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    Summary
    EudraCT Number:2008-008202-52
    Sponsor's Protocol Code Number:REMARC
    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:2010-01-22
    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 number2008-008202-52
    A.3Full title of the trial
    ESTUDIO DE FASE III, RANDOMIZADO, DOBLE CIEGO, DE MANTENIMIENTO DE LENALIDOMIDA (REVLIMID®) FRENTE A PLACEBO EN PACIENTES RESPONDEDORES DE EDAD AVANZADA CON LINFOMA DIFUSO DE CÉLULAS B GRANDES Y TRATADOS CON R-CHOP EN PRIMERA LÍNEA
    (DOUBLE BLIND RANDOMIZED PHASE III STUDY OF LENALIDOMIDE (REVLIMID®) MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH DLBCL AND TREATED WITH R-CHOP IN FIRST LINE)
    A.3.2Name or abbreviated title of the trial where available
    REMARC
    A.4.1Sponsor's protocol code numberREMARC
    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 SponsorGELARC
    B.1.3.4CountryFrance
    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 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 Yes
    D.2.1.1.1Trade name REVLIMID 25 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Capsule*
    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 INNLENALIDOMIDA
    D.3.9.3Other descriptive nameLENALIDOMIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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.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 REVLIMID 15 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Capsule*
    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 INNLENALIDOMIDA
    D.3.9.3Other descriptive nameLENALIDOMIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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.IMP: 3
    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 REVLIMID 10 mg càpsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Capsule*
    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 INNLENALIDOMIDA
    D.3.9.3Other descriptive nameLENALIDOMIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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.IMP: 4
    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 REVLIMID 5 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Capsule*
    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 INNLENALIDOMIDA
    D.3.9.3Other descriptive nameLENALIDOMIDA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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.IMP: 5
    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 nameREVLIMID
    D.3.2Product code L04AX04
    D.3.4Pharmaceutical form Capsule*
    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 INNLENALIDOMIDA
    D.3.9.3Other descriptive nameSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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 difuso de células B grandes.
    (Diffuse Large B Cell Lymphoma).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    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 determinar el beneficio estimado por la supervivencia libre de progresión asociada al mantenimiento de lenalidomida comparado con el placebo en pacientes respondedores tratados con R-CHOP en primera línea con linfoma difuso de células B grandes.
    (The primary objective is to determine the benefit estimated by the progression-free survival associated with lenalidomide maintenance compared to placebo in responding patients treated with R-CHOP for diffuse large B-cell lymphoma).
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son evaluar:
    - el porcentaje de pacientes que pasan de RP a RC
    - la eficacia según la respuesta a R-CHOP
    - la supervivencia global en ambos grupos de pacientes (con y sin mantenimiento de lenalidomida)
    - la seguridad de lenalidomida en mantenimiento.
    (The secondary objectives are to assess:
    - percentage of patients who convert from PR to CR
    - efficacy according to the response to R-CHOP
    - Overall survival in both groups of patients (with and without lenalidomide maintenance)
    - The safety of lenalidomide in maintenance)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Para pacientes inscritos en el momento del diagnóstico inicial:
    • Diagnóstico inicial con confirmación histológica de linfoma difuso de células B grandes CD20 positivo, según la clasificación de linfomas de 2008 de la Organización Mundial de la Salud
    - Está permitido el linfoma folicular de grado 3b
    - Está permitido el linfoma folicular de novo transformado
    • Pueden incluirse pacientes con alguna pequeña infiltración celular en la médula ósea (sospecha de linfoma indolente de novo transformado)
    • Sin tratamiento previo con quimio- o radioterapia

    Para pacientes inscritos tras la evaluación de respuesta al tratamiento de primera línea con R-CHOP:
    • Diagnóstico inicial con confirmación histológica de linfoma difuso de células B grandes CD20 positivo, según la clasificación de linfomas de 2008 de la Organización Mundial de la Salud
    - Está permitido el linfoma folicular de grado 3b
    - Está permitido el linfoma folicular de novo transformado
    • Ha alcanzado una RC o RP (Cheson 2007) tras un tratamiento de primera línea con al menos 6 ciclos de R-CHOP-14 y hasta 8 ciclos de R-CHOP-21
    • Sin tratamiento previo con radioterapia

    Para todos los pacientes:
    • Con edades comprendidas entre 60 y 80 años en el momento del diagnóstico inicial
    • Con estadio de Ann Arbor II-IV en el momento del diagnóstico inicial
    • Índice internacional de pronóstico ajustado a la edad (aaIPI) > 1 en el momento del diagnóstico inicial
    • Estado general 0-2 del Grupo Oncológico Cooperativo del Este [ECOG]
    • Esperanza mínima de vida de 3 meses
    • Consentimiento informado firmado voluntariamente antes de la realización de cualquier procedimiento relacionado con el estudio que no sea parte de su atención médica normal, con el entendimiento de que el consentimiento puede ser retirado en cualquier momento por el paciente sin perjuicio de su atención médica futura.
    • Los siguientes valores de laboratorio en el momento de la selección:
    - Recuento absoluto de neutrófilos (RAN) superior o igual a 1.000.106/l y de plaquetas mayor o igual a 60.000.106/l, a menos que estas anomalías estén relacionadas con la infiltración de la médula ósea.
    - Aspartato aminotransferasa sérica (AST) inferior o igual a 5 x ULN; Alanina aminotransferasa (ALT) inferior o igual a 5 x ULN; Bilirrubina total inferior o igual a 1.5 x ULN;
    - Aclaramiento de creatinina > 30 ml/min (calculado según la fórmula de Cockcroft-Gault)
    • Las mujeres en edad fértil (MEF)† deben:
    - Obtener un test de embarazo negativo supervisado médicamente antes de comenzar con la terapia en estudio. Debe aceptar realizarse tests de embarazo continuados durante el transcurso del estudio, y después del final de la terapia en estudio. Esto es aplicable incluso si la paciente practica abstinencia sexual completa y continuada.
    - Deben comprometerse o bien a una abstinencia continuada de relaciones heterosexuales (que debe ser revisada mensualmente) o acordar utilizar y ser capaz de cumplir con anticonceptivos eficaces sin interrupción, 28 días antes de iniciar el fármaco en estudio, durante la terapia del estudio (incluyendo durante periodos de interrupciones de dosis), y durante 28 días tras interrumpir la terapia del estudio.
    • Los pacientes varones deben:
    - Los hombres deben aceptar utilizar los preservativos de látex durante cualquier relación sexual con mujeres en edad fértil, incluso si se ha sometido a una vasectomía, mientras participen en este estudio, durante las interrupciones de dosis y después de la interrupción del tratamiento.
    - Los hombres también deben aceptar abstenerse de donar semen mientras participen en este estudio y durante un tiempo después de la interrupción del tratamiento (véanse los datos específicos).
    • Todos los pacientes deben:
    - Entender que el fármaco en estudio puede tener potencialmente un riesgo teratogénico.
    - Acordar abstenerse de donar sangre mientras estén tomando el tratamiento y después de la interrupción de la terapia del fármaco en estudio.
    - Acordar no compartir la medicación en estudio con nadie más.
    - Deben recibir asesoramiento sobre las precauciones ante el embarazo y los riesgos potenciales de la exposición fetal.
    (- For patients registered at time of initial diagnosis:
    1- Initial diagnosis of histologically confirmed CD20+ diffuse large B-cell Lymphoma based on the World Health Organization 2008 classification Lymphoma
    *FL grade 3b is allowed
    *De novo transformed FL is allowed
    2- Patients with some small cell infiltration in bone marrow (suspicion of de novo transformed indolent lymphoma) may be included
    3- Previously untreated with chemo- radiotherapy

    - For patients registered after response evaluation to first line treatment with R-CHOP:
    1- Diagnosis of histologically confirmed CD20+ diffuse large B-cell Lymphoma based on the World Health Organization 2008 classification Lymphoma
    *FL grade 3b is allowed
    *De novo transformed FL is allowed
    2- Have reached a CR or PR (Cheson 2007) after
    E.4Principal exclusion criteria
    Para todos los pacientes:
    • Cualquier otro tipo de linfoma
    • Cualquier antecedente de linfoma de grado bajo
    • Afectación del sistema nervioso central o de la meninge por el linfoma
    • Contraindicación a cualquier fármaco contenido en el tratamiento de quimioterapia Por ejemplo, “contraindicación cardiaca a antraciclinas (fracción de eyección ventricular izquierda definida por FEVI <50%) contraindicación neurológica a la vincristina (neuropatía periférica de grado superior o igual a 2 según la OMS).
    • Infarto de miocardio en los últimos 3 meses o enfermedad coronaria inestable o insuficiencia cardiaca congestiva sintomática crónica NYHA III - IV
    • Hipertensión descontrolada
    • Diabetes mellitus descontrolada según criterio del investigador
    • Infección sistémica activa que requiere tratamiento
    • Serología positiva previa conocida de HIV
    • Hepatitis activa, tipo B o C
    • Historial previo de afecciones distintas del linfoma en el plazo de 3 años (salvo la resección completa de carcinoma de células basales, carcinoma escamocelular de la piel, o anomalía in situ. Los pacientes diagnosticados previamente con cáncer de próstata cumplen los requisitos si (1) su enfermedad fue T1-T2a, N0, M0, con una puntuación de Gleason menor o igual a 7, y un antígeno prostático específico (PSA) inferior o igual a 10 ng/ml antes de la terapia inicial, (2) tuvieron terapia curativa definitiva (es decir, prostatectomía o radioterapia) superior o igual a 2 años antes del Día 1 del Ciclo 1, y (3) en un mínimo de 2 años tras la terapia no han tenido evidencia clínica de cáncer de próstata, y su PSA fue indetectable si se sometieron a prostatectomía o <1 ng/ml si no se sometieron a prostatectomía.
    • Enfermedad médica o psiquiátrica grave con posibilidades de que interfiera en la participación en este estudio clínico.
    (For all patients:
    1- Any other type of lymphoma.
    2- Any previous history of low grade lymphoma
    3- Central nervous system or meningeal involvement by lymphoma
    4- Contraindication to any drug contained in the chemotherapy regimen. For example: ?cardiac contra-indication to anthracyclines (alteration of Left Ventricular Function defined by LVEF<50%) neurological contra-indication to vincristine (peripheral neuropathy of WHO grade ? 2).
    5- Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic symptomatic congestive heart insufficiency NYHA III-IV
    6- Uncontrolled hypertension
    7- Uncontrolled diabetes mellitus as defined by the investigator
    8- Active systemic infection requiring treatment.
    9- Previously known HIV positive serology
    10- Active hepatitis B or C
    11- Prior history of malignancies other than lymphoma within 3 years (except for complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score < or equal to 7, and a prostate specific antigen (PSA) < or equal to 10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) ? 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
    12- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal es la supervivencia libre de progresión (SLP). La SLP se medirá desde la fecha de la aleatorización a la fecha de la primera progresión o recidiva documentada de la enfermedad evaluada por un comité de adjudicación de respuesta independiente ciego, o la muerte por cualquier causa, lo que suceda antes.
    (The primary endpoint is progression-free survival (PFS). PFS will be measured from the date of randomization to the date of first documented disease progression or relapse assessed by a blinded independent response adjudication committee, or death from any cause whichever occurs first).
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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
    The end of the trial is defined as : "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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 720
    F.4.2.2In the whole clinical trial 725
    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 Decision2010-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-30
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