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    Summary
    EudraCT Number:2011-002565-38
    Sponsor's Protocol Code Number:CD-ON-MEDI-551-1088
    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:2012-03-29
    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 number2011-002565-38
    A.3Full title of the trial
    A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL
    Estudio Estudio en fase 2, aleatorizado y abierto, para evaluación de MEDI-551 en adultos con linfoma B difuso de células grandes (LBDCG) recidivante o resistente al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
    Estudio Estudio en fase 2, aleatorizado y abierto, para evaluación de MEDI-551 en adultos con linfoma B difuso de células grandes (LBDCG) recidivante o resistente al tratamiento
    A.4.1Sponsor's protocol code numberCD-ON-MEDI-551-1088
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01453205
    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 SponsorMedImmune, LLC
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number301398-4012
    B.5.5Fax number301398-4012
    B.5.6E-mailclinicaltrialenquiries@medimmune.com
    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 nameMEDI-551
    D.3.2Product code MEDI-551
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMEDI-551
    D.3.9.3Other descriptive namea-fucosylated anti-CD19 antibody
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody // Anticuerpo monoclonal
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody/ Anticuerpo mononuclear.
    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
    Relapsed or refractory diffuse large B-cell lymphoma(DLBCL)
    En recaída o refractario difuso de células B grandes (DLBCL)
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory diffuse large B-cell lymphoma(DLBCL)
    En recaída o refractario difuso de células B grandes (DLBCL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosafamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Sem Cell Tansplant (ASCT), has superior efficacy compared to rituximab in the same population.
    Determinar si MEDI-551, cuando se utiliza en combinación con la quimioterapia de rescate, Ifosafamide-carboplatino-etopósido (ICE) o la dexametasona citarabina (DHAP) en pacientes con DLBCL recidivante o refractaria que son elegibles para Tansplant autólogo de células Sem (ASCT), tiene mejores eficacia en comparación con rituximab en la misma población.
    E.2.2Secondary objectives of the trial
    Evaluate anti-tumor activities and overall survival (OS),to determine an acceptable dose for MEDI-551 when used in combination with ICE or DHAP, to describe the safety and tolerability, to determine the immunogenicity (IM), and to describe the pharmacokinetic (PK) profile.
    Evaluar las actividades anti-tumoral y la supervivencia global (OS), para determinar una dosis aceptable de MEDI-551 cuando se utiliza en combinación con el ICE o DHAP, para describir la seguridad y tolerabilidad, para determinar la inmunogenicidad (IM), y para describir la farmacocinética (PK) de perfil.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL & Grade III FL
    ? Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy
    ? Eligible for ASCT
    ? Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    ? Life expectancy of ? 12 weeks
    ? Adequate hematological function
    Confirmación histológica de células B agresivo DLBCL, incluida la transformación de DLBCL y Grado III FL FL
    Recaída o refractario a rituximab para el tratamiento por lo menos uno con otro, o la inmunoterapia basada en anti-CD20 en combinación con quimioterapia con antraciclina o antracenediona Elegible para ASCT
    Eastern Cooperative Oncology Group (ECOG) estado funcional de 0, 1 ó 2
    Esperanza de vida de ? 12 semanas
    Función hematológica adecuada
    E.4Principal exclusion criteria
    ? Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
    ? Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
    ? Prior autologous or allogeneic SCT
    ? New York Heart Association ? Class II congestive heart failure;
    ? Clinically significant abnormality on ECG
    ? History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.
    ? Evidence of active infection
    ? Documented current central nervous system involvement by leukemia or lymphoma
    ? Cualquier quimioterapia, radioterapia, inmunoterapia, biológicos, de investigación o terapia hormonal para el tratamiento del linfoma de un plazo de 28 días antes del tratamiento
    ? terapia del cáncer anterior de que no antraciclina o rituximab en monoterapia basada antracenediona quimioinmunoterapia, DLBCL antes de la terapia de primera línea y / o como terapia de mantenimiento, o la radioterapia de campo limitado
    ? Antes de SCT autólogo o alogénico
    ? New York Heart Association Clase II ? insuficiencia cardíaca congestiva;
    ? clínicamente significativas anomalías en el ECG
    ? Historia de malignidad invasivo en 5 años a excepción de los carcinomas localizados / in situ, como el carcinoma cervical in situ.
    ? La evidencia de infección activa
    ? documentados actual del sistema nervioso central por leucemia o linfoma
    E.5 End points
    E.5.1Primary end point(s)
    The overall response rate (ORR), including Partial Response (PR) and Complete Response (CR), of subjects treated with MEDI-551 when used in combination with ICE or DHAP versus rituximab in combination with ICE or DHAP in subjects with relapsed or refractory DLBCL.
    La tasa de respuesta general (ORR), incluyendo la respuesta parcial (RP) y la respuesta completa (RC), de los sujetos tratados con MEDI-551 cuando se utiliza en combinación con el ICE o DHAP frente a rituximab en combinación con el ICE o DHAP en pacientes con recaída o refractario DLBCL.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1080
    1080 dias
    E.5.2Secondary end point(s)
    Antitumor activity: Includes complete response rate, Minimal residual disease negative complete response rate, time to response (TTR), time to progression (TTP), progression-free survival (PFS), and overall survival (OS)

    Acceptable Dose: Benefit/Risk Analysis of Safety and Efficacy to be determined

    Safety and Tolerability: The safety endpoints include Adverse Events (AEs), Serious Adverse Events (SAEs) occurring during the protocol-specified reporting period and changes in clinical laboratory evaluations, Electrocardiogram (ECGs), vital signs, and weight from baseline.

    Immunogenicity (IM): Number and percentage of subjects who develop detectable anti-drug antibodies

    Pharmacokinetics (PK): Area Under Curve, CMAX, T1-half
    La actividad antitumoral: Incluye tasa de respuesta completa, la enfermedad residual mínima negativa tasa de respuesta completa, el tiempo de respuesta (TTR), tiempo hasta la progresión (TTP), supervivencia libre de progresión (SLP) y supervivencia global (SG)
    Dosis aceptable: beneficio / riesgo de Análisis de la seguridad y eficacia que se determine
    Seguridad y tolerabilidad: Los criterios de valoración de seguridad incluyen eventos adversos (EA), eventos adversos graves (AAG) que ocurren durante el período especificado en el protocolo de información y cambios en las pruebas de laboratorio clínico, electrocardiograma (ECG), signos vitales, y el peso desde el inicio.
    Inmunogenicidad (IM): Número y porcentaje de sujetos que desarrollan detectar anticuerpos anti-drogas
    Farmacocinética (PK): área bajo la curva, CMAX, T1-medio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Antitumor activity: Study Day 1080
    Acceptable dose: Study Day 42
    Safety and Tolerability: Study Day 1080
    IM: Up to Study Day 1080
    PK: Study Day 1; Study Day 8; Study Day 12; Study Day 19; Study Day 26; Study Day 54; Study Day 110; Study Day 138; Study Day 166
    La actividad antitumoral: Jornada de Estudio 1080
    Aceptable dosis: Jornada de Estudio 42
    Seguridad y tolerabilidad: Jornada de Estudio 1080
    IM: Hasta el día de Estudio 1080
    PK: Jornada de Estudio 1, el Día de Estudio 8, el Día de Estudio 12, el Día de Estudio 19, el Día de Estudio 26, el Día de Estudio 54, Jornada de Estudio 110, Jornada de Estudio 138, Jornada de Estudio 166
    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 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 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 Yes
    E.8.2.3.1Comparator description
    rituximab
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Poland
    Russian Federation
    Spain
    United States
    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 study (?study completion?) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) in the study. This date will be after a total of 90 deaths occur in the selected MEDI-551 dose arm and the rituximab arm or 36 months after the date of randomization for the last subject, or the date the sponsor stops the trial, whichever occurs first.
    Al final del estudio ("completar el estudio") se define como la fecha de la última visita especificado en el protocolo / evaluación (incluyendo teléfono de contacto) en el estudio. Esta fecha será después de un total de 90 muertes se producen en el grupo seleccionado MEDI-551 dosis y el grupo de rituximab o 36 meses después de la fecha de asignación al azar para el último tema, o la fecha en que el patrocinador se detiene el proceso, lo que ocurra primero.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days2
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 127
    F.4.2.2In the whole clinical trial 170
    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)
    See protocol section....
    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 Decision2012-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-17
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