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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2005-004630-41
    Sponsor's Protocol Code Number:H6Q-MC-JCBJ
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-02-24
    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 number2005-004630-41
    A.3Full title of the trial
    PRELUDE: Ensayo clínico en fase 3 para estudiar la prevención de la recaida en pacientes con linfoma mediante el tratamiento diario con enzastaurin
    A.4.1Sponsor's protocol code numberH6Q-MC-JCBJ
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 Information not present in EudraCT
    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 nameEnzastaurin
    D.3.2Product code LY317615
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnzastaurin Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1125 loading dose to then 500
    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) 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) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Linfoma b difuso de celulas grandes de alto riesgo
    MedDRA Classification
    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 es comparar el tratamiento de mantenimiento con enzastaurin frente a placebo, en función del tiempo de supervivencia global libre de enfermedad (SLE), en pacientes con LBDCG en primera remisión y con un riesgo elevado de recidiva (puntuación inicial del IPI 3) después del tratamiento con R-CHOP utilizando un esquema de 14 o de 21 días.
    E.2.2Secondary objectives of the trial
    •Comparar las siguientes variables de eficacia (tiempo hasta los diferentes eventos) entre los brazos de tratamiento:
    –tasa de SLE al cabo de dos años (SLE2)
    –supervivencia sin acontecimientos (SSA)
    –tasa de supervivencia sin acontecimientos al cabo de dos años (SSA2)
    –SG.
    •Comparar los acontecimientos adversos entre los brazos de tratamiento.
    •Comparar la calidad de vida en relación con la salud utilizando el cuestionario FACT-Lym (Cella y cols. 2005)
    •Evaluar el estado de salud utilizando la escala EQ-5D (EuroQol Group, 1990)
    •Evaluar los marcadores biológicos relevantes para enzastaurin y el estado de la enfermedad y su correlación con la evolución clínica
    •Caracterizar la farmacocinética (FC) de enzastaurin y de sus metabolitos utilizando una estrategia de muestras limitadas.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    [1]tener un diagnóstico confirmado histológicamente de LBDCG según la clasificación de la Organización Mundial de la Salud (Harris y cols., 1999) en el momento del diagnóstico inicial. La anatomía patológica debe ser revisada y confirmada antes de su inclusión en el centro de investigación en el que se incluya al paciente. Los pacientes se incluirán y aleatorizarán en base a la anatomía patológica local; no obstante, se realizará una revisión patológica independiente centralizada para todos los pacientes incluidos en el estudio (véase Sección 6.4.1). Los pacientes con antecedentes de linfoma indolente o un diagnóstico histológico de linfoma folicular de grado 3 no serán elegibles para su inclusión.
    [2]si se realiza algún escáner de galio, el más reciente debe ser negativo. Sin embargo, el escáner de galio no es un procedimiento requerido para el estudio.
    [3]si se realiza algún escáner PET, el más reciente debe ser negativo. Sin embargo, el escáner PET no es un procedimiento requerido para el estudio
    [4]haber completado seis u ocho ciclos de 21 días de R-CHOP, o seis ciclos de 14 días de R-CHOP como tratamiento de primera línea para el LBDCG. (Consulte la Sección 5.5 para ver los regímenes recomendados). El paciente debe haber alcanzado una RC o una RCnc (y no haber presentado progresión posteriormente) según los criterios del International Workshop (Cheson y cols., 1999).
    [5]tener una puntuación del IPI 3 en el momento del diagnóstico inicial (consulte el Apéndice al protocolo JCBJ.4).
    [6]haber tenido enfermedad en estadio 3 o 4, o en estadio 2 con una masa voluminosa (definida como > 10 cm), al diagnóstico inicial.
    [7]haber dado su consentimiento informado.
    [8]tener una esperanza de vida estimada de al menos 12 semanas.
    [9]tener un estadio funcional de 0, 1 o 2 en la escala del Eastern Cooperative Oncology Group (ECOG) (véase el Apéndice al protocolo JCBJ.7; Oken y cols., 1982).
    [10]cumplimiento terapéutico y proximidad geográfica del paciente que permitan un seguimiento adecuado.
    [11]tener una función orgánica adecuada, que incluya lo siguiente:
    •Función hepática: bilirrubina total 1,5 veces el límite superior de la normalidad (LSN); alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) 2,5 veces el LSN
    •Función renal: creatinina sérica <1,5 veces el LSN
    •Reservas medulares adecuadas: plaquetas 50 x 109/L, recuento absoluto de neutrófilos (RAN) 1,0 x 109/L, hemoglobina 8 g/dL.
    [12]los hombres y mujeres con capacidad reproductora deben utilizar un método anticonceptivo aprobado si procede (por ejemplo, dispositivo intrauterino [DIU], anticonceptivos orales o dispositivo de barrera) durante el tratamiento del estudio y hasta tres meses después de su interrupción. Las mujeres con capacidad de concebir deben tener una prueba de embarazo en suero negativa en los siete días previos a su inclusión en el estudio.
    [13]tener al menos 18 años de edad.
    [14]el paciente debe recibir el tratamiento del estudio no más tarde de 42 días desde el último ciclo (día 1) del tratamiento de inducción.
    E.4Principal exclusion criteria
    [15]haber recibido tratamiento en los últimos 30 días con un fármaco que no haya recibido la aprobación de las autoridades reguladoras para ninguna indicación en el momento de la inclusión en el estudio.
    [16]estar recibiendo simultáneamente cualquier otro tratamiento antineoplásico sistémico.
    [17]haber recibido radioterapia para más de una de las lesiones diana (enfermedad local residual) como tratamiento del linfoma.
    [18]embarazo o lactancia.
    [19]presencia de metástasis en el sistema nervioso central (SNC) (salvo que el paciente haya completado con éxito el tratamiento local de las metástasis del SNC y no haya recibido corticoides en las cuatro semanas previas al inicio del tratamiento del estudio). Si no hay sospecha clínica de metástasis cerebrales, no es necesario realizar cribado mediante tomografía computarizada (TC) o resonancia magnética (RM) antes de la inclusión.
    [20]tener una enfermedad grave asociada, como una infección bacteriana, fúngica o vírica activa, incompatible con el estudio (a criterio del investigador).
    [21]tener un linfoma asociado al virus de la inmunodeficiencia humana (VIH).
    [22]tener una segunda neoplasia primaria (excepto un carcinoma de células basales de la piel tratado de manera adecuada). Los pacientes que han tenido otra neoplasia maligna en el pasado y que han estado libres de enfermedad durante más de cinco años sí son elegibles.
    [23]tener una cardiopatía grave, como infarto de miocardio en los seis meses previos, angina o cardiopatía, de clase III o IV de la New York Heart Association (véase Apéndice al protocolo JCBJ.5).
    [24]incapacidad para deglutir los comprimidos.
    E.5 End points
    E.5.1Primary end point(s)
    Tiempo de supervivencia global libre de enfermedad (SLE)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Cuestionario de Calidad de Vida
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-02-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 459
    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 Decision2006-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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