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    Summary
    EudraCT Number:2012-000797-35
    Sponsor's Protocol Code Number:EC11-287
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-03-06
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000797-35
    A.3Full title of the trial
    Clinical Trial with Cladribine (2-CDA) and Pegylated Interpheron Alfa-2a in patients with advanced systemic mastocytosis carrying D816V KIT mutation (or different mutations involving exon 17 of KIT).
    ENSAYO CLÍNICO EN PACIENTES CON MASTOCITOSIS SISTÉMICA DE MAL PRONÓSTICO CON EL ANÁLOGO DE PURINAS CLADRIBINA (2-CDA) E INTERFERÓN ALFA-2A PEGILADO EN SUJETOS CON MUTACIÓN D816V DE KIT (U OTRAS MUTACIONES EN EL EXÓN 17 DEL KIT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial with Cladribine (2-CDA) and Pegylated Interpheron Alfa-2a in patients with advanced systemic mastocytosis carrying D816V KIT mutation (or different mutations involving exon 17 of KIT).
    ENSAYO CLÍNICO EN PACIENTES CON MASTOCITOSIS SISTÉMICA DE MAL PRONÓSTICO CON EL ANÁLOGO DE PURINAS CLADRIBINA (2-CDA) E INTERFERÓN ALFA-2A PEGILADO EN SUJETOS CON MUTACIÓN D816V DE KIT (U OTRAS MUTACIONES EN EL EXÓN 17 DEL KIT).
    A.3.2Name or abbreviated title of the trial where available
    Cladribine plus Pegylated Interpheron Alfa-2a in systemic mastocytosis.
    Cladribina e Interferón Alfa-2a pegilado en mastocitosis sistémica.
    A.4.1Sponsor's protocol code numberEC11-287
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01602939
    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 SponsorHospital Virgen de la Salud, Toledo (Spain).
    B.1.3.4CountrySpain
    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 supportMinisterio de Sanidad, Servicios Sociales e Igualdad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Virgen de la Salud
    B.5.2Functional name of contact pointCLMast
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Cobisa s/n
    B.5.3.2Town/ cityToledo
    B.5.3.3Post code45071
    B.5.3.4CountrySpain
    B.5.4Telephone number0034925269336
    B.5.5Fax number0034925269355
    B.5.6E-mailivana@sescam.jccm.es
    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 Litak
    D.2.1.1.2Name of the Marketing Authorisation holderLipomed GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNCLADRIBINE
    D.3.9.1CAS number 4291-63-8
    D.3.9.4EV Substance CodeSUB06635MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 2
    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 Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.9.1CAS number 198153-51-4
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number135
    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
    Advanced systemic mastocytosis carrying the D816V KIT mutation (or different exon 17 KIT mutations).
    Mastocitosis sistémica de mal pronóstico con la mutación D816V u otras mutaciones en el exón 17 de KIT.
    E.1.1.1Medical condition in easily understood language
    Advanced systemic mastocytosis carrying the D816V KIT mutation (or different exon 17 KIT mutations).
    Mastocitosis sistémica de mal pronóstico con la mutación D816V u otras mutaciones en el exón 17 de KIT.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To analyze the efficacy and safety of the combined use of cladribine plus peginterpheron alfa-2a in patients with advanced systemic mastocytosis.
    Analizar la eficacia del uso combinado de cladribina y peginterferón alfa-2a en pacientes con mastocitosis sistémica de mal pronóstico.
    E.2.2Secondary objectives of the trial
    To analyze the safety of the combined use of cladribine plus peginterpheron alfa-2a in patients with advanced systemic mastocytosis.
    Analizar la seguridad del uso combinado de cladribina y peginterferón alfa-2a en pacientes con mastocitosis sistémica de mal pronóstico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age older than 18 years.
    Diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or proggressing systemic mastocytosis) with D816V or other exon 17 KIT mutations.
    ECOG ≤ 3.
    Signed informed consent.
    Edad igual o mayor a 18 años.
    Diagnóstico de mastocitosis sistémica de mal pronóstico (mastocitosis sistémica agresiva o en progresión) con la mutación D816V u otras mutaciones en el exón 17 de KIT.
    ECOG ≤ 3.
    Firma del consentimiento informado.
    E.4Principal exclusion criteria
    Impaired liver function (total bilirubin ≥ 2.0 mg/dl, AST or ALT > 3 x upper limit of normal) not related to mastocytosis.
    Impaired renal function (creatinine ≥ 2.0 mg/dL) not related to mastocytosis.
    Grade III-IV cytopenias not related to mastocytosis.
    Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction < 50%).
    Pregnancy or breastfeeding.
    Female patients who do not use contraceptive methods.
    Alteración de la función hepática (bilirrubina total ≥ 2.0 mg/dl, GOT o GPT> 3 veces el límite superior de la normalidad) no relacionada con la mastocitosis.
    Alteración de la función renal (creatinina ≥ 2.0 mg/dL) no relacionada con la mastocitosis.
    Citopenias grado III-IV no relacionadas con la mastocitosis.
    Cardiopatía severa (grado III/IV de la NYHA o fracción de eyección del ventrículo izquierdo < 50%).
    Embarazo o lactancia.
    Mujeres en edad fértil que no usen métodos anticonceptivos fiables.

    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the effect of therapy on bone marrow mast cell infiltration.
    Evaluar el efecto del tratamiento sobre la infiltración mastocitaria en médula ósea.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 and 6 months.
    3 y 6 meses.
    E.5.2Secondary end point(s)
    To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis.
    To evaluate the effect of therapy on mast cell-mediator release symptoms: pruritus, flushing, gastrointestinal symptoms or anaphylaxis).
    To determine the safety of combined therapy with cladribine plus pegylated interpheron alpha-2a.
    To evaluate the effect of therapy on mastocytosis skin lesions.
    To evaluate the effect of therapy on mastocytosis-related organomegalies.
    To evaluate the effect of therapy on mastocytosis-related bone alterations.

    determinar el efecto del tratamiento sobre los niveles de triptasa sérica y otras alteraciones analíticas relacionadas con la mastocitosis.
    Evaluar el efecto del tratamiento sobre los síntomas de liberación de mediadores mastocitarios: picor, flushing, síntomas gastrointestinales o anafilaxia.
    Determinar la seguridad del tratamiento combinado con cladribina y peginterferon alfa-2a.
    Evaluar el efecto del tratamiento sobre las lesiones cutáneas de la mastocitosis.
    Evaluar el efecto del tratamiento sobre las organomegalias relacionadas con la mastocitosis.
    Evaluar el efecto del tratamiento sobre las alteraciones óseas relacionadas con la mastocitosis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months for every endpoint.
    6 meses para cada objetivo.
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Última visita de último sujeto a estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state10
    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)
    None.
    Ninguno.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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