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    Summary
    EudraCT Number:2009-016026-13
    Sponsor's Protocol Code Number:O-ESHAP-LH-2009
    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:2010-03-11
    Trial 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 number2009-016026-13
    A.3Full title of the trial
    Estudio de fase II de uso de anticuerpo monoclonal anti-CD20 (ofatumumab) más ESHAP seguido de trasplante autólogo de progenitores hemopoyéticos para el tratamiento de linfoma de Hodgkin clásico en recaída, respuesta parcial o refractario a tratamiento de primera línea
    A.4.1Sponsor's protocol code numberO-ESHAP-LH-2009
    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 SponsorFUNDACION GELTAMO
    B.1.3.4CountrySpain
    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 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 nameOFATUMUMAB
    D.3.2Product code GSK1841157
    D.3.4Pharmaceutical form Solution for injection
    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 INNOFATUMUMAB
    D.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeGSK1841157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    EL PRESENTE ESTUDIO PROPONE TRATAR PACIENTES CON LINFOMA DE HODGKIN CLASICO REFRACTARIO, EN RESPUESTA PARCIAL O RECAIDA CON QUIMIOTERAPIA SEGUN DOSIS ESTANDAR DE ESHAP EN COMBINACION CON OFATUMUMAB CON LA FINALIDAD DE AUMENTAR LA TASA DE RESPUESTA GLOBAL Y DE REMISION COMPLETA PREVIO A UN TRASPLANTE AUTOLOGO DE PROGENITORES HEMOPOYETICOS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ANALISIS DE LA TASA DE RESPUESTA GLOBAL (RESPUESTAS COMPLETAS + RESPUESTAS PARCIALES) TRAS O-ESHAP
    E.2.2Secondary objectives of the trial
    - ANALISIS DE LA TASA DE RESPUESTA COMPLETA TRAS O-ESHAP
    - ANALISIS DE LA TOXICIDAD DEL REGIMEN O-ESHAP
    - ANALISIS DE LA CAPACIDAD DE MOVILIZACION DE PROGENITORES HEMOPOYETICOS A SANGRE PERIFERICA DE O-ESHAP
    - DESCRIPCION DE LOS RESULTADOS FINALES DEL PROCEDIMIENTO TERAPEUTICO COMPLETO (O-ESHAP SEGUIDO DE ALTAS DOSIS DE QUIMIOTERAPIA Y TAPH) EN TERMINOS DE: MORTALIDAD RELACIONADA CON EL TRASPLANTE (MRT), SUPERVIVENCIA GLOBAL (SG), SUPERVIVENCIA LIBRE DE EVENTO (SLE) Y LIBRE DE PROGRESION (SLP).
    - INVESTIGAR LA RELACIÓN ENTRE LA RESPUESTA GLOBAL A O-ESHAP Y LA EXPRESION POR LAS CELULAS TUMORALES DE CD20 Y EL CONTENIDO DE CELULAS CD34+CD20+ EN EL PRODUCTO DE LEUCAFERESIS
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    En el presente estudio se pretende testar las siguientes hipótesis correlacionando el efecto terapéutico anti-CD20 y la composición histológica del tumor previa al tratamiento con la combinación de un fármaco anti-CD20, ofatumumab, y quimioterapia, ESHAP:

    • La terapia anti-CD20 puede ser efectiva en aquellos casos que expresan CD20.
    • La terapia anti-CD20 puede ser efectiva en todos los casos al tener como diana una hipotética célula precursora del tumor, ”cancer stem cell”, que expresaría CD20.
    • La terapia anti-CD20 en realidad actuaría regulando la población B no tumoral, y ejerciendo un efecto indirecto inmunomodulador sobre el background reactivo del tumor.

    Para ello se pretende evaluar en todas las muestras lo siguiente:
    a. Expresión de CD20 por las células tumorales.
    b. Expresión de otros marcadores característicos del fenotipo B por parte de las células tumorales: CD79a, PAX5, BCL6, OCT2, sIgs
    c. Cuantificación de células B CD20+ no neoplásicas en el fondo reactivo no tumoral: se utilizará el scanner ACIS III (Dako) para la cuantificación automática de la expresión de CD20.

    E.3Principal inclusion criteria
    • Pacientes con LH variedad clásica refractarios, en respuesta parcial, o en recaída
    tras quimioterapia de primera línea.* Se incluirán independientemente de la
    expresión del antígeno CD20 por las células tumorales HRS.
    • Edad de 18 a 65 años. Los pacientes entre 66 y 75 años con ECOG < 2 y sin comorbilidades
    podrán incluirse en el estudio si el investigador lo considera
    candidato a TAPH.
    • Leucocitos > 3,0 x 109/L y plaquetas > 100 x 109/L.
    • ECOG < 2.
    • Ausencia de disfunción orgánica mayor.
    • Consentimiento informado escrito.
    • Serología para VIH negativa.
    • Serología para VHB y VHC negativas.
    • Biopsia tumoral diagnóstica de LH variedad clásica en el momento de la recaída o
    de la consideración de refractariedad, previo al inicio del tratamiento de rescate
    con O-ESHAP. En caso de que por la localización del tumor no sea factible la
    realización de dicha biopsia se requerirá disponibilidad del informe
    anatomopatológico y/o material de biopsia al diagnóstico inicial para la inclusión
    del paciente en el ensayo. Dicha biopsia podrá ser revisado por un patólogo de
    referencia en caso de ser requerido.
    • Ausencia de otra neoplasia con excepción de tumor basocelular o de carcinoma
    de cuello uterino in situ.
    11. Los adultos con capacidad de procrear deben comprometerse a utilizar un método eficaz de control de natalidad durante el tratamiento del estudio y como mínimo 6 meses después. Entendiéndose como método eficaz aquel en el que se utilice al menos un mecanismo de barrera.
    E.4Principal exclusion criteria
    • Alteración grave de las funciones hepática o renal.
    • Presencia de patología que contraindique la administración de quimioterapia.
    • Infección por VIH.
    • Infección por VHB o VHC.
    • Antecedentes de otras neoplasias además de las especificadas en los criterios de
    inclusión.
    • No haber firmado el consentimiento informado.
    Mujeres embarazadas y/o en periodo de lactancia, o adultos con capacidad de procrear que no utilicen un método eficaz de control de natalidad durante el tratamiento del estudio y como mínimo 6 meses después. Entendiéndose como método eficaz aquel en el que se utilice al menos un mecanismo de barrera.
    • Tratamiento previo con anticuerpos monoclonales anti-CD20 tipo Rituximab.
    E.5 End points
    E.5.1Primary end point(s)
    TASA DE RESPUESTA GLOBAL (RESPUESTAS COMPLETAS + RESPUESTAS PARCIALES) TRAS O-ESHAP
    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 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) 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 concerned14
    E.8.5The trial involves multiple Member States No
    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 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
    - AUSENCIA DE RESPUESTA EN MAS DE 6 PACIENTES DE LOS PRIMEROS 23 PACIENTES INCLUIDOS EN EL ENSAYO.
    - TOXICIDAD HEMATOLOGICA GRADOS 3-4 EN MAS DE 11 DE LOS PRIMEROS 23 PACIENTES INCLUIDOS EN EL ENSAYO.
    - TOXICIDAD EXTRA-HEMATOLOGICA GRADOS 2-3 EN MAS DE 4 DE LOS PRIMEROS 19 PACIENTES INCLUIDOS EN EL ENSAYO.
    - EXITUS POR COMPLICACIONES DERIVADAS DEL TRATAMIENTO EN MAS DE 1 PACIENTE DE LOS PRIMEROS 23 INCLUIDOS EN EL ENSAYO
    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 months0
    E.8.9.1In the Member State concerned 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 state63
    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 Decision2010-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
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