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    Summary
    EudraCT Number:2009-010777-20
    Sponsor's Protocol Code Number:155-CL-031
    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:2009-10-23
    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 number2009-010777-20
    A.3Full title of the trial
    Estudio en Fase II, multicéntrico y abierto de YM155 más Rituximab en Pacientes con Linfoma No Hodgkin de células B CD20 positivas, previamente tratados, que hayan sido sometidos a autotrasplante de células madre (ATCM) o que no sean elegibles para ATCM

    A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin?s Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant
    A.4.1Sponsor's protocol code number155-CL-031
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    B.1.3.4CountryUnited States
    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 nameYM155
    D.3.2Product code YM155
    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.3.9.1CAS number 781661-94-7
    D.3.9.2Current sponsor codeYM155
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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: 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 Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal
    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 Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal
    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
    Linfoma difuso de grandes células B (LDGCB) CD20 positivas, primario o transformado, linfoma folicular (LF) Grado III o linfoma de células del manto (LCM).

    CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL), grade 3 follicular lymphoma (FL) and mantle cell lymphoma (MCL).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level HLT
    E.1.2Classification code 10029592
    E.1.2Term Non-Hodgkin's lymphomas NEC
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la tasa de respuesta global (TRG) (remisión completa [RC] + remisión parcial [RP]) conforme a [los Criterios de Respuesta Revisados para Linfoma Maligno del Grupo Internacional de Trabajo (GIT) (2007)](Apéndice 7).
    E.2.2Secondary objectives of the trial
    Evaluar lo siguiente:
    -Seguridad y tolerabilidad de YM155 administrado en combinación con rituximab.
    -Tasa de RC.
    -Tasa de RP.
    -Tiempo hasta la respuesta.
    -Duración de la respuesta.
    -Tasa de beneficio clínico (TBC).
    -Supervivencia sin progresión (SSP).
    -Supervivencia global (SG).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    El Subestudio farmacogenómico está incluido en el protocolo principal.
    Esta investigación tiene como elementos clave la búsqueda exhaustiva de:
    -Genes sospechosos asociados con la enfermedad, como los oncogenes, la survivina y el factor de crecimiento del endotelio vascular (VEGF)
    -Genes candidatos implicados en el metabolismo y la eliminación del fármaco, como los transportadores de aniones o cationes orgánicos (TAO, TCO)
    -Genes farmacológicamente relevantes desde el punto de vista de la toxicidad y la seguridad, que serán identificados de manera retrospectiva aplicando el principio de cautela.
    E.3Principal inclusion criteria
    Los sujetos deberán cumplir todos los criterios siguientes para poder participar en el estudio:
    1.Se debe obtener el consentimiento informado por escrito de todo sujeto que participe en el estudio o de su representante legal, antes de realizar cualquier procedimiento relacionado con este estudio (que incluye la retirada de la medicación prohibida, si procede). El documento de consentimiento informado debe obtener la aprobación previa del Comité Ético de Investigación Clínica (CEIC) (o del Comité de Revisión Institucional, en los centros de Estados Unidos, conforme a las disposiciones locales que incluyen la autorización basada en la Ley HIPAA).
    2. Sujetos de ambos sexos con 18 o más años de edad en el momento de la Visita Basal.
    3.Sujetos con diagnóstico de LDGCB CD20-positivo de origen primario o transformado en cualquier estadio de la enfermedad, LF en estadio III o LCM, confirmados por histología.
    4. Sujetos no elegibles para ATCM o receptores de ATCM.
    5. En recaída tras recibir la última dosis de quimioterapia sistémica o de someterse a ATCM.
    o Sujeto en recaída después de finalizar la quimioterapia sistémica o de someterse a ATCM, que haya presentado al menos una RP mantenida durante 6 meses como mínimo tras finalizar el tratamiento.
    6. Sujetos tratados previamente al menos con un régimen de quimioterapia (en ningún caso más de 3), incluido el régimen combinado con antraciclinas.
    o Cualquier terapia de mantenimiento prevista deberá considerarse como parte del régimen de tratamiento previo.
    o Cualquier régimen preparativo (quimioterapia de rescate, quimioterapia de alta dosis, radioterapia, etcétera) deberá incluirse con el ATCM como un solo régimen de tratamiento.
    7.Estado funcional ECOG (Eastern Cooperative Oncology Group) ? 1 en la visita basal.
    8.Esperanza de vida > 12 semanas en la visita basal.
    9.Presencia de al menos una lesión medible > 1,5 cm en su diámetro transversal mayor, detectada por TAC en el período de selección.
    10. Los sujetos con antecedentes de LNH de células CD20 no positivas serán elegibles para participar en este estudio si cumplen los siguientes criterios de supervivencia al cáncer:
    o Sujetos con carcinoma basocelular o de células escamosas epiteliales o carcinoma in-situ del cuello uterino, que hayan recibido algún tratamiento potencialmente curativo en cualquier momento previo a la inclusión.
    o Sujetos que hayan recibido algún tratamiento potencialmente curativo para todo proceso maligno previo, y que no hayan presentado enfermedad durante al menos 5 años.
    11.En el caso de las mujeres, no deben estar embarazadas ni en período de lactancia durante la Visita Basal. Todo hombre o mujer sexualmente activo y en edad fértil debe comprometerse a usar un método anticonceptivo adecuado (de doble barrera) durante todo el estudio.
    E.4Principal exclusion criteria
    No podrán participar en este estudio los sujetos que cumplan alguno de los siguientes criterios:
    1. Cualquier tratamiento estándar o experimental contra el linfoma en los 21 días previos a la visita basal.
    2.Uso de esteroides sistémicos en los 5 días previos a la visita basal.
    o Todo sujeto tratado con esteroides en el momento de la visita basal, es elegible para participar a condición de que esté recibiendo una dosis biológica o haya sido tratado con una dosis estable no biológica al menos durante las 4 semanas previas a la primera infusión de YM155, siempre y cuando se prevea que continuará recibiendo una dosis estable no biológica durante su participación en el estudio.
    3. Trasplante alogénico previo de células madre (TCM).
    4. Funcionamiento inadecuado de médula ósea o de la función hepática o renal en el momento de la visita basal, definido como:
    o Creatinina sérica ? 1,5 x respecto al límite superior de la normalidad (LSN) o aclaramiento de creatinina sérica calculado < 60 ml/min.
    o Recuento absoluto de neutrófilos (ANC) ? 1000/mm3.
    o Plaquetas ? 100,000/mm3.
    o Alanina transaminasa (ALAT) y aspartato aminotransferasa (ASAT) ? 2,5 x LSN; ? 5 x LSN si fuera secundario a metástasis hepática.
    5. Afectación del sistema nervioso central (SNC) o infiltración leptomeníngea por linfoma, según determinaciones del Investigador por exploración física y anamnesis en la visita basal.
    6. Alteraciones cardiacas, renales o hepáticas significativas o no controladas u otros trastornos sistémicos o psicológicos importantes en el momento de la visita basal que, según el criterio del Investigador, puedan hacer peligrar la inclusión del sujeto en el estudio o su cumplimiento con los procedimientos del estudio.
    7. Infección conocida por el virus de la inmunodeficiencia humana (VIH), antígeno de superficie de la Hepatitis B o anticuerpo contra el virus de la hepatitis C.
    8. Tratamiento previo con YM155.
    9. Administración de otro tratamiento en investigación o aplicación de un procedimiento experimental en los 28 días previos a la primera administración de la medicación del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La tasa de respuesta objetiva (TRG) es el criterio principal de valoración de este estudio. La TRG se define como la proporción de sujetos con RC o RP según la evaluación realizada por un tercer experto independiente durante el estudio, conforme a los Criterios de Respuesta Revisados para Linfomas Malignos del Grupo Internacional de Trabajo (GIT, 2007).
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarcadores de eficacia potenciales
    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 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.8.3 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 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 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 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
    Fecha en la que el sujeto recibe el último contacto para seguimiento de la supervivencia. Esta fecha podría incluir una visita del estudio, un contacto telefónico con el paciente, etcétera.
    Definición expuesta en el protocolo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 60
    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 Decision2010-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
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