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    EudraCT Number:2012-004128-39
    Sponsor's Protocol Code Number:C25006
    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:2013-10-02
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-004128-39
    A.3Full title of the trial
    A Phase 4, Open?label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
    Estudio de fase 4, abierto, con un único grupo de tratamiento, para evaluar brentuximab vedotin en pacientes con linfoma anaplásico sistémico de células grandes en recaída o refractario
    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 Systemic Anaplastic Large Cell Lymphoma
    Estudio de fase 4, abierto, con un único grupo de tratamiento, para evaluar brentuximab vedotin en pacientes con linfoma anaplásico sistémico de células grandes en recaída o refractario
    A.4.1Sponsor's protocol code numberC25006
    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
    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. name ADCETRIS
    D. 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Linfoma anaplásico sistémico de células grandes 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 14.1
    E.1.2Level HLT
    E.1.2Classification code 10002235
    E.1.2Term Anaplastic large cell lymphomas T- and null-cell types
    E.1.2System Organ Class 100000004851
    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 of single-agent brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate (ORR) in
    patients with relapsed or refractory sALCL following at least 1 multiagent chemotherapy (CHOP or equivalent multiagent chemotherapy regimens with curative intent)
    Evaluar la eficacia antineoplásica de brentuximab vedotin en monoterapia (1,8 mg/kg administrados por vía intravenosa cada 3 semanas), de acuerdo con la tasa global de respuestas objetivas (TRO), en pacientes con LAsCG en recaída o refractario, tras la administración de al menos 1 tratamiento poliquimioterápico (CHOP o un tratamiento poliquimioterápico equivalente, con intención curativa).
    E.2.2Secondary objectives of the trial
    To determine duration of tumor control, including duration of response, progression-free survival, and complete remission rate with brentuximab vedotin.
    To determine the percentage of patients receiving hematopoietic stem cell transplant (either autologous or allogeneic) after brentuximab vedotin therapy.
    To determine overall survival with brentuximab vedotin.
    To assess the safety and tolerability of brentuximab vedotin.
    To assess the pharmacokinetics of brentuximab vedotin.
    To determine the immunogenicity of brentuximab vedotin.
    Determinar la duración del control tumoral, incluida la duración de la respuesta, la supervivencia sin progresión (SSP) y la tasa de remisión completa (RC) con brentuximab vedotin. Determinar la proporción de pacientes que reciban trasplantes de hemocitoblastos (bien autotrasplante o alotrasplante) tras el tratamiento con brentuximab vedotin. Determinar la supervivencia global (SG) con brentuximab vedotin. Evaluar la seguridad y tolerabilidad de brentuximab vedotin. Evaluar la farmacocinética de brentuximab vedotin. Determinar la inmunogenia de brentuximab vedotin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy (CHOP or equivalent multiagent chemotherapy regimen with curative intent).
    - Histologically-confirmed sALCL based on local pathology report. If archived tissue cannot be obtained, a biopsy should be performed at screening.
    - Age greater than or equal to 18 years.
    - Patients must have bidimensional measurable disease of ? 1.5 cm as documented by radiographic technique (spiral CT preferred) per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
    - Pacientes con LAsCG en recaída o refractario, que hayan recibido previamente al menos 1 tratamiento poliquimioterápico (CHOP o un tratamiento poliquimioterápico equivalente, con intención curativa).
    - LAsCG confirmado histológicamente, de acuerdo con el informe patológico local.
    - Edad ? 18 años.
    - Los pacientes deberán presentar enfermedad bidimensional mensurable de ? 1,5 cm, y ello deberá haberse 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.
    E.4Principal exclusion criteria
    1. Previous treatment with brentuximab vedotin.
    2. Previously received an allogeneic transplant.
    3. Patients with current diagnosis of primary cutaneous ALCL (patients whose ALCL has transformed to sALCL are eligible).
    4. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
    ? Myocardial infarction within 6 months before the first dose of
    study drug
    ? New York Heart Association (NYHA) Class III or IV heart failure
    (Refer to Section 15.2).
    ? Evidence of current uncontrolled cardiovascular conditions,
    including cardiac arrhythmias, congestive heart failure (CHF),
    angina, or electrocardiographic evidence of acute ischemia or
    active conduction system abnormalities
    5. History of another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limits: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.
    6. Any active uncontrolled systemic viral, bacterial, or fungal infection
    7. Any antimicrobial, antiviral, or antifungal therapy within 1 week prior to the first dose of brentuximab vedotin (routine prophylaxis is acceptable)
    8. Treatment with any investigational products within 4 weeks before the first dose of study drug
    9. Current therapy with other systemic anti-neoplastic or investigational agents.
    10. Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
    11. Female patients who are lactating and breastfeeding or have a positive serum or urine pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug.
    12. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
    13. Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
    14. Known human immunodeficiency virus (HIV) positive.
    15. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
    1. Tratamiento previo con brentuximab vedotin.
    2. Haber recibido previamente un alotrasplante.
    3. Pacientes con diagnóstico actual de LACG cutáneo primario (los pacientes cuyo LACG se haya transformado en LAsCG se considerarán idóneos).
    4. 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: Infarto de miocardio en el transcurso de los 6 meses previos a 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 15.2). 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 o alteraciones activas del sistema de conducción.
    5. 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).
    6. Cualquier infección sistémica activa sin controlar (fúngica, bacteriana, vírica).
    7. Cualquier tratamiento antimicrobiano, antivírico o antifúngico, en el transcurso de la semana previa a la primera dosis de brentuximab vedotin (se acepta la administración de un tratamiento profiláctico rutinario).
    8. Tratamiento con cualquier producto en fase de investigación, en el transcurso de las 4 semanas previas a la primera dosis del fármaco del estudio.
    9. Tratamiento actual con otros fármacos antineoplásicos sistémicos o con fármacos en fase de investigación.
    10. Enfermedad cerebral/meníngea, incluidos los signos o síntomas de leucoencefalopatía multifocal progresiva (LMP).
    11. Pacientes que estén en período de lactancia o hayan presentado un resultado positivo en una prueba de embarazo en suero u orina realizada durante el período de selección, o en una prueba de embarazo que se haya realizado el día 1, antes de la administración de la primera dosis del fármaco del estudio.
    12. Pacientes con demencia o un estado mental alterado, que les impediría comprender y proporcionar el consentimiento informado.
    13. Hipersensibilidad conocida a proteínas recombinantes, proteínas murinas o a cualquier excipiente incluido en la formulación del fármaco.
    14. Presentar infección por el virus de la inmunodeficiencia humana (VIH).
    15. Presentar resultados positivos para el antígeno de superficie de la hepatitis B o infección activa por hepatitis C (conocida o sospechada).
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) per independent review facility
    El criterio principal de valoración fue la tasa de respuesta objetiva (TRO), de acuerdo con el criterio de un comité 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 última dosis del fármaco del estudio o la primera progresión de la enfermedad, muerte o cierre del estudio, lo que ocurra antes. Los datos de supervivencia total se recogerán cada 3 meses desde el fin de estudio durante 18 meses, y después cada 6 meses hasta la muerte o el cierre del estudio, lo que ocurra antes.
    E.5.2Secondary end point(s)
    - Duration of response per IRF
    - Progression-free survival (PFS) per IRF
    - Complete remission (CR) rate per IRF
    - Percentage of patients receiving hematopoietic stem cell transplant (SCT) following treatment with brentuximab vedotin
    - Overall survival (OS)
    - Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities
    - Selected pharmacokinetic parameters
    - The presence of anti-therapeutic antibodies (ATA) to brentuximab vedotin
    - Duración de la repuesta según el CI
    - Supervivencia libre de progresión según el CI
    - Porcentaje de pacientes que reciben trasplante de células hematopoyéticas seguidas de tratamiento con brentuximab vedotin.
    - Supervivencia total
    - Tipo, incidencia, gravedad, seriedad, y relación de los acontecimientos adversos, y anonrmalidades de laboratorio.
    - Parámetros seleccionados de farmacocinética.
    - La presencia de anticuerpos contra brentuximab vedotin.
    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. 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 concerned15
    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
    Czech Republic
    Russian Federation
    South Africa
    United Kingdom
    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
    ültima visita útilmo 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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 45
    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 la 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 Decision2013-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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