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    Summary
    EudraCT Number:2013-000232-10
    Sponsor's Protocol Code Number:C25007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-10-01
    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 number2013-000232-10
    A.3Full title of the trial
    A Single-arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Are Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy
    Estudio con un único grupo de tratamiento para evaluar brentuximab vedotina en pacientes con linfoma de Hodgkin en recaída o refractario que no son idóneos para recibir un trasplante de células madre o un tratamiento poliquimioterápico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 4 Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy
    Estudio con un único grupo de tratamiento para evaluar brentuximab vedotina en pacientes con linfoma de Hodgkin en recaída o refractario que no son idóneos para recibir un trasplante de células madre o un tratamiento poliquimioterápico
    A.4.1Sponsor's protocol code numberC25007
    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 SponsorMillennium Pharmaceuticals, Inc
    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 supportMillennium Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium, Drug Information Call Centre
    B.5.2Functional name of contact pointDrug Information Call Centre
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, Massachussetts
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+115107402412
    B.5.5Fax number+118008816092
    B.5.6E-mailmedical@mlnm.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 Yes
    D.2.1.1.1Trade name ADCETRIS
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Global Research and Development Center (Europe) 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/595
    D.3 Description of the IMP
    D.3.1Product nameADCETRIS
    D.3.2Product code SGN-35
    D.3.4Pharmaceutical form Powder for 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 INNBrentuximab vedotin
    D.3.9.1CAS number 914088-09-8
    D.3.9.2Current sponsor codeSGN-35
    D.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB32397
    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 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 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
    Relapsed or Refractory Hodgkin Lymphoma
    Linfoma de Hodgkin en recaída o refractario
    E.1.1.1Medical condition in easily understood language
    A type of cancer of lymph tissue
    Un tipo de cáncer del tejido linfático
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level HLGT
    E.1.2Classification code 10025319
    E.1.2Term Lymphomas Hodgkin's disease
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the antitumor efficacy, as determined by the objective response rate (ORR) of
    single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks,
    in patients with relapsed or refractory classical HL who are considered to be not suitable for
    SCT or multiagent chemotherapy
    Evaluar la eficacia antineoplásica, de acuerdo con la tasa de respuestas objetivas (TRO) de brentuximab vedotina en monoterapia (1,8 mg/kg, administrados por vía intravenosa [IV] cada 3 semanas), en pacientes con LH clásico en recaída o refractario, que no se consideren idóneos para recibir un TCM o un tratamiento poliquimioterápico.
    E.2.2Secondary objectives of the trial
    To determine the duration of tumor control, including the duration of response (DOR),
    progression-free survival (PFS), and complete remission (CR) rate by independent review
    facility (IRF) assessment after treatment with brentuximab vedotin
    To determine the proportion of patients who receive hematopoietic SCT, either autologous
    stem cell transplantation (ASCT) or allogeneic stem cell transplantation (alloSCT) after
    treatment with brentuximab vedotin
    To determine overall survival (OS) after treatment with brentuximab vedotin
    To assess the safety and tolerability of brentuximab vedotin in this patient population
    To assess the pharmacokinetics (PK) of brentuximab vedotin
    To determine the immunogenicity of brentuximab vedotin
    Determinar la duración del control tumoral, incluida la duración de la respuesta (DdR), la supervivencia sin progresión (SSP) y la tasa de remisión completa (RC), tras el tratamiento con brentuximab vedotina, de acuerdo con la evaluación efectuada por un centro de revisión independiente (CRI). Determinar la proporción de pacientes que reciban trasplantes de células madre hematopoyéticas (bien autotrasplante [autoTCM] o alotrasplante [aloTCM]) tras el tratamiento con brentuximab vedotina. Determinar la supervivencia global (SG) tras el tratamiento con brentuximab vedotina. Evaluar la seguridad y tolerabilidad de brentuximab vedotina en esta población de pacientes. Evaluar la farmacocinética (FC) de brentuximab vedotina. Determinar la inmunogenia de brentuximab vedotina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients 18 years or older.
    A diagnosis of relapsed or refractory classical HL, confirmed by biopsy if clinically
    feasible on the basis of local pathology review.
    A history of at least 1 prior systemic chemotherapeutic regimen.
    Not suitable for SCT or multiagent chemotherapy
    Bidimensional measurable disease, of at least 1.5 cm, as documented by radiographic
    technique (spiral CT scan preferred), per IWG Revised Response Criteria for
    Malignant Lymphoma.
    Patients must have completed any prior immunotherapy (eg, rituximab) or
    radioisotopic therapy at least 12 weeks before the first dose of brentuximab vedotin
    in the absence of clear disease progression.
    Patient has recovered to Grade 1 or lower toxicity related to radiotherapy,
    immunotherapy, and chemotherapy unless evidence of toxicity is due to underlying
    HL. If toxicity is related to underlying HL, Grade 2 or lower toxicity is acceptable
    1. Pacientes de ambos sexos de ? 18 años de edad.
    2. Diagnóstico de LH clásico en recaída o refractario, de acuerdo con la revisión patológica realizada localmente, y confirmado mediante biopsia, si ello es viable desde un punto de vista clínico.
    Antecedentes de al menos 1 tratamiento quimioterápico sistémico previo.
    4. No considerarse idóneo para recibir un TCM o un tratamiento poliquimioterápico
    Presentar enfermedad bidimensional mensurable de al menos 1,5 cm, documentado mediante una técnica radiográfica (preferentemente TC helicoidal), de acuerdo con los Criterios Revisados para la Evaluación de la Respuesta en el Linfoma Maligno del Grupo de Trabajo Internacional. (1)
    6. Presentar al menos 1 de las siguientes evidencias de la presencia de LH clásico en recaída o refractario
    Los pacientes deberán haber completado cualquier tratamiento inmunoterápico (por ejemplo, rituximab) o radioisotópico previo, al menos 12 semanas antes de la primera dosis de brentuximab vedotina, en ausencia de una progresión clara de la enfermedad.
    8. El paciente deberá haberse recuperado de cualquier toxicidad relacionada con la radioterapia, inmunoterapia y quimioterapia (esto es, deberá presentar una toxicidad de grado ? 1), a menos que existan indicios que indiquen que la toxicidad se deba al LH subyacente. Si la toxicidad está relacionada con el LH subyacente, es aceptable que el paciente presente una toxicidad ? 2.
    E.4Principal exclusion criteria
    1. Previous treatment with brentuximab vedotin.
    2. Previously received an ASCT or alloSCT.
    3. Female patients who are lactating and breastfeeding or have a positive serum or urine
    pregnancy test during the Screening period or a positive serum or urine pregnancy
    test on Day 1 before first dose of study drug.
    4. Any serious medical or psychiatric illness that could, in the investigator?s opinion,
    potentially interfere with the completion of treatment according to this protocol.
    5. Treatment with any investigational products within 4 weeks before the first dose of
    study drug.
    6. Any of the following cardiovascular conditions or values within 6 months before the
    first dose of study drug:
    - New York Heart Association Class III or IV heart failure (refer to
    Section 15.3)
    - Myocardial infarction within 6 months before the first dose of study drug
    - Evidence of current uncontrolled cardiovascular conditions, including
    clinically relevant cardiac arrhythmias, congestive heart failure (CHF),
    angina, or electrocardiographic evidence of acute ischemia or active
    conduction system abnormalities
    7. History of another primary malignancy that has not been in remission for at least
    3 years. (The following are exempt from the 3-year limit: nonmelanoma skin
    cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on
    biopsy or a squamous intraepithelial lesion on PAP smear.)
    8. Any active uncontrolled systemic viral, bacterial, or fungal infection.
    9. Any antimicrobial, antiviral, or antifungal therapy within 1 week prior to the first
    dose of brentuximab vedotin (routine prophylaxis is acceptable).
    10. Known cerebral/meningeal disease, including signs or symptoms suggestive of PML,
    or any history of PML.
    11. Known human immunodeficiency virus (HIV).
    12. Known hepatitis B surface antigen positive, or known or suspected active hepatitis C
    infection.
    13. Grade 2 or higher peripheral neuropathy.
    Current therapy with other systemic antineoplastic or investigational agents.
    15. Therapy with corticosteroids at higher than or equal to 20 mg/day of prednisone
    equivalent within 1 week before administration of the first dose of brentuximab
    vedotin.
    16. Patients with a known hypersensitivity to recombinant proteins, murine proteins, or
    any excipient contained in the drug formulation.
    17. Patients with dementia or an altered mental state that would preclude the
    understanding and rendering of informed consent.
    1. Tratamiento previo con brentuximab vedotina.
    2. Haber recibido previamente un autoTCM o un aloTCM.
    3. Pacientes que estén en período de lactancia o hayan presentado un resultado positivo en una prueba de embarazo en suero u orina
    4. Presentar una enfermedad grave (incluidos los trastornos psiquiátricos) que, en opinión del investigador, podría interferir con el cumplimiento terapéutico del paciente, de acuerdo con este protocolo.
    5. Tratamiento con cualquier producto en fase de investigación, en el transcurso de las 4 semanas previas a la primera dosis del fármaco del estudio.
    6. Presentar cualquiera de las siguientes enfermedades o valores cardiovasculares en el transcurso de los 6 meses previos a la administración de la primera dosis del fármaco del estudio: Insuficiencia cardiaca de clase III o IV, de acuerdo con los criterios de la New York Heart Association (NYHA) (véase el apartado 15.3). Infarto de miocardio en el transcurso de los 6 meses previos a la primera dosis del fármaco del estudio. Presentar en la actualidad indicios de enfermedades cardiovasculares sin controlar, entre otras, arritmias cardiacas, insuficiencia cardiaca congestiva (ICC), angina de pecho o indicios electrocardiográficos de isquemia aguda clínicamente relevantes, o alteraciones activas del sistema de conducción.
    7. Antecedentes de otra neoplasia maligna primaria que no haya permanecido en remisión al menos durante 3 años. Los siguientes tipos de cáncer no están incluidos en dicho límite temporal de 3 años: cáncer de piel no melanomatoso, cáncer de próstata localizado, tratado con intención curativa, y carcinoma de cuello uterino in situ (de acuerdo con los resultados de una biopsia) o una lesión intraepitelial escamosa (de acuerdo con los resultados de un frotis de Pap).
    8. Cualquier infección sistémica activa sin controlar (fúngica, bacteriana o vírica).
    9. Administración de cualquier tratamiento antimicrobiano, antivírico o antifúngico, en el transcurso de la semana previa a la primera dosis de brentuximab vedotina (se acepta la administración de un tratamiento profiláctico rutinario).
    10. Presentar enfermedad cerebral o meníngea, incluidos signos y síntomas indicativos de LMP o cualquier antecedente de LMP.
    11. Presentar infección por el virus de la inmunodeficiencia humana (VIH).
    12. Presentar resultados positivos para el antígeno de superficie de la hepatitis B o infección activa por hepatitis C (conocida o sospechada).
    13. Neuropatía periférica de grado ? 2.
    14. Tratamiento actual con otros fármacos antineoplásicos sistémicos o con fármacos en fase de investigación.
    15. Tratamiento con corticosteroides (a una dosis equivalente de prednisona ? 20 mg/día), en el transcurso de la semana previa a la administración de la primera dosis de brentuximab vedotina).
    16. Presentar hipersensibilidad conocida a proteínas recombinantes, proteínas murinas o a cualquier excipiente incluido en la formulación del fármaco.
    17. Pacientes con demencia o un estado mental alterado, que les impediría comprender y proporcionar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) per independent review facility
    (IRF)
    Ratio de respuesta objetiva según un servicio de revisión independiente
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Screening
    - At the End of Treatment Visit: 30 days after last dose of study drug
    - During the follow up period: Every 3 months for 18 months from EOT or until the sooner of disease progression, death or study closure.Overall survival data will be collected every 3 months from EOT for 18 months, then every 6 months thereafter until the sooner of death or study closure.
    - Selección
    - EN la visita de fin de tratamiento: 30 días después de la útlima dosis del fármaco del estudio.
    - Durante el periodo de seguimiento: cada 3 meses en los 18 meses desde el Fin da tratamiento o progresión de la enfermedad, muerte o cierre del estudio, lo que ocurra antes, después, cada 6 meses hasta muerte o cierre del estudio, lo que ocurra antes.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    -Duration of response, PFS, CR rate, and duration of CR, by IRF assessment
    Proportion of patients who receive SCT after treatment with brentuximab vedotin
    -OS
    -Incidence, severity, and relatedness of AEs; SAEs; and clinical laboratory
    abnormalities
    -PK for brentuximab vedotin, MMAE, and total antibody
    -Determine the Immunogenecity

    The exploratory endpoints are:
    -TTP, time to response (either CR or PR), time to best response, and time to CR, by
    IRF assessment
    -Serum and/or plasma concentrations of serum biomarkers, sCD30, IL-6, and TARC
    -B symptom resolution rate
    -Health care utilization data
    Determinar el tiempo hasta la progresión (ThP), el tiempo hasta la respuesta (bien RC o remisión parcial), el tiempo hasta la mejor respuesta y el tiempo hasta la RC. Evaluar biomarcadores séricos como las concentraciones de CD30 soluble (CD30s), interleucina 6 (IL-6) y quimiocina del timo y de activación regulada (TARC), que pueden estar asociadas con el resultado clínico. Evaluar la resolución de los síntomas B. Evaluar los datos relativos a la utilización de servicios sanitarios recogidos en el cuestionario de utilización de servicios sanitarios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated at the end of trial visit.
    Los objetivos secundarios se evaluarán en la visita de fin de estudio.
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Serum Biomarkers
    Inmunogenicidad, biomarcadores séricos.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial1
    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 EEA12
    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
    Czech Republic
    Germany
    Malaysia
    Poland
    Spain
    Thailand
    Turkey
    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
    LVLS
    última visita, último paciente.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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 different from the expected normal treatment of the condition
    El tratamiento normal esperado para esta enfermedad.
    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 Decision2013-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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