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    Summary
    EudraCT Number:2011-001240-29
    Sponsor's Protocol Code Number:C25002
    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:2012-04-26
    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 number2011-001240-29
    A.3Full title of the trial
    A Phase 1/2 Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    Estudio de fase 1/2 para evaluar el brentuximab vedotin (SGN-35) en pacientes pediátricos con linfoma anaplásico sistémico de células grandes o linfoma de Hodgkin recidivantes o refractarios.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Brentuximab Vedotin in Children and Adolescents With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    Estudio de Brentuximab Vedotin en niños y adolescentes con linfoma anaplásico sistémico de células grandes o linfoma de Hodgkin recidivantes o refractarios.
    A.4.1Sponsor's protocol code numberC25002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/59/2011
    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 Center
    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, MA
    B.5.3.3Post code02139
    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 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 nameBrentuximab vedotin
    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.3.10 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 Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    Linfoma anaplásico sistémico de células grandes o linfoma de Hodgkin recidivantes o refractarios
    E.1.1.1Medical condition in easily understood language
    Rare blood cancer requiring treatment
    Cáncer hematológico raro que requiere tratamiento
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065864
    E.1.2Term Anaplastic large-cell lymphoma, primary systemic type
    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
    Phase 1:
    ?To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin
    ?To assess the pharmacokinetics of brentuximab vedotin

    Phase 2:
    ?To determine the overall response rate (complete remission, partial remission) with brentuximab vedotin at the recommended phase 2 dose
    Fase 1
    ?Evaluar el perfil de seguridad y determinar la dosis máxima tolerada y/o la dosis recomendada de brentuximab vedotin para la fase 2 en pacientes pediátricos.
    ?Evaluar la farmacocinética de brentuximab vedotin.

    Fase 2
    ?Determinar la tasa global de respuesta (remisión completa, remisión parcial) cuando se administra la dosis recomendada para la fase 2 de brentuximab vedotin.
    E.2.2Secondary objectives of the trial
    Phase 1:
    ?To determine the immunogenicity of brentuximab vedotin
    ?To determine the overall response rate (complete remission, partial remission) with brentuximab vedotin
    ?To determine the time to progression, time to response, duration of response, and event-free, progression-free, and overall survival with brentuximab vedotin

    Phase 2:
    ?To determine the time to progression, time to response, duration of response, and event-free, progression-free, and overall survival with brentuximab vedotin
    ?To assess the pharmacokinetics and safety profile of brentuximab vedotin
    ?To determine the immunogenicity of brentuximab vedotin
    Fase 1
    ?Determinar la inmunogenia de brentuximab vedotin.
    ?Determinar la tasa global de respuesta (remisión completa, remisión parcial) con brentuximab vedotin.
    ?Determinar el tiempo hasta la progresión, el tiempo hasta la respuesta, la duración de la respuesta, la supervivencia sin episodios, la supervivencia sin progresión y la supervivencia global con brentuximab vedotin.

    Fase 2
    ?Determinar el tiempo hasta la progresión, el tiempo hasta la respuesta, la duración de la respuesta, la supervivencia sin episodios, la supervivencia sin progresión y la supervivencia global con brentuximab vedotin.
    ?Evaluar la farmacocinética y el perfil de seguridad de brentuximab vedotin.
    ?Determinar la inmunogenia de brentuximab vedotin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 2 to < 18 years (5 to < 18 years for patients with HL).
    2. Have a diagnosis of systemic anaplastic large-cell lymphoma, or Hodgkin lymphoma for which standard, curative, life-prolonging, or palliative treatment does not exist or is no longer effective. (Patients diagnosed with any relapsed or refractory CD30+ hematological malignancy [eg, primary mediastinal B-cell lymphoma] may be included in phase 1 of the study.)
    3. Patients with sALCL must have documented anaplastic lymphoma kinase (ALK) status.
    4. Patients with HL must be in their second or later relapse, have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy, and were ineligible for, refused, or previously received a stem cell transplant.
    5. Patients with relapsed or refractory sALCL must be beyond first remission or refractory to front-line chemotherapy.
    6. Performance score ? 60 from Lansky Play Performance Scale if ? 16 years
    7.Female patients who are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
    8.Male patients, even if surgically sterile, who agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
    9.Voluntary written consent (and institution-specific assent as appropriate based upon patient comprehension) must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent/assent may be withdrawn by the patient or patient guardian at any time without prejudice to future medical care.
    10.Suitable venous access for the study-required procedures.
    11.Clinical laboratory values as specified below within 14 days before the first dose of study drug:
    -Absolute neutrophil count greater than or equal to 1,500/?L.
    -Platelet count greater than or equal to 75,000/?L.
    -Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).
    -Serum creatinine less than or equal to 1.5 x ULN.
    -Alanine aminotransferase (ALT or SGPT) and aspartate aminotransferase (AST or SGOT) less than or equal to 2.5 x ULN.
    12.Patients must have a radiographically or clinically evaluable tumor per the IWG(1) criteria
    1.Pacientes de ambos sexos, de edades comprendidas entre 2 y < 18 años (5 y < 18 años en aquellos pacientes con LH).
    2.Diagnóstico de linfoma anaplásico sistémico de células grandes o linfoma de Hodgkin para los que no exista ningún tratamiento de referencia, curativo, paliativo o que prolongue la supervivencia, o en los que el tratamiento ya no sea eficaz. (Los pacientes diagnosticados con algún tipo de neoplasia hematológica CD30+ recidivante o refractaria [por ejemplo, linfoma mediastínico primario de células B] podrán incluirse en la fase 1 del estudio).
    3.En los pacientes con LAsCG deberá haberse documentado si expresan la cinasa de linfoma anaplásico (ALK).
    4.Los pacientes con LH no deberán haber respondido a un tratamiento quimioterápico sistémico (bien a un tratamiento de inducción para un estado avanzado de la enfermedad, o a un tratamiento de rescate), y no poder o no querer recibir, o haber recibido previamente un trasplante de células madre.
    5.Los pacientes con LAsCG recidivante o refractario deben haber experimentado una primera recidiva de la enfermedad o no responder al tratamiento quimioterápico de primera línea.
    6.Puntuación de actividad ? 60 en la Escala de Actividad y Juego de Lansky si el paciente tiene ? 16 años.
    7.Las pacientes en edad fértil deberán comprometerse a utilizar 2 métodos anticonceptivos eficaces, de forma simultánea, desde la firma del documento de consentimiento informado (ICF) hasta 6 meses después de la última dosis del fármaco del estudio, o abstenerse de mantener relaciones heterosexuales.
    8.Los pacientes masculinos (incluso aquellos estériles mediante un método quirúrgico) deberán comprometerse a utilizar un método de barrera eficaz durante la totalidad del período de tratamiento del estudio y los 6 meses posteriores a la última dosis del fármaco del estudio, o abstenerse de mantener relaciones heterosexuales.
    9.El paciente deberá otorgarse su consentimiento por escrito (así como cualquier asentimiento específico de la institución, según corresponda, dependiendo del grado de comprensión del paciente), de forma voluntaria, antes de que se lleve a cabo alguno de los procedimientos del estudio, que no formen parte de la atención médica habitual. Se hará saber al paciente que tanto él/ella como su representante legal podrán retirar dicho consentimiento/asentimiento en cualquier momento, sin perjuicio de la atención médica que pueda recibir posteriormente.
    10.Presentar un acceso venoso adecuado para que puedan realizarse los procedimientos específicos del estudio.
    11.Deberán presentar los siguientes valores en las diferentes pruebas analíticas, que deberán realizarse en el transcurso de los 14 días previos a la primera dosis del fármaco del estudio:
    -Recuento absoluto de neutrófilos ? 1.500/?l.
    -Recuento de plaquetas ? 75.000/?l.
    -Concentración sérica de bilirrubina ? 1,5 veces el límite superior de la normalidad (LSN).
    -Concentración sérica de creatinina ? 1,5 veces el LSN.
    -Concentración de alanina aminotransferasa (ALT o SGPT) y aspartato aminotransferasa (AST o SGOT) ? 2,5 veces el LSN.
    12.Presentar tumor clínica o radiológicamente evaluable, de acuerdo con los criterios del IWG (1).
    E.4Principal exclusion criteria
    1. Current diagnosis of primary cutaneous ALCL (those with systemic ALCL are eligible).
    2. Received an allogeneic stem cell transplant <6 months prior to first dose of study medication, or presence of polymerase chain reaction (PCR)-detectable CMV in any post-allogeneic transplant patient. (Prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to first dose of study drug.)
    3. Receiving immunosuppressive therapy.
    4. Receiving systemic therapy for chronic graft-versus-host disease (topical therapy is allowed).
    5. Previous treatment with any anti-CD30 antibody.
    6. Therapeutic monoclonal antibody use within the longer of 6 weeks or 5 plasma half-lives.
    7. Symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias, if this would, in the opinion of the investigator or medical monitor, interfere with assessment of efficacy or safety of the drug.
    8. History of another primary malignancy not in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear).
    9.Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
    10.History of cirrhosis.
    11.Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral therapy or antifungal therapy within 2 weeks prior to first dose of study drug (routine antimicrobial prophylaxis is acceptable).
    12.Concurrent therapy with other anti-neoplastic or experimental agents.
    13.Systemic corticosteroid therapy < 14 days prior to first dose of study medication.
    14.Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair the patient?s ability to receive or tolerate the planned treatment.
    15.Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
    16.Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks prior to first study dose.
    17.Prior autologous hematopoietic stem cell infusion < 6 weeks prior to first study dose.
    18.Grade 2 or greater unresolved toxicity from prior antineoplastic therapy.
    19.Received a strong inhibitor of CYP3A4 < 2 weeks prior to first study dose. 20.Grade 2 or greater peripheral neuropathy.
    21.Female patients who are both lactating and breastfeeding, or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of study drug.
    22.Received local palliative radiation therapy < 14 days prior to the first dose of study medication.
    23.Received radiation therapy to more than 25% of the bone marrow-containing spaces < 84 days prior to first dose of study medication.
    1.Diagnóstico actual de LACG cutáneo primario (los pacientes con LACG sistémico se considerarán idóneos para su inclusión en el estudio).
    2.Haber recibido un alotrasplante de células madre < 6 meses antes de la primera dosis del fármaco del estudio, o que se constate la presencia de CMV (basándose en los resultados de la reacción en cadena de la polimerasa [PCR]) tras haber recibido un alotrasplante. (En caso de que los resultados de una PCR anterior hubieran sido positivos podrá incluirse al paciente, siempre que el tratamiento hubiera sido exitoso y que los resultados de la PCR basal, previa a la primera dosis del fármaco del estudio, sean negativos).
    3.Estar recibiendo tratamiento inmunodepresor.
    4.Estar recibiendo tratamiento sistémico para enfermedad injerto-contra-huésped de carácter crónico (se permiten los tratamientos tópicos).
    5.Haber recibido un tratamiento previo con cualquier tipo de anticuerpo anti-CD30.
    6.Haber recibido anticuerpos monoclonales durante 6 semanas o 5 semividas plasmáticas (lo que sea mayor).
    7.Presentar una cardiopatía sintomática, entre otras, disfunción ventricular, arteriopatía coronaria o arritmias que, de acuerdo con la opinión del investigador o el monitor médico, puedan interferir con la evaluación de la eficacia o la seguridad del fármaco.
    8.Antecedentes de otra neoplasia primaria que no haya estado 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 cuello uterino in situ o lesiones intraepiteliales escamosas [de acuerdo con los resultados de un frotis de Pap])
    9.Enfermedad cerebral/meníngea activa y conocida, incluidos los signos o síntomas de leucoencefalopatía multifocal progresiva (LMP).
    10.Antecedentes de cirrosis.
    11.Infección fúngica, bacteriana o vírica sistémica y activa, que requiera tratamiento antimicrobiano, antivírico o antifúngico, en el transcurso de las 2 semanas previas a la primera dosis del fármaco del estudio (se permite la administración de profilaxis antimicrobiana habitual).
    12.Administración simultánea de otros fármacos antineoplásicos o experimentales.
    13.Haber recibido tratamiento sistémico con corticoesteroides < 14 días antes de la primera dosis de la medicación del estudio.
    14.Presentar cualquier enfermedad médica subyacente grave que, en opinión del investigador o el monitor médico, impida que el paciente reciba o tolere el tratamiento previsto.
    15.Hipersensibilidad conocida a proteínas recombinantes, proteínas murinas o a cualquier excipiente incluido en la formulación del fármaco.
    16.Haber recibido mostaza de nitrógeno, melfalán o tratamiento con BCNU, en el transcurso de las 6 semanas previas a la primera dosis del fármaco del estudio.
    17.Haber recibido un autotrasplante de células madre hematopoyéticas (infusión) < 6 semanas antes de la primera dosis del fármaco del estudio.
    18.Presentar una toxicidad de grado mayor o igual a 2, que no se haya resuelto, derivada de un tratamiento antineoplásico previo.
    19.Haber recibido un inhibidor potente de CYP3A4 < 2 semanas antes de la primera dosis del fármaco del estudio.
    20.Neuropatía periférica de grado mayor o igual 2.
    21.Pacientes que estén en período de lactancia o hayan presentado un resultado positivo en una prueba de embarazo en suero realizada durante el período de selección, o en una prueba de embarazo en orina que se haya realizado el día 1, antes de la administración de la primera dosis del fármaco del estudio.
    22.Haber recibido radioterapia local paliativa < 14 días antes de la administración de la primera dosis del fármaco del estudio.
    23.Haber recibido radioterapia en más del 25% de los espacios que contengan médula ósea < 84 días antes de la administración de la primera dosis del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 Primary Endpoints:
    -Adverse events (AEs), serious adverse events (SAEs), assessments of clinical laboratory values, and vital sign measurements
    - Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and MMAE

    Phase 2 Primary Endpoints:
    The primary endpoints in phase 2 include:
    - Overall response rate (CR, PR) as determined by an IRF using PET, CT, and clinical assessment according to IWG revised response criteria
    Criterios principales de valoración de la fase 1:
    -Acontecimientos adversos (AA), acontecimientos adversos graves (AAG), evaluaciones de los valores de los análisis clínicos y constantes vitales.
    -Concentraciones plasmáticas de brentuximab vedotin, anticuerpos terapéuticos totales y MMAE.

    Criterios principales de valoración de la fase 2:
    Los criterios principales de valoración de la fase 2 incluyen:
    -Tasa global de respuesta (RC, RP), determinada por el CRI mediante PET, TC, RMN y evaluación clínica, de acuerdo con los criterios de respuesta revisados del IWG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Does not have a specific timepoint.
    No tiene un momento de evaluación específico.
    E.5.2Secondary end point(s)
    Phase 1 Secondary Endpoints:
    -Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer
    -Overall response rate (CR, PR) as determined by an independent review facility (IRF) using positron emission tomography (PET), computed tomography (CT), magnetic resonance imaging (MRI), and clinical assessment, according to International Working Group (IWG) revised response criteria.
    -Time to progression
    -Time to response
    -Duration of response
    -Event-free survival
    -Progression-free survival
    -Overall survival

    Phase 2 Secondary Endpoints:
    -Time to progression
    -Time to response
    -Duration of response
    -Event-free survival
    -Progression-free survival
    -Overall survival
    -Adverse events, serious adverse events, assessments of clinical laboratory values, and vital sign measurements
    -Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and MMAE
    -Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer
    Criterios secundarios de valoración de la fase 1:
    -Título de anticuerpos anti terapéuticos (AAT) y título de AAT neutralizantes.
    -Tasa global de respuesta (RC, RP), determinada por un comité de revisión independiente (CRI), mediante tomografía por emisión de positrones (PET), tomografía computarizada (TC), resonancia magnética nuclear (RMN) y evaluación clínica, de acuerdo con los criterios de respuesta revisados del Grupo Internacional de Trabajo (IWG).
    -Tiempo hasta la progresión.
    -Tiempo hasta la respuesta.
    -Duración de la respuesta.
    -Supervivencia sin episodios.
    -Supervivencia sin progresión.
    -Supervivencia global.

    Criterios secundarios de valoración de la fase 2:
    -Tiempo hasta la progresión.
    -Tiempo hasta la respuesta.
    -Duración de la respuesta.
    -Supervivencia sin episodios.
    -Supervivencia sin progresión.
    -Supervivencia global.
    -Acontecimientos adversos (AA), acontecimientos adversos graves (AAG), evaluaciones de los valores de los análisis clínicos y constantes vitales.
    -Concentraciones plasmáticas de brentuximab vedotin, anticuerpos terapéuticos totales y MMAE.
    -Título de anticuerpos anti terapéuticos (AAT) y título de AAT neutralizantes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Does not have a specific timepoint.
    No tiene un momento de evaluación específico.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    Immunogenicity and biomarker analysis
    Immunogenia y análisis de biomarcadores
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pediatric dose-finding
    Búsqueda de dosis pediátrica
    E.7.2Therapeutic exploratory (Phase II) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    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
    Last visit of the last subject
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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 Yes
    F.1.1Number of subjects for this age range: 42
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Ensure each patient?s parents/legal guardian provides signed and dated informed consent before conducting any study specific procedure
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 42
    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.
    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 Decision2012-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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