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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-005739-23
    Sponsor's Protocol Code Number:FIL-RBAC500
    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:2012-03-05
    Trial results View 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 number2011-005739-23
    A.3Full title of the trial
    Phase II study of age‐adjusted R‐BAC (Rituximab, Bendamustine, Cytarabine) as induction therapy in older patients with Mantle Cell Lymphoma (MCL)
    PROTOCOLLO FIL-RBAC500 RITUXIMAB-BENDAMUSTINA-CITARABINA IN PAZIENTI AFFETTI DA LINFOMA NON-HODGKIN MANTELLARE IN PRIMA LINEA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study of age‐adjusted R‐BAC (Rituximab, Bendamustine, Cytarabine) as induction therapy in older patients with Mantle Cell Lymphoma (MCL)
    PROTOCOLLO FIL-RBAC500 RITUXIMAB-BENDAMUSTINA-CITARABINA IN PAZIENTI AFFETTI DA LINFOMA NON-HODGKIN MANTELLARE IN PRIMA LINEA
    A.3.2Name or abbreviated title of the trial where available
    FIL-RBAC500
    FIL-RBAC500
    A.4.1Sponsor's protocol code numberFIL-RBAC500
    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 SponsorFONDAZIONE ITALIANA LINFOMI ONLUS
    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 supportMundipharma
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Italiana Linfomi Onlus
    B.5.2Functional name of contact pointSegreteria
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezia, 16
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code115121
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0131 206066
    B.5.5Fax number+39 0131 263455
    B.5.6E-mailsegreteria@filinf.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 LEVACT*5FL 100MG 2,5MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA GmbH
    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 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 INNBENDAMUSTINE
    D.3.9.1CAS number 16506-27-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB05707MIG
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAGENTE ALCHILANTE
    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 codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeup to
    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 typeAnticorpo Monoclonale
    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 CITARABINA CRINOS*POLV FL500MG
    D.2.1.1.2Name of the Marketing Authorisation holderCRINOS 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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNARA-C
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB20591
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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 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 Yes
    D.3.11.13.1Other medicinal product typeNucleotide sintetico
    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 an established histological diagnosis of MCL on lymph‐node biopsy, bone marrow biopsy, or extranodal tissue.
    Sono eleggibili pazienti con una diagnosi istologica di diagnosi di linfoma mantellare eseguita su linfonodo, BOM, o tessuto estranodale.
    E.1.1.1Medical condition in easily understood language
    Mantle cell Lymphoma
    Linfoma Mantellare
    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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the activity (complete remission rate according to Cheson 2007 criteria) and safety of age‐adjusted Rituximab‐Bendamustine‐Cytarabine (RBAC500) regimen at the end of treatment in older untreated patients with MCL.
    L'obiettivo primario è quello di determinare l'attività (tasso di remissione completa secondo criteri Cheson 2007) e la sicurezza del regime Rituximab-bendamustina-citarabina (RBAC500) alla fine del trattamento nei pazienti anziani non trattati con MC
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine: ‐ The rate of molecular response (characterized by labs of the FIL) ‐The progression‐free survival (PFS) ‐The overall survival (OS) ‐The duration of responses (DOR) ‐The rate of patients that complete the expected treatment schedule (6 courses) ‐ The rate of patients that are subject to dose reductions or delays
    Gli obiettivi secondari sono di determinare: - Il tasso di risposta molecolare - La sopravvivenza libera da progressione (PFS) -La sopravvivenza globale (OS) -La durata della risposta (DOR) -Il tasso di pazienti che completano lo schema di trattamento previsto (6 cicli) - Il tasso di pazienti che sono soggetti a riduzione della dose o ritardi
    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:
    MDR Study: Molecular response is the proportion of patients with molecular rearrangements at baseline that become negative during treatment, measured by qualitative and quantitative PCR.

    ALTRI SOTTOSTUDI:
    Studio sulla Malattia minima residua e sulla risposta molecolare come pervisto dagli end point

    E.3Principal inclusion criteria
    • Previously untreated patients with MCL aged >65 years if they are FIT according to the geriatric CGA assessment. • age 60‐65 years not eliglible to high‐dose chemotherapy plus transplantation, FIT or UNFIT according to the geriatric CGA assessment. • ECOG performance status ≤2. • Positivity for cyclin D1 and SOX11 [the latter being mandatory in cases lacking cyclin D1‐ or t(11;14)‐negative], CD20 and CD5. • Adequate renal function (Creatinine clearance >40 mL/min), with preserved diuresis. • Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) value, total bilirubin <2 mg/dL, unless directly attributable to the patient’s tumor. • Hepatitis B core antibody (HBcAb) positive/HBsAg negative/HBV‐DNA negative patients may be enrolled if correct antiviral prophylaxis is administered at least 2 weeks before initiating protocol treatment. • Written informed consent.
    • pazienti con MCL precedentemente non trattati di età &gt; 65 anni se sono FIT in base alla valutazione geriatrica CGA. • età 60-65 anni non eliglible a chemioterapia ad alte dosi più trapianto, FIT o non idonee in base alla valutazione geriatrica CGA. • performance status ECOG ≤ 2. • positività per la ciclina D1 e SOX11 [quest'ultimo è obbligatorio nei casi mancano ciclina D1-o t (11; 14)-negativi], CD20 e CD5. • Adeguata funzionalità renale (clearance della creatinina &gt; 40 ml / min), con diuresi conservata. • Adeguata funzionalità del fegato: alanina aminotransferasi (ALT) / aspartato aminotransferasi (AST) &lt;2.5 volte il limite superiore del valore normale (ULN), bilirubina totale &lt;2 mg / dl, a meno che tali valori non siano direttamente imputabili al tumore del paziente. • anticorpi anti core dell'epatite B (HBcAb) positivi / HBsAg negativi / pazienti HBV-DNA negativi possono essere arruolati se effettuata una corretta profilassi antivirale almeno 2 settimane prima di iniziare il protocollo di trattamento. • consenso informato scritto.
    E.4Principal exclusion criteria
    • Human immunodeficiency virus (HIV) positive. • Previous treatment for lymphoma • Medical conditions or organ injuries that could interfere with administration of therapy. • Active bacterial, viral, or fungal infection requiring systemic therapy. • Seizure disorders requiring anticonvulsant therapy. • Severe chronic obstructive pulmonary disease with hypoxiemia. • History of severe cardiac disease: New York Heart Association (NYHA) functional class III‐IV, myocardial infarction within 6 months, ventricular tachyarrhythmias, dilatative cardiomyopathy, or unstable angina. • Uncontrolled diabetes mellitus. • Active secondary malignancy. • Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins, to Bendamustine ormannitol. • Major surgery within 4 weeks of study Day 1. • HBsAg+ • HCVAb+ patients with active viral replication (HCV‐RNA+ with AST>2 x normal limit) • Any co‐existing medical or psychological condition that would preclude participation in the study or compromise the patient’s ability to give informed consent, or that may affect the interpretation of the results, or render the patient at high risk from treatment complications. • CNS involvement (a diagnostic lumbar puncture will be performed in patients with the blastoid variant of MCL)
    • HIV positivo • precedente trattamento per il linfoma • Condizioni mediche o lesioni d'organo che potrebbero interferire con la somministrazione della terapia. • Attiva infezione batterica, virale, fungina o che richiede terapia sistemica. • Disturbi del sequestro che richiede terapia anticonvulsiva. • Grave malattia polmonare ostruttiva cronica con hypoxiemia. • Storia di una grave malattia cardiaca: la New York Heart Association (NYHA) di classe funzionale III-IV, infarto miocardico entro 6 mesi, tachiaritmie ventricolari, cardiomiopatia dilatativa, o angina instabile. • diabete mellito non controllato. • tumore maligno secondario. • note reazioni di ipersensibilità o anafilattiche agli anticorpi murini e proteine, per bendamustina o mannitolo. • chirurgia maggiore entro 4 settimane dalla giornata di studio 1. • HBsAg + • HCVAb + pazienti con attiva replicazione virale (HCV-RNA + con AST&gt; 2 volte il limite normale) • Eventuale co-esistente condizione medica o psicologica che potrebbe precludere la partecipazione allo studio o compromettere la capacità del paziente di dare un consenso informato, o che possono influenzare l'interpretazione dei risultati, o rendere il paziente ad alto rischio di complicazioni per il trattamento. • coinvolgimento del SNC (una puntura lombare diagnostica sarà eseguita in pazienti con la variante blastoid di MCL)
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy end point of the study is the proportion of CR defined according to Cheson criteria (2007) at the end of treatment (6 or 4 cycles). Primary safety end point is the occurrence of any of the stop treatment criteria or of any episode of relevant toxicity.
    L'Endpoint primario di efficacia dello studio è la percentuale di Risposte Complete definita secondo criteri di Cheson (2007) alla fine del trattamento (6 o 4 cicli). L'End point primario di sicurezza è la presenza di uno dei criteri definiti per l'interruzione dello studio o di qualsiasi episodio di tossicità rilevante.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 o 4 months
    6 o 4 mesi
    E.5.2Secondary end point(s)
    Secondary end points are MRD defined response, OS, PFS and DOR (Cheson 2007). Molecular response is the proportion of patients with molecular rearrangements at baseline that become negative during treatment, measured by qualitative and quantitative PCR.
    Gli end point secondari sono la risposta definita secondo MRD, OS, PFS e DOR (Cheson 2007). La risposta molecolare è la proporzione di pazienti con riarrangiamenti molecolari al basale, che diventano negativi durante il trattamento, misurata con PCR qualitativa e quantitativa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS is measured from enrollment until death from any cause. PFS is measured from the time of enrollment until disease progression, relapse or death from any cause. DOR is measured from the first assessment that documents response (CR or PR) to the date of disease relapse or progression.
    L'OS è il periodo di tempo che va dall'arruolamento al decesso per ogni causa; PFS è misurato dal momento dell'arruolamento fino alla progressione della malattia, recidiva o morte per qualsiasi causa. DOR è misurata dal momento di valutazione della prima risposta (CR o PR) alla data di recidiva o di progressione della malattia.
    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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned56
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 state57
    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)
    At the end of the trial patients will be followed in accordance with the normal clinical practice
    Al termine della sperimentazione i pazienti verranno seguito secondo quanto previsto dalla normale pratica clinica
    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 Decision2012-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
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