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    Summary
    EudraCT Number:2019-002746-21
    Sponsor's Protocol Code Number:GELTAMO18-HL
    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:2020-02-06
    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 number2019-002746-21
    A.3Full title of the trial
    A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin’s Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy
    Estudio Fase IIb, Aleatorizado, Para Evaluar la Eficacia de la Terapia de Rescate con Brentuximab Vedotin-ESHAP vs ESHAP en Pacientes con Linfoma de Hodgkin Clásico Refractario o en Recaída, Seguido de Consolidación con Brentuximab Vedotin (en lugar de Trasplante Autólogo de Células Madre Hematopoyéticas) en Aquellos Pacientes que Alcancen Respuesta Metabólica Completa Tras la Terapia de Rescate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with ESHAP vs
    Randomized study to evaluate the efficacy of therapy with Brentuximab
    Vedotin-Etoposide, Methylprednisolone, Cisplatin and Cytarabine (ESHAP)
    vs ESHAP in patients with Hodgkin's Lymphoma, followed by treatment
    with Brentuximab Vedotin in patients who reach metabolic response after
    salvage therapy
    Estudio aleatorizado para evaluar la eficacia de la terapia con Brentuximab Vedotin -Etopsido, Metilprednisolona, Cisplatino y Citarabina (ESHAP) vs ESHAP en pacientes con Linfoma de Hodgkin, seguido de tratamiento con Brentuximab Vedotin en pacientes que alcancen respuesta metablica tras la terapia de rescate
    A.3.2Name or abbreviated title of the trial where available
    BRESELIBET
    BRESELIBET
    A.4.1Sponsor's protocol code numberGELTAMO18-HL
    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 SponsorFundación GELTAMO
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrupo Español de linfomas y trasplante autologo de medula osea (GELTAMO)
    B.5.2Functional name of contact pointUnidad de ensayos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Aravaca nº 12 1º B
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491 319 57 80
    B.5.5Fax number+3491 391 33 83
    B.5.6E-mailensayosclinicos01@geltamo.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 Pharma
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder 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.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB189192
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Patients with Relapsed /Refractory Classical Hodgkin's Lymphoma
    Pacientes con Linfoma de Hodgkin Clásico Refractario o en Recaída
    E.1.1.1Medical condition in easily understood language
    Hodgkin’s Lymphoma
    Linfoma de Hodgkin
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080208
    E.1.2Term Classical Hodgkin lymphoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin’s Lymphoma in terms of primary efficacy endpoints.
    Evaluar la eficacia de la terapia de rescata con Brentuximab Vedotina-ESHAP frente a ESHAP en pacientes con Linfoma de Hodgkin Clásico Refractario o en Recaída en los términos que establece la variable primaria de eficacia
    E.2.2Secondary objectives of the trial
    1.To assess 2-year progression free survival (PFS) and 2-year overall
    survival (OS) in patients attaining a mCR and treated with BV
    consolidation
    2.To evaluate duration of response and time to progression in patients
    treated with BV consolidation after attaining a mCR
    3.To assess differences in toxicities between ESHAP-BV vs ESHAP
    4.To quantify stem cell collection yield
    5.To assess impact of second line therapy on 2-year PFS
    6.To compare the outcome of patients that attained less than mCR
    assessing their ORR and CR rates after autoHCT, time to next therapy
    (TTNT) and OS
    7.To assess TTNT2
    8.To evaluate the prognostic impact of a negative baseline PET-CT on PFS and OS
    9.To evaluate the prognostic impact of metabolic tumor volume in PFS and OS
    10.To determine short-term and mid-term toxicity
    11.To assess quality of life of patients
    12.To predict the risk to develop peripheral neuropathy
    13.To explore the concordance between PEC-TC local and central
    evaluation
    1.Evaluar la SLP y SG a los 2 años en pacientes con RCm y consolidación con BV
    2.Evaluar la duración de la respuesta y TTP en pacientes con RCm y consolidación con BV
    3.Evaluar las diferencias de toxicidad entre ESHAP-BV y ESHAP
    4.Cuantificar la recolección de células madre
    5.Evaluar el impacto de la segunda línea de tratamiento en la SLP a 2 años
    6.Comparar los resultados de pacientes que obtengan una respuesta inferior a RCm evaluando la tasa de RG y RC después de TAPH, TTNT y SG
    7.Evaluar la TTNT2
    8.Evaluar el impacto pronóstico de una PET-TAC basal negativa sobre la SLP y SG
    9.Evaluar el impacto pronóstico del volumen tumoral metabólico sobre la SLP y SG
    10.Determinar la toxicidad a corto y medio plazo
    11.Evaluar la calidad de vida de los pacientes
    12.Predecir el riesgo de desarrollar neuropatía periférica
    13.Explorar la concordancia entre la evaluación local y central de la PET-TAC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with classical HL CD30+ confirmed histologically (either at the time of diagnosis / at the time of first relapse) will be included in the trial. A biopsy at the time of relapse / demonstration of primary refractoriness is highly recommended. Patients diagnosed with 1st relapsed/refractory HL (treatment escalation or de-escalation, performed according to interim PET-CT result in first-line therapy, will still be considered as a single prior line, i.e., RATHL or LYSARC trials) will also be considered candidates for the trial. Each patient must meet all of the following inclusion criteria to be enrolled in the study:
    1.Male or female patients 18 years or older up to 65 years of age
    2.Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
    3.Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 highly effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
    4.Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
    5.ECOG performance status 0 to 2
    6.Measurable disease at time of enrolment (lymphadenopathy/ extranodal mass of at least 1.5 cm)
    7.No evidence of neuropathy grade ≥2
    8.Clinical laboratory values as specified below within 7 days before the first dose of study drug:
    • Absolute neutrophil count ≥ 1,500/µL unless there is known hematologic/solid tumor marrow involvement
    • Platelet count ≥ 75,000/ µL unless there is known marrow involvement of the disease
    • Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome.
    • ALT or AST must be < 3 x the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver
    • Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
    • Hemoglobin must be ≥ 8g/dL
    Pacientes con LH CD30+ clásico confirmado histológicamente (en el momento del diagnóstico o en el momento de la primera recidiva). Es muy recomendable realizar una biopsia en el momento de la recidiva o cuando se demuestre la presencia de resistencia primaria. Los pacientes diagnosticados de la primera recidiva o resistencia del LH (el aumento o la disminución escalonados del tratamiento en función del resultado del análisis intermedio de la PET-TC después del tratamiento de primera línea seguirán considerándose como una sola línea previa, es decir, ensayos RATHL o LYSARC) también se considerarán candidatos para participar en el ensayo. Los pacientes deberán cumplir todos los criterios de inclusión siguientes para poder participar en el estudio:
    1.Pacientes de ambos sexos con edades comprendidas entre los 18 y los 65 años.
    2.Obtención del consentimiento informado voluntario por escrito antes de realizar cualquier procedimiento relacionado con el estudio que no forme parte de la asistencia médica habitual, entendiéndose que el paciente podrá retirar su consentimiento en cualquier momento sin perjuicio para su futura asistencia médica.
    3.Las participantes de sexo femenino deberán ser posmenopáusicas desde al menos 1 año antes de la visita de selección, haber sido esterilizadas quirúrgicamente o, de encontrarse en edad fértil, comprometerse a utilizar 2 métodos anticonceptivos muy eficaces al mismo tiempo desde el momento de la firma del consentimiento informado hasta 6 meses después de la última dosis del fármaco del estudio o a abstenerse por completo de mantener relaciones heterosexuales.
    4.Los participantes varones, aunque se hayan sometido a esterilización quirúrgica (es decir, estado posterior a la vasectomía), deberán comprometerse a utilizar un método anticonceptivo de barrera eficaz durante todo el periodo del estudio y hasta 6 meses después de la última dosis del fármaco del estudio, o bien comprometerse a abstenerse por completo de mantener relaciones heterosexuales.
    5.Estado funcional del ECOG de 0 a 2.
    6.Enfermedad medible en el momento de la inclusión (linfadenopatía/masa extraganglionar de al menos 1,5 cm).
    7.Ausencia de signos de neuropatía de grado ≥2.
    8.Valores analíticos especificados a continuación en los 7 días previos a la primera dosis del fármaco del estudio:
    • Recuento absoluto de neutrófilos ≥1500/µl, a menos que exista una afectación medular conocida por un tumor hematológico o sólido.
    • Recuento de plaquetas ≥75 000/ µl a menos que exista afectación medular conocida.
    • Bilirrubina total <1,5 veces el límite superior de la normalidad (LSN) a menos que sea atribuible al síndrome de Gilbert.
    • ALT o AST <3 veces el límite superior del intervalo normal. La GOT y la GPT pueden encontrarse elevadas hasta 5 veces el LSN si esta elevación puede atribuirse razonablemente a la afectación hepática por tumores hematológicos/sólidos.
    • Creatinina sérica <2,0 mg/dL y/o aclaramiento de creatinina o aclaramiento de creatinina calculado >40 ml/minuto.
    • Hemoglobina ≥8 g/dl.
    E.4Principal exclusion criteria
    1.Lymphocyte predominant nodular Hodgkin’s lymphoma
    2.Prior treatment with brentuximab vedotin
    3.Female patient who is both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive 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 the protocol.
    5.Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
    Symptomatic neurologic disease compromising normal activities of daily living or requiring medic
    6.Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
    7.Known history of any of the following cardiovascular conditions
    • Myocardial infarction within 2 years of enrollment
    • New York Heart Association (NYHA) Class III or IV heart failure (see Appendix #9)65
    • 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
    • Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
    8.Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
    9.Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment
    10.Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
    11.Known human immunodeficiency virus (HIV) positive
    12.Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
    13.Focal radiation therapy within 30 days prior to study recruitment
    14.Major surgery within 28 days prior to randomization
    15.Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
    1.Linfoma de Hodgkin nodular con predominio linfocítico.
    2.Tratamiento previo con brentuximab vedotina.
    3.Mujeres que estén dando el pecho o con una prueba de embarazo en suero positiva durante el periodo de selección o una prueba de embarazo positiva el día 1 antes de recibir la primera dosis del fármaco del estudio.
    4.Cualquier trastorno médico o psiquiátrico grave que, en opinión del investigador, pueda interferir para completar ell tratamiento de acuerdo con el protocolo.
    5.Enfermedad cerebral o meníngea (LH o cualquier otra etiología) conocida, incluidos signos o síntomas de leucoencefalopatía multifocal progresiva (LMP).
    Enfermedad neurológica sintomática que comprometa las actividades normales de la vida diaria o que requiera tratamiento médico.
    6.Cualquier neuropatía periférica sensitiva o motora de grado 2 o superior.
    7.Antecedentes conocidos de cualquiera de los siguientes trastornos cardiovasculares:
    • Infarto de miocardio en los 2 años previos a la inclusión.
    • Insuficiencia cardíaca de clase III o IV de la New York Heart Association (NYHA) (véase el apéndice 9 del protocolo).
    • Signos de procesos cardiovasculares no controlados en la actualidad, como arritmias cardíacas, insuficiencia cardíaca congestiva (ICC), angina o signos electrocardiográficos de isquemia aguda o de anomalías activas del sistema de conducción.
    • Pruebas recientes (en los 6 meses previos a la primera dosis del fármaco del estudio) de una fracción de eyección ventricular izquierda <50 %.
    8.Cualquier infección vírica, bacteriana o fúngica sistémica activa que precise antibióticos sistémicos en las 2 semanas previas a la primera dosis del fármaco del estudio.
    9.Pacientes que hayan recibido un tratamiento previo con quimioterapia u otros fármacos en investigación sin que hayan transcurrido al menos 5 semividas (o 28 días si se desconocen las semividas) de la última dosis de ese tratamiento previo.
    10.Hipersensibilidad conocida a las proteínas recombinantes, proteínas murinas o cualquier excipiente contenido en la formulación de brentuximab vedotina.
    11.Positividad conocida para el virus de la inmunodeficiencia humana (VIH).
    12.Positividad para el antígeno de superficie del virus de la hepatitis B o certeza o sospecha de infección activa por el virus de la hepatitis C.
    13.Radioterapia focal en los 30 días previos a la inclusión en el estudio.
    14.Intervención de cirugía mayor en los 28 días previos a la aleatorización.
    15.Diagnóstico o tratamiento de otra neoplasia maligna en los 3 años previos a la primera dosis o diagnóstico previo de otra neoplasia maligna con signos de enfermedad residual. No se excluirá a los pacientes con cáncer de piel distinto del melanoma o carcinoma in situ en cualquier localización siempre que se hayan sometido a una resección completa.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment response based on Deauville scores 1, 2 (Complete metabolic response) at interim PET-CT
    Respuesta al tratamiento basado en la puntuación de Deauville 1, 2 (Respuesta metabólica completa) mediante PET-TAC
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the 3 first cycles of BV-ESHAP or ESHAP
    Después de 3 ciclos de tratamiento con BV-ESHAP o ESHAP
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    1- Progression Free Survival (PFS): time from entry onto the study until lymphoma progression or death as a result of any cause
    2- Overall Survival (OS): time from entry onto the clinical trial until death as a result of any cause.
    3- Duration of response (DOR): time from first documentation of CR or PR to disease progression or death from any cause, whichever occurs first
    4- Time to Progression (TTP): time from study entry until lymphoma progression or death as a result of lymphoma.
    5- Time to Next Treatment (TTNT): time from the end of primary treatment until the onset of the next therapy.
    6- Time to Next Treatment 2 (TTNT2): time from study enrollment to initiation of second line of therapy due to disease progression.
    7- Overall response rate, complete response rate
    8- Prognostic impact of metabolic tumor volume

    Patient reported outcomes:
    9- Quality of life of patients

    Secondary safety endpoints:
    10- Toxicity
    11- Peripheral neuropathy
    12- Stem cell collection yield
    Variables secundarias de eficacia:
    1- Supervivencia libre de progresión (SLP): tiempo desde la entrada en el estudio hasta la progresión del linfoma o muerte por cualquier causa.
    2-Supervivencia global (SG): tiempo desde la entrada en el estudio hasta la muerte por cualquier causa
    3-Duración de la respuesta: tiempo desde que se documente la primera RC o RP hasta la progresión de la enfermedad o muerte por cualquier causa, lo que ocurra primero
    4-Tiempo hasta la progresión (TTP): tiempo desde la entrada en el estudio hasta la progresión del linfoma o muerte por causa del linfoma
    5-Tiempo hasta el siguiente tratamiento (TTNT): tiempo desde la finalización del primer tratamiento hasta el inicio del siguiente tratamiento
    6-Tiempo hasta el siguiente tratamiento 2(TTNT2): tiempo desde la entrada en el estudio hasta el inicio de una segunda línea de tratamiento debido a progresión de la enfermedad
    7-Tasa de respuesta global (RG) y tasa de respuesta completa (RP)
    8-Impacto pronóstico del volumen tumoral metabólico

    Resultados reportados por los pacientes
    9- Calidad de vida de los pacientes

    Variables secundarias de seguridad:
    10-Toxicidad
    11-Neuropatía periférica
    12-Recolección de células madre
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy timepoints:
    1- Progression Free Survival: 2 years
    2- Overall Survival: 2 years
    3- Duration of response: throughout the study period
    4- Time to progression: throughout the study period
    5- Time to next treatment (TTNT): throughout the study period
    6- Time to next treatment 2 (TTNT2): throughout the study period
    7- Overall response rate, complete response rate: After the 3 first cycles of BV-ESHAP or ESHAP
    8- Prognostic impact of metabolic tumor volume: throughout the study period

    Patient reported outcomes:
    9- Quality of life: throughout the study period

    Secondary safety timepoints:
    10- Toxicity: throughout the study period
    11- Peripheral neuropathy: throughout the study period
    12- Stem cell collection yield: throughout the first 3 cycles of treatment
    Variables secundarias de eficacia:
    1- Supervivencia libre de progresión: 2 años
    2-Supervivencia global: 2 años
    3-Duración de la respuesta: durante el estudio
    4-Tiempo hasta la progresión: durante el estudio
    5-TTNT: durante el estudio
    6-TTNT2: durante el estudio
    7-Tasa de respuesta global y tasa de respuesta completa: después de 3 ciclos de tratamiento con BV-ESHAP o ESHAP
    8-Impacto pronóstico del volumen tumoral metabólico: durante el estudio

    Resultados reportados por los pacientes
    9- Calidad de vida de los pacientes: durante el estudio

    Variables secundarias de seguridad:
    10-Toxicidad: durante el estudio
    11-Neuropatía periférica: durante el estudio
    12-Recolección de células madre: durante los 3 primeros ciclos de tratamiento
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    3 ciclos de ESHAP seguidos de 16 ciclos con BV
    3 cycles of ESHAP followed by 16 cycles of BV
    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 concerned18
    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
    Austria
    Belgium
    Czech Republic
    Greece
    Israel
    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
    Last visit of the last patient
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state92
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 150
    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)
    Standard clinical practice
    Según la práctica clínica habitual
    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 Decision2020-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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