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    Summary
    EudraCT Number:2010-019224-31
    Sponsor's Protocol Code Number:IGR2009/1593
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2011-10-13
    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 number2010-019224-31
    A.3Full title of the trial
    INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTS
    WITH B-CELL NHL OR B-AL: EVALUATION
    OF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS
    ESTUDIO INTERGRUPO PARA NIÑOS O ADOLESCENTES CON LINFOMA NO-HODGKIN B o LEUCEMIA LINFOBLÁSTICA DE CÉLULAS B: EVALUACIÓN DE LA EFICACIA Y SEGURIDAD DE RITUXIMAB EN PACIENTES DE ALTO RIESGO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTS
    WITH B-CELL NHL OR B-AL: EVALUATION
    OF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS
    ESTUDIO INTERGRUPO PARA NIÑOS O ADOLESCENTES CON LINFOMA NO-HODGKIN B o LEUCEMIA LINFOBLÁSTICA DE CÉLULAS B: EVALUACIÓN DE LA EFICACIA Y SEGURIDAD DE RITUXIMAB EN PACIENTES DE ALTO RIESGO
    A.3.2Name or abbreviated title of the trial where available
    Inter-B-NHL ritux 2010
    Inter-B-NHL ritux 2010
    A.4.1Sponsor's protocol code numberIGR2009/1593
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut Gustave Roussy
    B.1.3.4CountryFrance
    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 supportPharmaceutical Insdustry (Roche)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationI3
    B.5.2Functional name of contact pointFabienne LEKAIM
    B.5.3 Address:
    B.5.3.1Street AddressI3 research Star House 20 Grenfell Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 1EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0033650093505
    B.5.5Fax number0033975613243
    B.5.6E-mailfabienne.lekaim@I3global.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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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 nameMabThera
    D.3.2Product code Ro 45-2294
    D.3.4Pharmaceutical form 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRO 45-2294
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 Yes
    D.3.11.13.1Other medicinal product typeRituximab is a genetically engineered chimeric mouse/human monoclonal antobody
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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 nameMabThera
    D.3.2Product code Ro 45-2294
    D.3.4Pharmaceutical form 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRO 45-2294
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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 Yes
    D.3.11.13.1Other medicinal product typeRituximab is a genetically engineered chimeric mouse/human monoclonal antobody
    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
    untreated advanced stage B-cell NHL or B-AL.
    LNH-B con estadios avanzados o LLA-B, no tratados previamente.
    E.1.1.1Medical condition in easily understood language
    untreated advanced stage B-cell NHL or B-AL.
    LNH-B con estadios avanzados o LLA-B, no tratados previamente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10006595
    E.1.2Term Burkitt's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10067070
    E.1.2Term Follicular B-cell non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10067194
    E.1.2Term Burkitt's leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase III study:
    For the patients with advanced stage B-cell NHL/B-AL (stage III and LDH > Nx2, any stage IV or B-AL) to test whether adding 6 injections of rituximab to standard LMB chemotherapy regimen improves the EFS compared with LMB chemotherapy alone.
    Phase II study:
    To determine the efficacy of DA-EPOCH-R in children and adolescent PMLB in terms of EFS.
    Estudio Fase III:
    Para los pacientes con LNH-B en estadio avanzado o Leucemia de células B maduras (Estadio III con LDH > Nx2, cualquier Estadio IV o LLA-B) comprobar si la adición de 6 inyecciones de Rituximab al régimen estándar de quimioterapia tipo LMB mejora la SLE, en comparación con la administración exclusiva de quimioterapia.
    Estudio Fase II:
    Determinar la eficacia de DA-EPOCH-R en niños y adolescentes con PMLBL en términos de SLE
    E.2.2Secondary objectives of the trial
    In Phase III and phase II studies:
    -To study the complete remission (CR) rate and the overall survival (OS).
    -To evaluate safety on all study arms: including toxic deaths, adverse events recorded using the NCI-CTC V4 (non haematological toxicity grade>3, infections grade 3 to 5), cardiac toxicity (CTC grade 2-5 and evolution of left ventricular ejection fraction and left ventricular shortening fraction), number of days with platelets transfusion, number of days with red cells transfusion, rituximab infusion reactions and intensive care unit admission.
    -To study the rate of patients with Ig (IgM, IgA, IgG) level abnormally low and lymphocyte count abnormally low at 1 year and until 5-year follow-up, and to study the need for immunoglobuline infusions and levels of post (previous and re-)vaccination antibodies at 1 year.
    Estudios Fase III y Fase II:
    - Estudiar la tasa de Remisión completa (RC) y la supervivencia global (SG)
    - Estudiar la seguridad en todas las ramas del estudio, incluyendo las muertes tóxicas, los acontecimientos adversos usando el NCI-CTC V4( toxicidad no-hematológica de grado ? 3, infecciones grado 3 a 5), cardiotoxicidad (CTC grado 2-5 y evolución de la fracción de eyección y de la fracción de acortamiento de ventrículo izquierdo), el número de días bajo transfusión de plaquetas o de hematíes, las reacciones a la infusión de Rituximab y la admisión en unidades de cuidados intensivos.
    -Estudiar la tasa de pacientes con niveles de Ig (IgA, IgG, IgM) anormalmente bajos y con recuentos de linfocitos anormalmente bajos al año y hacer un seguimiento de hasta 5 años y estudiar la necesidad de transfusiones de inmunoglobulinas y los niveles de anticuerpos de vacuna pre- y post-revacunación al año.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    BIOLOGICAL STUDIES, especially MDD and MRD
    Parallel biological studies will be performed, on tumour cells, and/on characteristics of the patients which might modulate response to treatment with or without rituximab. These studies will not concern all the patients of the trial and will be organized by country, some studies being done in several countries altogether.

    COST EFFECTIVENESS ANALYSIS
    The aim of the economic study is to compare the cost-effectiveness ratio between two therapeutic strategies: chemotherapy with anti-CD20 antibody Rituximab (arm 2) versus chemotherapy without Rituximab (arm 1).

    Pharmacokinetics (PK) analysis will be performed in some European centers on a subset of at least 30 patients from selected sites, which must include at least 15 patients in each of two age ranges; 3 to 11 years and 12 to 18 years of age. Centers who will participate to this PK study will receive specific instructions for blood specimen collection, processing and shipping. Specific tubes to collect blood samples will be provided by Roche.
    ESTUDIOS BIOLOGICOS, especialmente MDD y MRD
    Paralelamente se llevarán a cabo estudios biológicos en las células tumorales, y / en las características de los pacientes que podrían modular la respuesta al tratamiento con o sin rituximab. Estos estudios no se realizarán a todos los pacientes del ensayo y será organizados por país, algunos estudios se realizan en varios países conjuntamente
    ANALISIS ECONÓMICO
    El objetivo del estudio económico es comparar la relación coste-efectividad
    entre dos estrategias terapéuticas: la quimioterapia con anticuerpos anti-CD20
    anticuerpo rituximab (grupo 2) y quimioterapia sin Rituximab (grupo 1).
    En algunos centros de países Europeos se llevarán a cabo análisis de farmacocinética (PK) en un subconjunto de al menos 30 pacientes en los centros seleccionados, que debe incluir al menos 15 pacientes en cada uno de los dos rangos de edad, 3-11 años y de 12 a 18 años de edad. Los centros que participarán en este estudio PK recibirán instrucciones específicas para la recogida de muestras de sangre, procesamiento y envío. Roche proporcionará tubos específicos para recoger muestras de sangre
    E.3Principal inclusion criteria
    HISTOLOGY AND STAGING DISEASE
    Phase III study:
    -Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.
    -Stage III with elevated LDH level (?B-high?), [LDH > twice the institutional upper limit of the adult normal values (> Nx2)] or any stage IV or B-AL.
    Phase II study:
    -Histolo-cytologically proven PMLBL.
    -PMLBL without CNS involvement.
    GENERAL CONDITIONS
    -6 months to less than 18 years of age at the time of consent.
    -Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate.
    INITIAL WORK-UP
    -Complete initial work-up within 8 days prior to treatment.
    OTHERS
    -Able to comply with scheduled follow-up and with management of toxicity.
    -Signed informed consent from patients and/or their parents or legal guardians.
    Histología y estadiaje:
    ESTUDIO FASE III:
    - Enfermedad maligna de células B maduras comprobada histológica o citológicamente, ya sea LNH Burkitt o LLA-B (L3) o LNH difuso de células grandes B o LNH agresivo de células B maduras sin otra especificación.
    -Estadio III con LDH elevada (B-high), [LDH > 2 veces el límite institucional más alto para adultos] o cualquier estadio IV o LLA-B.
    ESTUDIO FASE II:
    - Linfoma Mediastínico Primario de células grandes B (PMLBCL) probado histológicamente.
    - Linfoma Mediastínico Primario de células grandes B (PMLBCL) sin afectación del SNC.
    Condiciones generales
    - 6 meses a <18 años de edad en el momento del consentimiento.
    Condiciones generales
    - 6 meses a <18 años de edad en el momento del consentimiento.
    - Los chicos y chicas con potencial reproductivo deben aceptar la utilización de un método contraceptivo eficaz durante el tratamiento. Una vez terminado, las mujeres deberán continuarlo durante 12 meses, dadas las características del Rituximab, y los varones durante 5 meses, dadas las características del Metotrexate.
    Evaluación inicial:
    - Completar la evaluación inicial en los 8 días previos al comienzo del tratamiento
    Otros:
    - Posibilidad de cumplir el seguimiento establecido y el manejo de la toxicidad
    - Firma del consentimiento informado por los pacientes y/o sus padres o tutores.
    E.4Principal exclusion criteria
    -Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study.
    -In phase II study (PMLBL) patients with CNS involvement are not eligible.
    -Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
    -Evidence of pregnancy or lactation period.
    -There will be no exclusion criteria based on organ function.
    -Past or current anti-cancer treatment except corticosteroids during less than one week.
    -Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria)
    -Prior exposure to rituximab.
    -Severe active viral infection, especially hepatitis B. Severe infection (such as sepsis, pneumonia, etc..) should be clinically controlled at the time of randomisation. Contact the national co-investigator for further advice if necessary.
    - Hepatitis B carrier status history of HBV or positive serology
    - Los Linfomas foliculares, MALT y nodular de la zona marginal no están incluidos en este estudio terapéutico.
    - En el estudio Fase II (PMLBL), los pacientes con afectación del SNC no son elegibles.
    - Pacientes con inmunodeficiencia congénita, síndrome de rupturas cromosómicas, trasplante de órgano previo, enfermedad maligna previa de cualquier tipo o serología positiva para VIH.
    - Evidencia de embarazo o periodo de lactancia
    - No hay criterio de exclusión basado en función orgánica
    - Cualquier tratamiento anti-canceroso previo o actual, excepto la administración de corticoides durante un periodo inferior a 1 semana.
    - Células tumorales negativas para CD-20 (La ausencia de resultados debida a problemas técnicos en presencia de otras características sugestivas de LB/DLBCL, incluyendo hallazgos citogenéticos o fenotípicos no es un criterio de exclusión).
    - Exposición previa a Rituximab
    - Infección vírica activa, especialmente Hepatitis B. Infecciones graves (como sepsis, neumonía, etc.?) deben estar clínicamente controladas en el momento de la aleatorización. Si requiere otra opinión, contacte con el coordinador nacional.
    - Estado de portador de Hepatitis B o serología positiva para HBV.
    E.5 End points
    E.5.1Primary end point(s)
    Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from randomization.
    Tiempo mínimo hasta la muerte por cualquier causa, presencia de células viables en los residuos después del 6 ciclos de DA-EPOCH, recaída, progresión de la enfermedad, o segunda neoplasia maligna desde la aleatorización
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 meses
    E.5.2Secondary end point(s)
    - Survival (S): Time to death from any cause, measured from the time of randomization
    - Complete Remission Rate at the assessment time
    - For group B patients: response in 3 categories:
    -CR at assessment time (after CYM1)
    -slow responder = CR at CYVE2 but not after CYM1
    -no CR
    - Acute (at each course) and long term toxicity:
    toxic deaths, adverse events of NCI-CTC V4 (non haematological toxicity grade>3, infections grade 3 to 5), cardiac toxicity (CTC grade 2-5 and abnormal left ventricular ejection fraction (LV-EF) or abnormal left ventricular shortening fraction (LV-SF)), number of platelets transfusion and of red cells transfusion, intensive care unit admission, rituximab infusion reactions.
    According to the recommendations of several authors (Steinherz 1992, Kremer-Van Dalen 2006) the cardiotoxicity is defined as following:
    LV-EF < 55 % or LV-SF <28% or a fall > 20 % of baseline for one of these two criteria.
    - Immune reconstitution assessed by Ig (G, A and M) level and lymphocyte counts at 1 year and every year during follow-up until normal level, post vaccination antibody levels (tetanus, polio, diphtheria, haemophilus influenza and pneumococcus) and need for immunoglobulin infusion.
    Supervivencia (S): Tiempo hasta la muerte por cualquier causa, a partir del momento de la randomización
    - Tasa de remisión completa (RC) en el momento de la evaluación
    - Para los pacientes del grupo B: respuesta en 3 categorías:
    -RCen el momento de la evaluación (después de CYM1)
    -respuesta lenta = RC en CYVE2 pero no después de CYM1
    -no RC
    - Toxicidad aguda (en cada curso) y a largo plazo:
    muertes por toxicidad, acontecimientos adversos usando el NCI-CTC V4( toxicidad no-hematológica de grado ? 3, infecciones grado 3 a 5), cardiotoxicidad (CTC grado 2-5 y evolución de la fracción de eyección y de la fracción de acortamiento de ventrículo izquierdo), número de días bajo transfusión de plaquetas o de hematíes, admisión en unidades de cuidados intensivos, reacciones a la infusión de Rituximab.
    De acuerdo con las recomendaciones de varios autores (Steinherz 1992, Kremer-Van Dalen 2006), la cardiotoxicidad se define de la siguiente manera:
    LV-FE <55% o LV-SF <28% o una caída> 20% desde la visita basal para uno de estos dos criterios.
    -Reconstitución inmune evaluada por Ig (IgA, IgG, IgM) y el nivel de linfocitos en un año y anualmente durante el seguimiento hasta el nivel normal, los niveles de anticuerpos después de la vacunación (tétano, poliomielitis, difteria, haemophilus influenza y el neumococo) y necesidad de transfusiones de inmunoglobulinas
    E.5.2.1Timepoint(s) of evaluation of this end point
    it depends on the endpoints (see E.5.2)
    Depende de la variable secundaria (referirse a la sección E.5.2)
    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 No
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA170
    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
    Australia
    Canada
    New Zealand
    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
    Last visit of the last subject
    Última visita del útimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    E.8.9.2In all countries concerned by the trial months0
    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: 640
    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: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 475
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 159
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 640
    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 care/Provided in the protocol
    Práctica clínica habitual/ Según protocolo
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation AIEOP
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation BSPHO
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation DCOG
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Hungarian Society of Pediatric Oncologist and Pediatric Hamatologist
    G.4.3.4Network Country Hungary
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation PPLLSG
    G.4.3.4Network Country Poland
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation SEHOP
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation SFCE
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation UK NCRI CCL CSG
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation COG
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-18
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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