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    Summary
    EudraCT Number:2010-019224-31
    Sponsor's Protocol Code Number:IGR2009/1593
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-19
    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 ConcernedItaly - Italian Medicines Agency
    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
    Trial internazionale per bambini e adolescenti con LNH a cellule B o LLA-B: valutazione dell`efficacia e della sicurezza del Rituximab nei pazienti ad alto rischio
    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
    Trial internazionale per bambini e adolescenti con LNH a cellule B o LLA-B: valutazione dell’efficacia e della sicurezza del Rituximab nei pazienti ad alto rischio
    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 PlanP/009/2001
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorA.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
    B.1.3.4CountryItaly
    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 supportInstitut Gustave Roussy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.I.E.O.P.
    B.5.2Functional name of contact pointsegreteria
    B.5.3 Address:
    B.5.3.1Street AddressVIA MASSARENTI 11
    B.5.3.2Town/ citybologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number051 6364667
    B.5.5Fax number051 345759
    B.5.6E-mailtiziana.landi2@unibo.it
    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*EV 2F 10ML 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 è un anticorpo monoclonale chimerico murino/umano progettato geneticamente
    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*EV 1FL 50ML 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 è un anticorpo monoclonale chimerico murino/umano progettato geneticamente
    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 children or adolescents with PMLBL
    bambini o adolescenti affetti da linfoma primitivo del mediastino (PMLBL)
    E.1.1.1Medical condition in easily understood language
    Untreated children or adolescents with PMLBL
    bambini o adolescenti affetti da linfoma primitivo del mediastino (PMLBL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10036710
    E.1.2Term Primary mediastinal large B-cell lymphoma
    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
    To determine the efficacy of DA-EPOCH-R in children and adolescent PMLB in terms of EFS.
    Determinare l’efficacia del regime terapeutico DA-EPOCH-R nei bambini e adolescenti affetti da PMLBL in termini di EFS.
    E.2.2Secondary objectives of the trial
    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.
    - studiare la percentuale di remissione completa (RC) e la sopravvivenza globale (OS);- valutare la sicurezza in tutti i bracci terapeutici: includendo le morti tossiche,eventi avversi registrati usando la Versione 4 del NCI-CTC (Common Toxicity criteria) (tossicità non ematologica di grado 3,infezioni di grado 3-5),tossicità cardiaca (CTC di grado 2-5 e evoluzione della frazione di eiezione ventricolare sinistra e frazione di accorciamento ventricolare sinistra),numero di trasfusioni piastriniche,numero di trasfusioni di globuli rossi,reazioni alle infusioni di Rituximab e ingresso nell’unità di terapia intensiva;- studiare la percentuale di pazienti con anormale riduzione del livello di Ig (IgM,IgA,IgG) e anormale riduzione della conta di linfociti ad 1 e 5 anni di follow-up; valutare la necessità di infusione di Ig ed i livelli degli anticorpi prima e dopo un anno dall
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    parallel study with the following objectives: evaluate the potential prognostic value of Minimal Dissiminated Disease(MDD) and Residual(MRD) in correlation with outcome; obtain data on PET(CT)

    ALTRI SOTTOSTUDI:
    studio parallelo avente i seguenti obiettivi:valutare il potenziale valore prognostico della Malattia Minima Disseminata(MMD) e Residua(MMR) in correlazione al risultato; analizzare dati della PET(CT)

    E.3Principal inclusion criteria
    - 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.
    ISTOLOGIA E STADIAZIONE DELLA MALATTIA - PMLBL verificato isto-citologicamente; - PMLBL senza l’interessamento dell’SNC. CONDIZIONI GENERALI - Età compresa tra i 6 mesi e i 18 anni al momento del consenso. - Maschi e femmine in età fertile devono accettare di utilizzare un efficace metodo contraccettivo durante il trattamento, e dopo la fine del trattamento: per dodici mesi per le donne, prendendo in considerazione le caratteristiche del rituximab e per cinque mesi per gli uomini, prendendo in considerazione le caratteristiche del methotrexate. WORK-UP INIZIALE - Work-up iniziale completo entro 8 giorni prima della terapia. ALTRI CRITERI DI INCLUSIONE - Rispettare il follow-up programmato e la gestione della tossicità. - Consenso informato firmato dai pazienti e/o dai relativi genitori o dai tutori legali.
    E.4Principal exclusion criteria
    HISTOLOGY AND STAGING DISEASE - 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. GENERAL CONDITIONS - 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. PRIOR THERAPY - Past or current anti-cancer treatment except corticosteroids during less than one week. EXCLUSION CRITERIA RELATED TO RITUXIMAB: - 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.
    ISTOLOGIA E STADIAZIONE DI MALATTIA - Linfoma follicolare, Linfoma marginale extranodale del tessuto linfoide associato alla mucosa (MALT) e Linfoma nodale della zona marginale non sono inclusi nello studio terapeutico. - Nello studio di fase II (PMLBL) i pazienti con coinvolgimento del SNC non sono eleggibili. CONDIZIONI GENERALI - Pazienti con immunodeficienza congenita, sindrome da rottura cromosomica, trapianto d’organo precedente, qualsiasi neoplasia precedente, sierologia HIV positivo nota. - Pazienti in stato di gravidanza o nel periodo di allattamento. - Non ci saranno criteri di esclusione basati sulla funzionalità d’organo. PRETRATTAMENTO - Trattamento chemioterapico passato o presente ad esclusione dei corticosteroidi per una durata inferiore ad una settimana. CRITERI DI ESCLUSIONE CORRELATI AL RITUXIMAB - Cellule tumorali negative per CD20 (assenza di risultati a causa di problemi tecnici nel definire la presenza di altre caratteristiche suggestive di BL/DLBCL, incluse caratteristiche genetiche e fenotipiche, non è un criterio di esclusione) - Precedente esposizione al rituximab. - Infezione virale acuta, specialmente l’epatite B. Le infezioni acute (come una sepsi, polmonite, ecc) dovrebbero essere controllate clinicamente nel momento della randomizzazione. Contattare il coordinatore nazionale per maggiori informazioni se necessario. - Stato di portatore di epatite B, storia di HBV o sierologia positiva.
    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.
    Tempo minimo di morte per qualsiasi causa, presenza di cellule vitali nei residui dopo il 6° ciclo DA-EPOCH , ricaduta, malattia progressiva, o tumore secondario rilevati a partire dalla randomizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18months
    18mesi
    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.
    - Sopravvivenza (S): è tempo di morte per qualsiasi causa, misurato dal momento della randomizzazione - tasso di remissione completa al momento di valutazione - Per i pazienti del gruppo B: la risposta in 3 categorie:-CR al momento della valutazione (dopo CYM1)-slow responder = CR CYVE2 ma non dopo CYM1-no CR - tossicità acuta (ad ogni ciclo) e a lungo termine: morti tossiche, gli eventi avversi di NCI-CTC V4 (non tossicità ematologica di grado> 3, infezioni di grado 3 a 5), tossicità cardiaca (CTC 2-5 grado e anormale frazione di eiezione ventricolare sinistra (LV-EF) o anormale riduzione di frazione del ventricolo sinistro (LV-SF)), il numero di trasfusioni di piastrine e globuli rossi, ricovero nell'unità di terapia intensiva, le reazioni di infusione di rituximab. Secondo le raccomandazioni di diversi autori (Steinherz 1992, Kremer-Van Dalen 2006) la cardiotossicità è definito come segue: LV-EF <55% o LV-SF <28% o una riduzione> 20% del valore basale per una di queste due criteri. - Ricostituzione immunitaria valutata Ig (G, A e M) il livello e la conta dei linfociti ad 1 anno e ogni anno durante il follow-up fino al livello normale, livelli di anticorpi post-vaccinali (tetano, polio, difterite, Haemophilus influenzae e pneumococco) e la necessità di infusione di immunoglobulina .
    E.5.2.1Timepoint(s) of evaluation of this end point
    it depends on the endpoints
    dipendente dagli endpoints
    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 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 Yes
    E.6.13.1Other scope of the trial description
    parallel study - substudy
    studio parallelo - sottostudio
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    LVLS
    LVLS
    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: 5
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    children population
    popolazione pediatrica
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 40
    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
    assistenza standard/fornita nel protocollo
    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 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation BSPHO
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation DCOG
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation PPLLSG
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation SFCE
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Hungarian Society of Pediatric Oncologist
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation SEHOP
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation UK NCRI CCL CSG
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation COG
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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