitemia Vera (PV) ad alto rischio o Trombocitemia Essenziale (ET) ad alto rischio
    E.1.1.1Medical condition in easily understood language
    polycythemia vera or essential thrombocythemia
    Policitemia Vera o Tromcitemia Essenziale
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10036057
    E.1.2Term Polycythaemia vera
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10015493
    E.1.2Term Essential thrombocythaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the ability of Pegylated Interferon Alfa-2a to achieve Complete Response or Partial Response (By LeukemiaNet Criteria) in three strata of patients with (1) high risk polycythemia vera or (2) high risk essential thrombocythemia or (3) splanchic vein thrombosis
    Valutare la capacità dell'interferone Alfa-2a Peghilato di far raggiungere la risposta completa o la risposta parziale (dai criteri di LeukemiaNet) in tre strati di pazienti con (1) policitemia vera ad alto rischi e trombocitemia essenziale ad alto rischio o (3) trombosi della vena splancnica.
    E.2.2Secondary objectives of the trial
    -To evaluate the toxicity and tolerability of therapy Pegylated Interferon Alfa-2a in each of the 3 strata. -To measure the impact of Pegylated Interferon Alfa-2a on key biomarkers of the disease. -To evaluate specific pre-defined toxicity and tolerance of Pegylated Interferon Alfa-2a through a sequential structured symptom assessment package of patient reported outcome instruments. -To estimate survival, and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after Pegylated Interferon Alfa-2a. -To estimate the observed incidence of major cardiovascular events (defined as cardiovascular death, myocardial
    -tossicità e tollerabilità della terapia dell’interferone Alfa2a -l'impatto della terapia con l’interferone Alfa2a peghilato sui biomarkers chiave della patologia -Valutare specifiche pre-definite tossicità e tolleranza alla terapia con l’interferone Alfa2a peghilato attraverso l’accertamento sequenziale di una serie di sintomi costitutivi del paziente indicativi dell’esito. -la sopravvivenza e l'incidenza dello sviluppo della sindrome mielodisplastica, mielofibrosi o trasformazione in leucemia in seguito alla terapia con l’interferone Alfa2a peghilato. -l'incidenza dei maggiori eventi cardiovascolari in seguito alla terapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria (ALL of): Male or female subjects aged 18 years or older are eligible if they meet the following inclusion criteria. -High risk PV or High risk ET diagnosed according to modified World Health Organization criteria -EITHER Intolerant or resistant to Hydroxyurea by established criteria OR suffered an Splanchnic Vein Thrombosis -Able and willing to comply with study criteria -Signed and informed consent to participant in this study -Willing to participate in associated biomarker study Specific to Splanchnic Vein Thrombosis Inclusion criteria: -SVT in chronic phase (at least 3 months after the occurrence of thrombosis) -Treated with oral anticoagulants but no aspirin -Liver enzymes not > 2 times the upper limits of normal -Absence of encephalopathy, refractory or infected ascites, esophageal or gastric varices of grade > 1 at time of trial entry -Bone marrow biopsy confirmed diagnosis of PV or ET -Ferritin measurement as assessment of iron stores and corrected where possible -Red cell mass measurement (after iron deficiency correction if required)
    Criteri di Inclusione Policitemia Vera ad alto rischio (tutti): Soggetti di sesso maschile o femminili dai 18 anni sono eleggibili se rispondono ai seguenti criteri dell'inclusione. • PV ad alto rischio o ET ad alto rischio diagnosticato secondo i criteri modificati dell'organizzazione mondiale della sanità • Sia intollerantI o resistentI alla Hydroxyurea secondo i criteri stabiliti oppure colore che sono affetti da una trombosi della vena spalcnica. • la possibilità e la volontà di aderire alle procedure dei criteri del protocollo • Consenso informato per iscritto • la volontà di Voler partecipare allo studio collegato dei biomarker Criteri di esclusione (uno dei seguenti) • Qualunque controindicazione al trattamento con interferone Alfa-2 peghilato e non peghilato • Presenza di fattori di comorbidità che mettono a rischio la vita del paziente • Storia di abuso di alcool o droghe nell’ultimo anno • Donne incinte, che allattano o potenzialmente in gravidanza, non protette da quest’ultima mediante metodo di contraccezione accettato • Storia di malattie psichiatriche (es. depressione) • Storia di malattie autoimmunutarie (es. epatite) • Ipersensibilità al INF-a • Positività all’HIV-HBV o altre infezioni sistemiche • Evidenze di grave retinopatia (es. retinite da CMV. Degenerazione della macula) o disordini oftalmologici clinicamente rilevanti (es. dovuti a diabete mellito o ipertensione) • Storia o altre evidenze di patologia epatica scompensata • Trombosi venosa splancnica (incluse sindrome di Budd-Chiari, vena portale, trombosi splenica o mesenterica) • Storia o altre evidenze di malattia cronica polmonare associata a limitazioni funzionali • Disfunzioni tiroidee non adeguatamente controllate • Trattamenti con farmaci sperimentali meno di 6 settimane prima dall’assunzione della prima dose di farmaco • Neutrofili &lt; 1,5x10(9)/L • Mutazione nell’esone 12 del gene JAK2 • Pazienti che non possiedono i criteri di diagnosi di PV o ET-MF (vedi appendice B) • Nessuna precedente esposizione all’interferone peghilato • Soggetti con altre condizioni mediche che secondo l’opinione del medico potrebbero compromettere i risultati dello studio per effetti deleteri del trattamento Criteri aggiuntivi obbligatori d’esclusione \inclusione per i pazienti con trombosi della vena splacnica Criteri d’inclusione • SVT in fase cronica(almeno 3 mesi dall’insorgenza di trombosi) • Trattamento con anticoagulanti eccetto l’Aspirina • Enzimi epatici NON &gt; 2 volte il limite superiore dei valori normali. • Assenza di encefalopatia, ascite refrattaria o infettiva , esofagite varicosa di grado &gt; 1 all’inclusione • PV e ET confermate da biopsia del midollo osseo • Misura della ferritina come stima del quantitativo di ferro e corretto dove possibile. • Misura della massa dei globuli rossi (correggendo per la mancanza di ferro se richiesto).
    E.4Principal exclusion criteria
    Exclusion Criteria (ANY of): -Presence of any life-threatening co-morbidity -History of active substance or alcohol abuse within the last year -Any contraindications to pegylated or non-pegylated interferon -Subjects who have a positive pregnancy test, are pregnant, lactating or of reproductive potential and not practicing an effective means of contraception -History of psychiatric disorder (e.g. depression; suicidal ideation; psychosis) -History of autoimmune disorder (e.g. hepatitis; ITP; scleroderma; severe psoriasis affecting > 10% of the body, rheumatoid arthritis requiring more than intermittent NSAID for management) -Hypersensitivity to IFN-α -HIV, HCV, HBV, or systemic infection -Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension) -History or other evidence of decompensated liver disease -History or other evidence of chronic pulmonary disease associated with functional limitation -Thyroid dysfunction not adequately controlled -Any investigational drug <6 weeks prior to the first dose of study drug -Presence of JAK2 exon 12 mutation -Patients should not meet criteria for post PV or post ET-MF (see appendix B) -No previous exposure to any formulation of interferon -Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment.
    Criteri esclusione • Storia del trapianto principale dell’organo • Storia di malattia severa non controllata Questi pazienti possono avere un conteggio dei globuli normali all'inizio per nei pazienti con trombosi della vena splacnica e senza PV o ET, l’iperattività splenica induce leucopenia, anemia e trombopenia evidenti. In pazienti che hanno MPD, la conta dei globuli periferici sono “anomalmente normali, perciò questo significa che possono avere i leucociti, l'emoglobina e le piastrine nei range usuali pertanto non richiedere mai terapie citoriduttive per raggiungere i valori sopra citati.
    E.5 End points
    E.5.1Primary end point(s)
    Complete Response. Criteria for complete response in ET: -Platelet count </= 400 x 109/L AND -No disease-related symptoms* AND -Normal spleen size on imaging AND -WBC </= 10 x 109/L Criteria for complete response in PV: -Hematocrit <0.45 without phlebotomy AND -Platelet count < 400 x 109/L AND -WBC > 10 x 109/L AND -Normal spleen size on imaging AND -No disease related symptoms Criteria for complete response in patients with splanchnic vein thrombosis: -Hematocrit <0.42 without phlebotomy AND -Platelet count 100-200 x 109/L AND -WBC 2-8 x 109/L AND -No spleen enlargement from enrollment baseline AND -No disease related symptoms
    Risposta Completa clinico-ematologica. Nella Trombocitemia Essenziale la risposta completa (RC) viene definita da un numero di piastrine inferiore o uguale a 400 x 109/L, da assenza di sintomi relati alla malattia, da assenza di splenomegalia e da un numero di globuli bianchi inferiore o uguale a 10 x 109/L. Nella Policitemia Vera la risposta completa è definita da un ematocrito inferiore al 45% (senza flebotomia), da un numero di piastrine inferiore o uguale a 400 x 109/L, un numero di globuli bianchi inferiore o uguale a 10 x 109/L, da assenza di splenomegalia e da assenza di sintomi relati alla malattia Nei pazienti con Trombosi Venosa Splancnica la risposta completa è definita da un ematocrito inferiore al 42% (senza flebotomia), da un numero di piastrine all'incirca pari a 100-200 x 109/L, un numero di globuli bianchi all'incirca pari a 2-8 x 10(9)/L e da assenza di sintomi relati alla malattia
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    -To evaluate the toxicity and tolerability of therapy Pegylated Interferon Alfa-2a in the study populations. -To evaluate specific pre-defined toxicity and tolerance of Pegylated Interferon Alfa-2a through a sequential structured symptom assessment package of patient reported outcome instruments. -Estimate survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after Pegylated Interferon Alfa-2a. Estimate incidence of major cardiovascular events (defined as cardiovascular death, myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, Budd Chiari syndrome, deep vein thrombosis, and any other clinically relevant thrombotic event) after therapy Pegylated Interferon Alfa-2a. -To measure the impact of Pegylated Interferon Alfa-2a to impact key biomarkers of the disease (s) – JAK2V617F, hematopoietic cell clonality in platelets and granulocytes in females, bone marrow histopathology, and cytogenetic abnormalities
    • Valutare la tossicità e la tollerabilità della terapia dell’interferone Alfa2a peghilato nei tre strati. • Misurare l'impatto della terapia con l’interferone Alfa2a peghilato sui biomarkers chiave della patologia - JAK2V617F includendo la quantificazione delle mutazioni a carico degli alleli JAk e cMPL, la clonalità delle cellule ematopoietiche nelle piastrine e nei granulociti nelle donne, istopatologia del midollo osseo e anomalie citogenetiche. • Valutare specifiche pre-definite tossicità e tolleranza alla terapia con l’interferone Alfa2a peghilato attraverso l’accertamento sequenziale di una serie di sintomi costitutivi del paziente indicativi dell’esito. • Misurare la sopravvivenza e l'incidenza dello sviluppo della sindrome mielodisplastica, mielofibrosi o trasformazione in leucemia in seguito alla terapia con l’interferone Alfa2a peghilato. • Misurare l'incidenza dei maggiori eventi cardiovascolari (definiti come morte cardiovascoalre, infarto del miocardio, ictus, attacco ischemico transitorio, embolia polmonare, sindrome di Budd Chiari, trombosi venosa profonda e ogni altro evento trombotico clinicamente rilevante) in seguito alla terapia con l’interferone Alfa2a Peghilato.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 188
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NA
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Myeloproliferative Didorders Research Consortium(MPD-RC)
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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