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    Summary
    EudraCT Number:2016-000259-28
    Sponsor's Protocol Code Number:54179060LYM3003
    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:2016-08-05
    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 number2016-000259-28
    A.3Full title of the trial
    A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma.
    Estudio aleatorizado, abierto, de seguridad y eficacia de ibrutinib en pacientes pediátricos y adultos jóvenes con Linfoma No Hodgkin de células maduras B en recaída o refractario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma
    Seguridad y eficacia de ibrutinib en pacientes pediátricos y adultos jóvenes con Linfoma No Hodgkin
    A.4.1Sponsor's protocol code number54179060LYM3003
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/252/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@its.jnj.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 Imbruvica
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/OD/116/13
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.2Product code JNJ-54179060
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codeJNJ-54179060
    D.3.9.3Other descriptive nameIBRUTINIB
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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.IMP: 2
    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 Imbruvica
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIbrutinib
    D.3.2Product code JNJ-54179060
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codeJNJ-54179060
    D.3.9.3Other descriptive nameIBRUTINIB
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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.IMP: 3
    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 imbruvica
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIbrutinib
    D.3.2Product code JNJ-54179060
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codeJNJ-54179060
    D.3.9.3Other descriptive nameIBRUTINIB
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    Mature B-Cell Neoplasm
    Neoplasma Células-B Maduras
    E.1.1.1Medical condition in easily understood language
    Mature B-Cell Cancer
    Cáncer Células-B Maduras
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1:
    Confirm that the pharmacokinetics in pediatric subjects is consistent with that in adults

    Part 2:
    Assess efficacy (EFS) of ibrutinib in combination with RICE or RVICI background therapy compared to RICE or RVICI background therapy alone
    Parte 1:
    Confirmar que la farmacocinética en los sujetos pediátricos es consistente con la de adultos

    Parte 2:
    • Evaluar la seguridad de ibrutinib combinado con (RICE) o (RVICI) como tratamiento de base en sujetos pediátricos con neoplasias malignas de células B
    E.2.2Secondary objectives of the trial
    Part 1:
    -Evaluate the safety and tolerability of ibrutinib in combination with RICE or RVICI background therapy in pediatric subjects with B-cell malignancies
    -Assess anti-tumor activity of ibrutinib as add-on to RICE or RVICI regimens
    -Assess disease-specific biomarkers
    -Assess the pharmacodynamic response
    -Acceptability and palatability assessment of all ibrutinib formulations

    Part 2:
    -Evaluate the safety and tolerability of ibrutinib in combination with RICE or RVICI background therapy in pediatric subjects and young adults with B-cell malignancies
    -Determine the ORR
    -Evaluate tumor volume reduction at Day 14
    -Determine the number and proportion of subjects who proceed to stem cell transplantation
    -Evaluate the time to response
    -Measure the duration of response
    -Evaluate long-term survival (EFS at 2 and 3 years)
    -Evaluate overall survival
    -Assess disease-specific biomarkers
    For the remaining secondary objectives, please refer to protocol page 28.
    P1: Evaluar
    -La seguridad y tolerabilidad de ibrutinib combinado con (RICE) o (RVICI) como tratamiento de base en sujetos pediátricos con neoplasias malignas de células B
    -La actividad antitumoral de ibrutinib como tratamiento complementario a los regímenes de RICE o RVICI
    -Los biomarcadores específicos de la enfermedad
    -La respuesta farmacodinámica
    - Valoración de la aceptabilidad y palatabilidad de todas las formulaciones de ibrutinib
    P2: Evaluar
    -La seguridad y tolerabilidad de ibrutinib combinado con tratamiento de base con RICE o RVICI en sujetos pediátricos y adultos jóvenes con neoplasias de linfocitos B
    -Determinar tasa respuesta global (TRG)
    -Reducción del volumen tumoral el Día 14
    -Determinar el número y proporción de sujetos que pasan a trasplante de células madre
    -El tiempo hasta la respuesta
    -Medir la duración de la respuesta
    -Supervivencia a largo plazo (SLE a 2 y 3 años)
    -Supervivencia global
    -Niomarcadores específicos de la neoplasia
    Otro, ref. Pág.28
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants with 1 to less than (<) 18 years of age (Part 1 only), or 1 to 30 years of age, inclusive, if initial diagnosis of mature B-cell non-Hodgkin lymphoma (NHL) occurred at <18 years of age (Part 2 only)
    - Participants must be in first or later recurrence or have disease that is primarily refractory to conventional therapy
    - Participants must have at least 1 of the following: 1 site of measurable disease greater than (>) 1 centimeter (cm) in the longest diameter by radiological imaging; bone marrow involvement; cerebrospinal fluid with blasts present
    - Participants with lansky-Karnofsky score of greater than or equal to (>=) 50
    - Adolescent women/young women of childbearing potential must have a negative highly sensitive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening before enrollment/randomization. Adolescent/young women who are pregnant or breastfeeding are ineligible for this study
    -Participantes de 1 a <18 años (Parte 1 solo), o de 1 a 30 años, inclusive, si el diagnóstico inicial de LNH de linfocitos B maduros fue antes de los 18 años (Parte 2 solo)

    -Participante debe estar en la primera recurrencia o posteriores o tener una neoplasia que sea intrínsecamente resistente al tratamiento convencional
    - Participante debe presentar al menos 1 de los siguientes:
    1) sitio de neoplasia mensurable >1 cm de diámetro mayor en una prueba de imagen radiológica
    2) Afectación de la médula ósea
    3)Blastos en el líquido cefalorraquídeo
    -Puntuación Lansky-Karnofsky de ≥50
    -Las mujeres adolescentes/jóvenes con posibilidad de concebir se realizarán una prueba de embarazo de  gonadotropina corinónica humana ( hCG) de alta sensibilidad en suero u orina que debe dar negativo en la Selección antes de la inclusión/aleatorización. Las mujeres adolescentes/jóvenes embarazadas o que estén dando el pecho no son elegibles para este estudio.
    E.4Principal exclusion criteria
    - Participants with ongoing anticoagulation treatment with warfarin or equivalent vitamin K antagonists (example phenprocoumon), or ongoing treatment with agents known to be strong CYP3A4/5 inhibitors, or has taken any disallowed therapies as noted in Section 8.2, Prohibited Medications, before the planned first dose of study drug
    - Participants with inherited or acquired bleeding disorders
    - Participants with clinically significant arrhythmias, complex congenital heart disease, or left ventricular ejection fraction (LVEF) <50 percent (%) or shortening fraction (SF) <=28%
    - Participants with known history of human immunodeficiency virus (HIV) or active Hepatitis B or C virus
    - Participants with any condition that could interfere with the absorption or metabolism of ibrutinib including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel
    - Participants with known allergies, hypersensitivity, or intolerance to ibrutinib or its excipients (refer to Investigator's Brochure)
    -Tratamiento actual con anticoagulantes como warfarina o antagonistas equivalentes de la vitamina K (por ejemplo fenprocoumon), o tratamiento actual con productos que son inhibidores potentes de CYP3A4/5, o cualquier tratamiento no permitido como se indica en la Sección 8.2, Medicación prohibida, antes de la primera dosis prevista del fármaco del estudio -Trastornos de la coagulación hereditarios o adquiridos -Arritmias clínicamente significativas, cardiopatía congénita compleja o fracción de eyección ventricular izquierda (FEVI) < 50 % o fracción de acortamiento (FA) ≤ 28 % -Antecedentes conocidos de (VIH) o virus de la hepatitis B o C activos -Cualquier afección que pueda interferir con la absorción o el metabolismo de ibrutinib como síndrome de malabsorción, enfermedad que afecte significativamente a la función gastrointestinal o resección de estómago o intestino delgado -Alergias conocidas, hipersensibilidad o intolerancia a ibrutinib o a sus excipientes (ref M. del investigador)
    E.5 End points
    E.5.1Primary end point(s)
    1/ Part 1: Area Under The Plasma Concentration-Time Curve (Auc) of Ibrutinib
    2/ Part 1: Apparent (oral) Plasma Clearance (CL/F) of Ibrutinib
    3/ Part 1: Apparent (oral) Volume of Distribution (Vd/F) of Ibrutinib
    4/ Part 1: Maximum Observed Plasma Concentration (Cmax)
    5/ Part 1: Relationship Between Pharmacokinetic Parameters and Age or Measure of Body Size
    6/ Part 2: Event-free Survival [EFS]) of Ibrutinib
    1/Parte 1: Área bajo la concentración plasmática-tiempo de curva (AUC) de Ibrutinib
    2/Parte 1: Aparente (oral) aclaramiento plasmático de Ibrutinib (CL/F)
    3/Parte 1: Volumen aparente (oral) de distribución de Ibrutinib (Vd/F)
    4/Part 1: Concentración plasmática máxima observada (Cmax)
    5/Parte 1: Relación entre los parámetros farmacocinéticos la edad o la medida del tamaño corporal
    6 / Parte 2: Evento de supervivencia libre de Ibrutinib [EFS])
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-4 /Predose and at 1, 2, 4, and 6 hours postdose on Day 1 and on Day 7 or 8 of cycle 1; predose, 1, 2, 4, and 6 hours postdose on Day 1 of Cycle 2 or Cycle 3.
    5/ up to three 28-day cycles
    6/ Randomization to death, disease progression, or lack of CR or PR after 3 cycles of treatment (approximately 4.2 years)
    1-4 /Antes de la dosis, a las 1, 2, 4, y 6 horas después de la dosis en el día 1 y el día 7 o 8 del ciclo 1; antes de la dosis, 1, 2, 4, y 6 horas después de la dosis en el día 1 del Ciclo 2 o del Ciclo 3.
    5 / Hasta tres ciclos de 28 días
    6 / La asignación, al azar hasta la muerte, progresión de la enfermedad, o la falta de RC o RP después de 3 ciclos de tratamiento (aproximadamente 4.2 años)
    E.5.2Secondary end point(s)
    1/ Part 1: Number of Participants with Adverse Events
    2/ Part 1: Percentage of Participants Who Achieve Complete Response (CR) and Partial Response (PR)
    3/ Part 1: Disease-specific Biomarkers Assessment
    4/ Part 1: Bruton’s tyrosine kinase (BTK) Percent Occupancy
    5/ Part 1: Visual analog Scale Score for Palatability
    6/ Part 2: Number of Participants with Adverse Events
    7/ Part 2: Percentage of Participants Who Achieve Complete Response (CR) and Partial Response (PR)
    8/ Part 2: Tumor Volume Reduction
    9/ Part 2: Percentage of Participants who Proceed to Stem Cell Transplantation
    10/ Part 2: Time to Response
    11/ Part 2: Duration of Response
    12/ Part 2: Percentage of Participants with Long-term Survival
    13/ Part 2: Overall Survival
    14/ Part 2: Disease-specific Biomarkers Assessment
    15/ Part 2: Bruton’s tyrosine kinase (BTK) Percent Occupancy
    16/ Part 2: Visual analog Scale Score for Palatability
    17/ Part 2: Area under the plasma concentration-time curve (AUC)
    1/Parte 1: Número de participantes con eventos adversos
    2/Parte 1: Porcentaje de participantes que lograr una respuesta completa (RC) y respuesta parcial (RP)
    3/Parte 1: Evaluación de biomarcadores de la enfermedad-específica
    4/Part 1: Tirosina quinasa de Bruton (BTK) Porcentaje de ocupación
    5/Parte 1: Escala visual analógica de puntuación para palatabilidad
    6/Parte 2: Número de participantes con eventos adversos
    7/Parte 2: Porcentaje de participantes que logran una respuesta completa (RC) y respuesta parcial (RP)
    8/Parte 2: Reducción del volumen tumoral
    9/Parte 2: Porcentaje de participantes que progresan al trasplante de células madre
    10/Parte 2: Tiempo hasta la respuesta
    11/Parte 2: Duración de la respuesta
    12/Parte 2: Porcentaje de participantes con la supervivencia a largo plazo
    13/Parte 2: La supervivencia global
    14/Parte 2: Evaluación de biomarcadores de la enfermedad-específica
    15/ Parte 2: Tirosina quinasa de Bruton (BTK) Porcentaje de ocupación
    16/Parte 2: Escala visual analógica de puntuación para palatabilidad
    17/Parte 2: El área bajo la curva de concentración plasmática-tiempo (AUC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ Throughout the study duration (approx up to 4.2yrs)
    2/ Treatment Phase:D14 (Cy1),end of Cy2,EOT visit;Post treatment phase:every 12wks for first 12m,every 6m until PD/clinical cutoff for primary endpoint/or upto 2yrs after last subject enrolled,whichever occurs first
    3/ Cy1 D1, Cy2 D1, Cy3 D1&EOT visit
    4/ 4 hrs postdose on D1 and D7 or 8 of Cy1, predose on Cy2 D1 or Cy3 D1, and the EOT visit
    5/ Cy1 D1&y3 D1
    6/ Throughout the study duration (approx up to 4.2yrs)
    7/ idem timepoint nbr 2
    8/ D14
    9/ Cy2 (D28)
    10-11/ Up to 4.2yrs
    12/ 2, 3yrs
    13/ Randomization to the date of death (maximum up to 4.2yrs)
    14/ Cy1 D1, Cy2 D1, Cy3 D1 and EOT visit
    15-16/ Cy1 D1 & Cy3 D1
    17/ Predose; 1, 2, and 4 hrs postdose, either on D7 or 8 of Cy1 or on D1 of Cy2 (or Cy3)
    1/A lo largo de la dur. del estud. (aprox. hasta 4.2a.)
    2/Fase de Trat.: D14 (Cy1), final de Cy2, visita EOT; fase de trat. post: cada 12s. dur. los 12 primeros m, cada 6m. hasta corte clinico de la 1ª variable, hasta 2 a. desp. últ. pac. inscrito, lo que ocurra primero
    3/Cy1 D1, D1 Cy2, Cy3 D1 y EOT visita
    4/4 h. desp. de la dosis en D1 y D7 u 8 de Cy1, antes de la dosis en Cy2 D1 o D1 Cy3, y la visita EOT
    5/Cy1 D1 y D1 y3
    6/A lo largo de la dur. del estud. (aprox hasta 4.2a)
    7/Idem punto de tiempo de 2 NBR
    8/D14
    9/Cy2 (D28)
    10-11/Hasta 4.2a.
    12/2,3 a.
    13/La aleatorización hasta la fecha de la muerte (máx. hasta 4.2a.)
    14/Cy1 D1, D1 Cy2, Cy3 D1 y EOT vis
    15-16/Cy1 D1 y D1 Cy3
    17/antes de la dosis; 1, 2, y 4 h. desp. de la dosis, ya sea en D7 o 8 de Cy1 o en D1 de Cy2 (o Cy3)
    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 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
    Biomarker analysis
    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 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
    Background Chemoimmunotherapy
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Argentina
    Belgium
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Switzerland
    Taiwan
    Turkey
    Ukraine
    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 end of study is defined as when approximately 60 EFS events have occurred in Part 2 (death, disease progression, or lack of CR or PR after 3 cycles of treatment based on blinded independent event review), or the sponsor terminates the study, whichever comes first.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    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: 82
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 45
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    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 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 46
    F.4.2.2In the whole clinical trial 84
    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 of care treatment will be the expected treatment for this condition.
    El tratamiento estándar será el tratamient esperado para esta condición.
    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 Decision2016-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-05
    P. End of Trial
    P.End of Trial StatusOngoing
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