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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41039   clinical trials with a EudraCT protocol, of which   6717   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2006-002987-24
    Sponsor's Protocol Code Number:152CL201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-09
    Trial results View 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 number2006-002987-24
    A.3Full title of the trial
    Estudio de fase 2 multicéntrico, abierto, randomizado, para evaluar la seguridad y la eficacia de lumiliximab en combinación con fludarabina, ciclofosfamida y rituximab, comparado con fludarabina, ciclofosfamida y rituximab solo, en sujetos con leucemia linfoide crónica recurrente

    A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia
    A.3.2Name or abbreviated title of the trial where available
    Lumiliximab en combinación FCR en el tratamiento de LLC recurrente
    A.4.1Sponsor's protocol code number152CL201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiogen Idec Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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.3.1Product nameLumiliximab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLumiliximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Leucemia linfoide crónica recurrente

    Relapsed Chronic Lymphocytic Leukemia (CLL)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10008956
    E.1.2Term Chronic lymphatic leukaemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es determinar la eficacia de lumiliximab cuando se administra en combinación con el régimen de fludarabina, ciclofosfamida y rituximab (FCR), comparado con FCR solo, para el tratamiento de sujetos con LLC recurrente.
    E.2.2Secondary objectives of the trial
    El objetivo secundario de este estudio es evaluar y comparar el perfil de seguridad de los sujetos con LLC recurrente tratados con lumiliximab en combinación con FCR, comparado con FCR solo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Otorgar el consentimiento informado por escrito y firmado, aprobado por el Comité Ético
    - Presentar LLC de células B CD23+ y CD20+ recurrente, diagnosticada de acuerdo con los criterios del NCI-WG.
    - Los sujetos no deben haber recibido previamente más de dos regímenes de tratamiento con agente único o de combinación para la progresión de la enfermedad.
    - Enfermedad en estadio III o IV de Rai (correspondiente al estadio C de Binet) o en estadio I o II de Rai (estadio A o B de Binet) si se determina que hay progresión de la enfermedad, que se evidenciará por una duplicación rápida del recuento de linfocitos periféricos, linfadenopatía progresiva, esplenomegalia progresiva o síntomas B (versión modificada de la clasificación del estadio clínico de Rai).
    - Estado funcional OMS menor o igual a 2.
    - Edad igual o superior a 18 años.
    - Los sujetos, tanto varones como mujeres, que sean potencialmente fértiles deben comprometerse a utilizar métodos anticonceptivos aceptables durante el tratamiento y hasta 12 meses después de terminar el tratamiento.
    - Función hepática adecuada:
    - Bilirrubina menor o igual a 2,0 mg/dl (26 µmol/l).
    - AST y ALT menor o igual a 2 veces el límite superior de normalidad.
    - Estado hematológico adecuado:
    - Recuento de plaquetas mayor o igual a 109/l sin ayuda de transfusiones.
    - Recuento absoluto de neutrófilos RAN mayor o igual a 1 x 109/l.
    - Función renal adecuada:
    - Aclaramiento de creatinina, calculado de acuerdo con la fórmula de Cockroft y Gault, >50 ml/min.
    - Creatinina sérica menor o igual a 1,5 veces el límite superior de normalidad.
    E.4Principal exclusion criteria
    - Sujetos que sean refractarios a fludarabina y rituximab (FR),fludarabina y ciclofosfamida (FC) o FCR. Se considera que un sujeto es refractario al tratamiento si no alcanza, al menos, una RP durante un mínimo de 6 meses, de acuerdo con el criterio del médico responsable de su tratamiento.
    - Administración de radioterapia, radioinmunoterapia, terapia biológica, quimioterapia u otro tratamiento en investigación durante las 4 semanas previas al día 1 del estudio.
    - Exposición previa a lumiliximab o a otros anticuerpos anti-CD23.
    - Transplante de médula ósea previo autólogo o alogénico o trasplante de células madre hematopoyéticas.
    - Infección confirmada por VIH, hepatitis B o hepatitis C. Aunque las pruebas de hepatitis B o hepatitis C no son obligatorias, éstas se deben considerar en todos los sujetos que presenten un riesgo alto de infección por hepatitis B o C y en áreas endémicas. Se excluyen los sujetos con evidencia serológica de exposición al virus de hepatitis B o C, tanto en el pasado como en la actualidad, a menos que los hallazgos serológicos se deban claramente a la vacunación.
    - Diabetes mellitus no controlada.
    - Hipertensión no controlada.
    - Transformación en neoplasias de células B agresivas (p. ej. linfoma de células B grandes, síndrome de Richter o leucemia prolinfocítica).
    - Neoplasias secundarias que precisen tratamiento activo (excepto hormonoterapia).
    - Cualquier patología médica que pueda requerir tratamiento prolongado (>1 mes) con corticosteroides sistémicos durante el tratamiento del estudio. Sin embargo, se permite la administración de esteroides durante 1 mes o menos a lo largo del estudio.
    - Cualquier enfermedad no maligna grave o anomalía de laboratorio que en opinión del investigador y/o el promotor pueda comprometer los objetivos del protocolo.
    - Infecciones bacterianas, virales o micosis activas y no controladas.
    - Cardiopatía de clase III o IV de la New York Heart Association, infarto de miocardio en los 6 meses previos al día 1 del estudio, arritmia inestable o evidencia de isquemia en el ECG en los 30 días previos al día 1 del estudio.
    - Trastornos convulsivos que precisen terapia anticonvulsivante.
    - Enfermedad pulmonar obstructiva crónica severa acompañada de hipoxemia.
    - Sujetos sometidos a intervenciones de cirugía mayor, que no sean con fines diagnósticos, en las 4 semanas previas al día 1 del estudio.
    - Enfermedad autoinmune clínicamente activa.
    - Antecedentes de citopenia autoinmune inducida por fludarabina (de acuerdo con el criterio del investigador) o anemia hemolítica Coombs positiva.
    - Mujeres que en la actualidad estén embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Variable principal: Índice de respuesta completa (RC)
    Variable secundaria: Supervivencia libre de progresión (SLP)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio es la última visita de seguimiento en el mes 48 del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 280
    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 Decision2007-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-07
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