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    Summary
    EudraCT Number:2012-004766-17
    Sponsor's Protocol Code Number:0761-010
    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:2013-06-10
    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 number2012-004766-17
    A.3Full title of the trial
    Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma (CTCL)
    Ensayo abierto, multicéntrico y randomizado de comparación entre el anticuerpo monoclonal anti-CCR4 KW-
    0761 (Mogamulizumab) y Vorinostat en pacientes con linfoma cutáneo de células T tratado previamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test if KW-0761 (an antibody) or a chemotherapy drug, called vorinostat, will work in patients with recurrent or unsuccessfully treated Cutaneous T-Cell Lymphoma.
    Ensayo clínico para probar si KW-0761 (un anticuerpo) o un medicamento de quimioterapia, llamado vorinostat, trabajará en pacientes con recurrente o tratada sin éxito Linfoma Cutáneo de Células T.
    A.4.1Sponsor's protocol code number0761-010
    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 SponsorKyowa Hakko Kirin Pharma, 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 supportKyowa Hakko Kirin Pharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKyowa Hakko Kirin Pharma, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address212 Carnegie Center, Suite 101
    B.5.3.2Town/ cityPrinceton
    B.5.3.3Post codeNJ 08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16099191100
    B.5.5Fax number+16099191111
    B.5.6E-mailKW-0761@kyowa-kirin-pharma.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 POTELIGEO
    D.2.1.1.2Name of the Marketing Authorisation holderKyowa Hakko Kirin Co., Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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/3/11/943
    D.3 Description of the IMP
    D.3.1Product nameKW-0761 (Mogamulizumab)
    D.3.2Product code KW-0761
    D.3.4Pharmaceutical form Solution for injection
    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 INNmogamulizumab
    D.3.9.1CAS number 1159266-37-1
    D.3.9.2Current sponsor codeKW-0761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Zolinza
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Corp
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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/3/11/854
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvorinostat
    D.3.9.1CAS number 149647-78-9
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    Treatment of subjects with previously treated cutaneous T-cell lymphoma
    Tratamiento de pacientes con linfoma cutáneo de células T tratados previamente
    E.1.1.1Medical condition in easily understood language
    Treatment of a type of cancer affecting the skin and/or other parts of the body, that has failed to respond to other treatments
    Tratamiento de un tipo de cáncer que afecta a la piel y / o en otras partes del cuerpo, que no ha respondido a otros tratamientos
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10011679
    E.1.2Term Cutaneous T-cell lymphoma refractory
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory Cutaneous T-Cell Lymphoma (CTCL).
    Comparar la supervivencia sin progresión que se obtiene con KW-0761 con la que se obtiene con
    Vorinostat en pacientes con linfoma cutáneo de células T (CTCL) recidivante o refractario.
    E.2.2Secondary objectives of the trial
    ? To compare the overall response rate of KW-0761 versus vorinostat in subjects with relapsed or refractory CTCL;
    ? To evaluate and compare improvements in Quality of Life (QoL) measurements, Skindex-29, FACT-G, and EQ-5D-3L for subjects receiving KW-0761 versus vorinostat;
    ? To evaluate and compare improvements in the Pruritus Evaluation (Likert scale & Itchy QoL) for subjects receiving KW-0761 versus vorinostat;
    ? To estimate the duration of response for both the KW-0761 and vorinostat arms for those subjects with relapsed or refractory CTCL responding to treatment;
    ? To determine if subjects who relapse on vorinostat can achieve response upon cross over to treatment with KW-0761;
    ? To further assess the safety of KW-0761;
    ? To describe the immunogenicity of KW-0761.
    Comparar la tasa de respuesta global obtenida con KW-0761 con la obtenida con Vorinostat en pacientes
    con CTCL recidivante o refractario;
    ? Evaluar y comparar las mejoras en las mediciones de la calidad de vida y en los cuestionarios Skindex-29,
    FACT-G y EQ-5D-3L en pacientes tratados con KW-0761, en comparación con los tratados con Vorinostat;
    ? Evaluar y comparar las mejoras en la evaluación del picor (escala de Likert y Itchy QoL) de los pacientes
    tratados con KW-0761, en comparación con los tratados con Vorinostat;
    ? Calcular la duración de la respuesta en los grupos de KW-0761 y de Vorinostat en pacientes con CTCL
    recidivante o refractario que respondan al tratamiento;
    ? Determinar si los pacientes que presentan recidiva a pesar del tratamiento con Vorinostat pueden responder si se les cambia el tratamiento por KW-0761;
    ? Evaluar mejor la seguridad de KW-0761;
    ? Describir la inmunogenia de KW-0761.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Voluntarily signed and dated Institutional Review Board / Ethics Committee approved informed consent form in accordance with regulatory and institutional guidelines. Written informed consent must be obtained prior to performing any study-related procedure;
    2) Males and female subjects ? 18 years of age at the time of enrollment;
    3) Histologically confirmed diagnosis of MF or SS within 3 months of the Pre-treatment Visit;
    a. For SS (defined as meeting T4 plus B2 criteria), where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathologic features, the diagnosis may be based on either a node biopsy or fulfillment of B2 criteria including a clone in the blood that matches that of the skin.
    4) Stage IB, II-A, II-B, III and IV;
    5) Subjects who have progressed following at least one prior course of systemic therapy (e.g., interferon, denileukin diftitox, bexarotene, photopheresis, anti-neoplastic chemotherapy, etc.);
    6) Eastern Cooperative Oncology Group (ECOG) performance status score of ? 1 at study entry;
    7) The subject has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ? 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0) excluding the specifications required in 8, 9 and 10 below.
    8) Adequate hematological function:
    a. absolute neutrophil count (ANC) ? 1,500 cells/?L (? 1,500/mm3)
    b. platelets ? 100,000 cells/?L; (? 100,000/mm3)
    c. in subjects with known bone marrow involvement, ANC must be ? 1,000 cells/?L (? 1,000/mm3) and platelets ? 75,000 cells/?L. (? 75,000/mm3)
    9) Adequate hepatic function:
    a. bilirubin ? 1.5 times the specific institutional upper limit of normal (ULN), except for subjects with Gilbert?s syndrome;
    b. aspartate transaminase (AST) and alanine transaminase (ALT) each ? 2.5 x ULN or ? 5.0 x ULN in the presence of known hepatic malignancy.
    10) Adequate renal function:
    a. serum creatinine ? 1.5 x ULN;
    or
    b. calculated creatinine clearance > 50 mL/min using the Cockcroft-Gault formula.
    11) Subjects previously treated with anti-CD4 antibody or alemtuzumab are eligible provided their CD4+ cell counts are ? 200/mm3.
    12) Subjects with MF and a known history of non-complicated staphylococcus infection/colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics.
    13) Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication.
    14) WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea
    ? 12 consecutive months);
    15) Male subjects and their female partners of child bearing potential must be willing to use an appropriate method of contraception defined as oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose.
    1) Firma y fecha voluntarias del consentimiento informado aprobado por el CEIC, de conformidad con las
    normas administrativas y del centro. El consentimiento informado por escrito debe obtenerse antes de
    realizar cualquier procedimiento relacionado con el estudio.
    Edad y sexo
    2) Varones y mujeres de ³ 18 años de edad en el momento de la inclusión;
    Población diana
    3) Diagnóstico de MF o SS en los 3 meses previo a la visita pretratamiento, confirmado por histología;
    a. En el caso del SS (que debe cumplir los criterios T4 y B2) en los que la biopsia de la piel
    eritrodérmica no permita hacer un diagnóstico histológico, pero lleve a pensar en dicho
    diagnóstico, el diagnóstico deberá basarse en una biopsia ganglionar o en el cumplimiento de los
    criterios B2, incluyendo un clon en la sangre que coincida con el de la piel;
    4) Estadio IB, II-A, II-B, III y IV;
    5) Pacientes con progresión de la enfermedad tras recibir al menos un ciclo previo de tratamiento
    sistémico (p. ej., interferón, denileukina diftitox, bexaroteno, fotoféresis, quimioterapia antineoplásica,
    etc.);
    6) Puntuación del estado funcional del ECOG de ? 1 al entrar en el estudio;
    7) El paciente ha superado todos los efectos tóxicos clínicamente significativos del tratamiento contra el
    cáncer previo, que en la actualidad son de grado ? 1 según la versión 4.0 de los criterios terminológicos
    comunes para acontecimientos adversos del National Cancer Institute (NCI-CTCAE, v.4.0), excepto en
    los casos que se citan en los número 8, 9 y 10, más adelante.
    8) Función hematológica suficiente:
    a. Recuento absoluto de neutrófilos (RAN) ? 1.500 células/ml (? 1.500/mm3);
    b. plaquetas ³ 100 000 células/ml; (³ 100 000/mm3); y
    c. en pacientes con afectación de la médula ósea, el RAN debe ser? 1000 células/ml (? 1000/mm3) y
    las plaquetas ? 75 000 células/ml. (? 75 000/mm3).
    9) Función hepática suficiente:
    a. Bilirrubina ? 1,5 veces el límite superior de la normalidad (LSN) específico del centro, excepto
    para pacientes con síndrome de Gilbert; y
    b. aspartato transaminasa (ASAT) y alanina transaminasa (ALAT) ? 2,5 x LSN cada una, o ? 5,0 x
    LSN en presencia de cáncer de hígado.
    10) Función renal suficiente:
    a. Creatinina sérica ?1,5 x LSN;
    o
    b. aclaramiento de creatinina calculado >50 ml/min, utilizando la fórmula de Cockcroft-Gault.
    11) Podrán participar pacientes tratados previamente con un anticuerpo anti-CD4 o con Alemtuzumab,
    siempre que cuenten con > 200 células/mm3.
    12) Podrán participar pacientes con MF y antecedentes de infección o colonización estafilocócica no
    complicada, si siguen recibiendo dosis estables de antibióticos preventivos.
    13) Las mujeres en edad fértil (MEF) deberán dar resultado negativo en una prueba de embarazo efectuada
    en los 7 días previos a la administración del fármaco del estudio.
    14) Las MEF deberán comprometerse a utilizar un anticonceptivo eficaz, que pueden ser anticonceptivos
    orales, un método de doble barrera (preservativo con espermicida o diafragma con espermicida) o la
    abstinencia real de relaciones sexuales (la abstinencia periódica, p. ej., los métodos del calendario, de la
    ovulación, sintotérmico, de la postovulación y de la retirada no se aceptan como métodos
    anticonceptivos) durante el estudio y hasta 3 meses después de recibir la última administración. Las
    MEF son todas las mujeres que hayan pasado la menarquia, que no se hayan sometido a una
    esterilización satisfactoria por métodos quirúrgico y que no estén en la menopausia (que se define por
    amenorrea durante ?12 meses);
    15) Los pacientes de sexo masculino y sus parejas de sexo femenino que sean MEF deberán estar
    dispuestos a utilizar un anticonceptivo eficaz, que pueden ser anticonceptivos orales, un método de
    doble barrera (preservativo con espermicida o diafragma con espermicida) o la abstinencia real de
    relaciones sexuales (la abstinencia periódica, p. ej., los métodos del calendario, de la ovulación,
    sintotérmico, de la postovulación y de la retirada no se aceptan como métodos anticonceptivos) durante
    el estudio y hasta 3 meses después de recibir la última administración.
    E.4Principal exclusion criteria
    1) Large cell transformation of SS as well as transformed MF;
    2) Have had a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current prostate-specific antigen of < 0.1 ?g/mL (< 1 ng/mL), treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast with in the past two years may enroll as long as there is no current evidence of disease.
    3) Clinical evidence of central nervous system (CNS) metastasis.
    4) Psychiatric illness, disability or social situation that would compromise the subject?s safety or ability to provide consent, or limit compliance with study requirements.
    5) Significant uncontrolled intercurrent illness including, but not limited to:
    a. uncontrolled infection requiring antibiotics;
    b. clinically significant cardiac disease (class III or IV of the New York Heart Association classification);
    c. unstable angina pectoris;
    d. angioplasty, stenting, or myocardial infarction within 6 months;
    e. uncontrolled hypertension (systolic blood pressure (BP) > 160 mm Hg or diastolic BP
    > 100 mm Hg, found on two consecutive measurements separated by a 1-week period) despite two anti-hypertensive medications;
    f. clinically significant cardiac arrhythmia; or
    g. uncontrolled diabetes.
    6) Known or tests positive for human immunodeficiency virus, human T-cell leukemia virus, hepatitis B or hepatitis C.
    7) Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.
    8) Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
    9) Known active autoimmune disease will be excluded. (For example; Graves? disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn?s disease; psoriasis).
    10) Is pregnant (confirmed by beta human chorionic gonadotrophin [?-HCG]) or lactating.
    11) Prior treatment with KW-0761.
    12) Prior treatment with vorinostat.
    13) Have had any therapy directed against the subject?s underlying cancer or any investigational medications within four weeks of randomization (skin directed treatments, including topicals and radiation within two weeks of randomization). However, subjects with rapidly progressive malignant disease may be enrolled prior to this period after discussion with the Medical Monitor.
    14) Subjects on a stable dose of a low dose systemic corticosteroid (? 20 mg prednisone equivalent) for at least 4 weeks prior to study entry may continue use although the investigator should attempt to taper the use to the lowest dosage tolerable while on study. Initiation of treatment with systemic corticosteroids or increase in dose while on study is not permitted except to treat an infusion reaction. Subjects may receive intra-articular corticosteroid injections, intraocular corticosteriod drops, inhalation or nasal corticosteroids and replacement doses of systemic corticosteroids as needed.
    15) Subjects on a stable dose of medium or low potency topical corticosteroids for at least 4 weeks prior to study entry may continue use at the same dose, although the investigator should attempt to taper the use to the lowest dosage tolerable while on study. Initiation of treatment with topical corticosteroids while on study is not permitted except to treat an acute rash.
    16) History of allogeneic transplant.
    17) Autologous hematopoietic stem cell transplant within 90 days of study entry.
    18) Subjects on any immunomodulatory drug for concomitant or intercurrent conditions other than T-cell lymphoma or who have received any of these agents within 4 weeks of treatment, including but not limited to the following, will be excluded: low dose or oral methotrexate; azathioprine; intravenous
    (iv) immunoglobulin; low dose or oral cyclophosphamide; cyclosporine; mycophenolate; infliximab;etanercept; leflunomide; adalimumab; lenalidomide; abatacept; rituximab; anakinra; interferon-?; IL-2 and natalizumab.
    1) Transformación del SS en linfoma de células grandes y MF transformada.
    2) Haber presentado un trastorno maligno en los dos últimos años. No obstante, podrán participar los
    pacientes con cánceres cutáneos distintos del melanoma, melanoma in situ, cáncer localizado en la
    próstata con antígeno prostático específico de < 0,1 ?g/ml (< 1 ng/ml), cáncer de tiroides, carcinoma
    cervical in situ o carcinoma de mama ductal/lobular tratados en los dos últimos años, si no presentan
    indicios de enfermedad en la actualidad.
    3) Demostración clínica de metástasis en el sistema nervioso central (SNC).
    4) Enfermedad psiquiátrica, discapacidad o situación social que pueda comprometer la seguridad del
    paciente o su capacidad de otorgar el consentimiento, o limitar el cumplimiento de los requisitos del
    estudio.
    5) Enfermedad intercurrente significativa no controlada, como (entre otras):
    a. Infección no controlada que precisa antibióticos;
    b. cardiopatía clínicamente significativa (clases III o IV de la clasificación de la New York Heart
    Association);
    c. angina de pecho inestable;
    d. angioplastia, endoprótesis o infarto de miocardio en los 6 meses previos;
    e. hipertensión no controlada (presión arterial sistólica (PAS) > 160 mm Hg o diastólica (PAD)
    > 100 mm Hg en dos mediciones consecutivas con 1 semana de diferencia), a pesar de recibir dos
    antihipertensivos;
    f. arritmia cardíaca clínicamente significativa; o
    g. diabetes no controlada.
    6) Infección por el virus de la inmunodeficiencia humana, por el virus de la leucemia de células T humana
    o por los virus de las hepatitis B o C, con o sin confirmación mediante la prueba correspondiente.
    7) Infección activa por el virus del herpes simple o del herpes zóster. Podrán entrar en el estudio los
    pacientes que estén recibiendo profilaxis del herpes si han empezado a recibirla al menos 30 días antes
    de su entrada en el estudio y no presentan signos de infección activa, y quienes lleven más de 6 meses
    sin infección activa; durante el estudio deberán seguir tomando la medicación que se les haya recetado.
    8) Haber presentado reacciones alérgicas a los anticuerpos monoclonales o a otras proteínas terapéuticas.
    9) No podrán participar quienes presenten enfermedades autoinmunitarias activas. (Por ejemplo:
    enfermedad de Graves, lupus eritematosos sistémico, artritis reumatoide, enfermedad de Crohn o
    psoriasis).
    10) Embarazo (confirmado mediante gonadotropina coriónica humana beta [?-HCG]) o lactancia.
    Tratamientos o medicamentos prohibidos
    11) Tratamiento previo con KW-0761.
    12) Tratamiento previo con Vorinostat.
    13) Haber recibido tratamiento contra el cáncer del paciente o cualquier fármaco en investigación en las 4
    semanas previas a la randomización (tratamientos que actúan sobre la piel, como los que se administran
    por vía tópica y la radiación en las dos semanas previas a la randomización). No obstante, los
    pacientes con enfermedad maligna rápidamente progresiva se podrán incluir antes de este periodo,
    comentándolo antes con el monitor médico.
    14) Los pacientes que hayan recibido una dosis estable de una corticosteroide sistémico en dosis baja (? 20
    mg de equivalente de prednisona) en las 4 semanas previas a la entrada en el estudio, como mínimo,
    podrán seguir recibiéndola, aunque el investigador intentará reducir gradualmente la dosis hasta utilizar
    la dosis más baja que tolere el paciente durante el estudio. No se podrá iniciar el tratamiento con
    corticosteroides sistémicos ni aumentar su dosis durante el estudio, salvo para tratar una reacción a la
    infusión (véase el apartado 5.2.1.5.1). Los pacientes podrán recibir inyecciones intrarticulares de
    corticosteroides, colirios de corticosteroides, corticosteroides por vía inhalatoria o nasal y dosis de
    sustitución de corticosteroides sistémicos, en función de sus necesidades.
    15) Los pacientes que hayan recibido una dosis estable de una corticosteroide tópico de potencia media o
    baja en las 4 semanas previas a la entrada en el estudio. No se podrá iniciar un tratamiento con corticosteroides por vía tópica
    durante el estudio, salvo para tratar un exantema agudo.
    16) Antecedentes de trasplante alogénico.
    17) Autotrasplante de células madre hematopoyéticas en los 90 días previos a la entrada en el estudio.
    18) No podrán participar los pacientes que reciban cualquier fármaco inmunomodulador para otros
    trastornos concomitantes o intercurrentes distintos del linfoma de células T, o que hayan recibido
    cualquiera de los siguientes fármacos en las 4 semanas previas al tratamiento,: metotrexato
    azatioprina; inmunoglobulina por vía intravenosa (IV); ciclofosfamida en
    dosis baja o por vía oral; ciclosporina; micofenolato; infliximab; etanercept; leflunomida; adalimumab;
    lenalidomida; abatacept; rituximab; anakinra; interferón-?; IL-2 y natalizumab.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival.
    supervivencia sin progresión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression will be evaluated at days 26-28.
    La progresión se evaluara los dias 26-28.
    E.5.2Secondary end point(s)
    Overall response rate;
    Skindex-29;
    FACT-G;
    EQ-5D-3L.
    Tasa de respuesta global;
    Skindex-29;
    FACT-G;
    EQ-5D-3L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluated at days 26-28.
    Evaluado los dias 26-28.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA13
    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
    Denmark
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The study will continue until 255 total progression-free survival (PFS) events are observed or until a maximum of 24 months after the last randomized patient is dosed, whichever comes first.
    El estudio continuará hasta que se observen 255 eventos de supervivencia sin progresión (PFS totales) o hasta un máximo de 24 meses después de que se dosifique al último paciente aleatorizado, lo que ocurra primero.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 267
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 317
    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)
    Patients will revert back to their primary physician for further evaluation
    Los pacientes volverán a su médico de cabecera para una evaluación adicional
    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 Decision2013-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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