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    Summary
    EudraCT Number:2011-003657-26
    Sponsor's Protocol Code Number:ARD10248
    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:2011-11-22
    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 number2011-003657-26
    A.3Full title of the trial
    An open label non-randomized phase 2 study evaluating SAR3419, an anti-CD19 antibody ? maytansine conjugate, administered as single agent by intravenous infusion to patients with relapsed or refractory CD19+ diffuse large B cell lymphoma
    Estudio abierto, no aleatorizado, de fase 2, en el que se estudia SAR3419, un anticuerpo anti-CD19 conjugado con maitansina, administrado como monoterapia por infusión intravenosa a pacientes con linfoma B difuso de células grandes CD19+ recidivante o refractario al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SAR3419 as single agent in relapsed-refractory diffuse large B-cell
    lymphoma (DLBCL) patients
    SAR3419 en monoterapia en pacientes con linfoma B difuso de células grandes CD19+ recidivante o refractario al tratamiento
    A.4.1Sponsor's protocol code numberARD10248
    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 Sponsorsanofi aventis recherche et développement
    B.1.3.4CountryFrance
    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 supportsanofi-aventis recherche et développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointCSU Director
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 5ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934859466
    B.5.5Fax number+34934895466
    B.5.6E-mailbibiana.figueres@sanofi-aventis.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.3.2Product code SAR3419
    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 codeSAR3419
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 No
    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 typeAnti CD-19 antibody maytansine conjugate
    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
    Diffuse large B-cell lymphoma
    Linfoma B difuso de células grandes
    E.1.1.1Medical condition in easily understood language
    Diffuse large B-cell lymphoma
    Linfoma B difuso de células grandes
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective Response Rate
    Tasa de respuesta objetiva
    E.2.2Secondary objectives of the trial
    Safety, Response Duration, Progression Free Survival, Overall Survival
    Seguridad, duración de la respuesta, supervivencia libre de progresión y supervivencia global
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) based on recent (less than 3 months) or new biopsy, expressing CD19 by immunohistochemistry or flow
    cytometry analysis (at least or more than 30% positivity).
    ? At least 1 and not more than 2 prior specific therapeutic regimens, one of which should have included rituximab
    ? Relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy
    one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last
    therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion.
    ? Available paraffin-embedded tissue should have been collected no longer than 3 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not
    available, a Fine Needle Aspiration (FNA) must be obtained.
    ? Signed written informed consent
    I 01. Diagnóstico histológico de LBDCG (de novo o transformado) sobre la base de una biopsia reciente (menos de 3 meses) o de nueva biopsia, que exprese CD19 tras análisis inmunohistoquímico o mediante citometría de flujo (positividad >30%).
    I 02. Por lo menos 1 y no más de 2 regímenes terapéuticos específicos previos, uno de los cuales debe haber incluido rituximab.
    I 03. Enfermedad recidivante después del tratamiento de referencia de 1ª línea para el linfoma agresivo (no aptos para recibir quimioterapia a dosis altas con refuerzo de células madre), o bien enfermedad
    recidivante o refractaria al tratamiento después de dos líneas de tratamiento, una de las cuales podría haber incluido TACM. Se define enfermedad recidivante como la progresión después de un intervalo libre de enfermedad de al menos 6 meses después del último tratamiento. Se define enfermedad refractaria al tratamiento como la progresión de la enfermedad durante el tratamiento previo o en el transcurso de 6 meses a partir de su finalización.
    I 04. Es necesario disponer de tejidos incluidos en parafina recogidos no más de 3 meses antes de la primera administración de SAR3419. No está permitido el uso de tejidos criopreservados. Si no se dispone del material de archivo, se ha de obtener una punción aspiración con aguja fina (PAAF).
    I 05. Firma del consentimiento informado por escrito
    E.4Principal exclusion criteria
    ? Primary refractory patients
    ? Patients with primary mediastinal DLBCL
    E 01. Pacientes refractarios al tratamiento primario
    E 02. Pacientes con LBDCG primario mediastínico
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate
    Tasa de respuesta objetiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 meses
    E.5.2Secondary end point(s)
    Safety
    Response Duration, Progression Free Survival, Overall Survival
    Seguridad, duración de la respuesta, supervivencia libre de progresión y supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety : treatment period
    Response Duration, Progression Free Survival, Overall Survival : up to 18 months after the first infusion of the last patient
    Seguridad: periodo de tratamiento
    Duración de la respuesta, supervivencia libre de progresión y supervivencia global: hasta 18 meses después de la primera infusión del último paciente
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Australia
    Israel
    United States
    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
    All patients, regardless they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.
    Todos los pacientes, sin tener en cuenta si han progresado o no, serán seguidos hasta la muerte o fin de estudio para evaluar la supervivencia durante al menos 18 meses
    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 months6
    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 months6
    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 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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 36
    F.4.2.2In the whole clinical trial 55
    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)
    Not Applicable
    No aplica
    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 Decision2012-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-04
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