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    Summary
    EudraCT Number:2012-004056-11
    Sponsor's Protocol Code Number:PCI-32765MCL3002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-19
    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 number2012-004056-11
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma
    Uno studio di fase 3 randomizzato, in doppio cieco, controllato con placebo dell’inibitore della proteina tirosin-chinasi di Bruton (BTK), PCI-32765 (ibrutinib), in combinazione con bendamustina e rituximab (BR) in soggetti con linfoma mantellare (MCL) di recente diagnosi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination with Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
    Uno studio dell’inibitore della proteina tirosin-chinasi di Bruton in combinazione con bendamustina e rituximab in soggetti con linfoma mantellare di recente diagnosi
    A.4.1Sponsor's protocol code numberPCI-32765MCL3002
    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 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-CILAG SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29-2333CM
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71 524 21 66
    B.5.5Fax number+31(0)71 524 21 10
    B.5.6E-mailClinicalTrialsEU@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 No
    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
    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 CodeSUB88115
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mantle Cell Lymphoma
    Linfoma mantellare
    E.1.1.1Medical condition in easily understood language
    Blood cancer
    Tumore del sangue
    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 HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older.
    L'obiettivo primario di questo studio è valutare se l’aggiunta di ibrutinib a bendamustina e rituximab risulterà in un prolungamento della sopravvivenza libera da progressione (PFS) in soggetti affetti da linfoma mantellare (MCL) di recente diagnosi, di età uguale o superiore a 65 anni.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
     To evaluate overall survival
     To evaluate the CR rate and overall response rate (CR+PR)
     To evaluate patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
     To evaluate the minimal residual disease (MRD) negative rate
     To evaluate duration of response
     To evaluate time-to-next treatment (TTNT)
     To evaluate the safety of ibrutinib when combined with BR
     To characterize the pharmacokinetics of ibrutinib and explore the potential relationships between ibrutinib metrics of exposure with relevant clinical, pharmacodynamic, or biomarker information
    Gli obiettivi secondari sono:
    Valutare la sopravvivenza generale;
    Valutare il tasso di CR e il tasso di risposta generale (CR) + risposta parziale (PR)];
    Valutare i sintomi del linfoma riferiti dai pazienti e problemi misurati tramite la sottoscala del linfoma (Lym) del questionario FACT-Lym;
    Valutare il tasso negativo della malattia residua minima (MRD);
    Valutare la della durata della risposta; Valutare l’intervallo prima del trattamento successivo (TTNT);
    Valutare la sicurezza di ibrutinib in combinazione con BR.
    Valutare la caratterizzazione della farmacocinetica di ibrutinib e analizzare le potenziali relazioni tra le metriche di esposizione di ibrutinib con i dati rilevanti di tipo clinico, di farmacodinamica o biomarcatori.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of mantle cell lymphoma (MCL) reviewed and approved by central laboratory: diagnosis must include morphology and expression of either cyclin D1 in association with one B-cell marker (eg, CD19, CD20, or PAX5) and CD5 or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
    - Clinical Stage II, III, or IV by Ann Arbor Classification
    - At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
    - No prior therapies for MCL
    - Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
    - Hematology and biochemical laboratory values within protocol-defined limits
    - Agrees to protocol-defined use of effective contraception
    - Negative blood or urine pregnancy test at screening
    1. La diagnosi di MCL controllata ed approvata dal laboratorio centrale: la diagnosi deve includere la morfologia e l’espressione della ciclina D1 in associazione ad un marcatore delle cellule B (ad es. CD19, CD20, o PAX5) e CD5 oppure mostrare la traslocazione t(11;14) valutata con il test citogenetico, l'ibridazione fluorescente in situ (FISH) oppure con la reazione a catena della polimerasi (PCR).
    2. Stadio clinico II, III o IV secondo la classificazione Ann Arbor
    3. Almeno 1 sito misurabile della malattia in base ai Criteri di Risposta Corretti per Linfoma Maligno (Revised Response Criteria for Malignant Lymphoma)
    4. Nessuna precedente terapia per l'MCL.
    5. Punteggio ECOG (Eastern Cooperative Oncology Group) di 0 o 1.
    6. I valori ematologici e biochimici devono essere compresi nei limiti definiti in protocollo
    7. Accordo all’utilizzo di metodi contraccettivi efficaci
    8. Test di gravidanza negativo sul siero o sulle urine
    E.4Principal exclusion criteria
    - Major surgery within 4 weeks of random assignment
    - Known central nervous system lymphoma
    - Diagnosed or treated for malignancy other than MCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of disease
    - Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant
    - History of stroke or intracranial hemorrhage within 6 months prior to random assignment
    - Requires anticoagulation with warfarin or equivalent vitamin K antagonists
    - Requires treatment with strong CYP3A4/5 inhibitors
    - Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
    - Vaccinated with live, attenuated vaccines within 4 weeks of random assignment
    - Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics
    - Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the patient’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
    1. Intervento chirurgico importante entro 4 settimane dalla randomizzazione.
    2. Linfoma noto del sistema nervoso centrale.
    3. Diagnosi di o trattati per tumore maligno diverso da MCL, fatta eccezione per: neoplasia trattata con intento curativo e assenza di malattia attiva nota per ≥ 3 anni prima della randomizzazione; cancro della pelle diverso dal melanoma o lentigo maligna adeguatamente trattati senza evidenza di malattia; carcinoma della cervice in situ adeguatamente trattato senza evidenza di malattia.
    4. Soggetti il cui obiettivo della terapia è la riduzione del tumore prima del trapianto di cellule staminali.
    5. Anamnesi di ictus o emorragia intracranica entro i 6 mesi precedenti la randomizzazione.
    6. Necessità di terapia anticoagulante con warfarin o equivalenti antagonisti della vitamina K
    7. Necessità di trattamento con forti inibitori del CYP3A4/5.
    8. Malattia cardiovascolare clinicamente significativa, come aritmie sintomatiche o non controllate, insufficienza cardiaca congestizia o infarto del miocardio nei 6 mesi precedenti lo screening o altra malattia cardiaca di classe 3 (moderata) o classe 4 (grave) secondo la definizione della New York Heart Association Functional Classification.
    9. Soggetti vaccinati con vaccini attenuati vivi entro 4 settimane dalla randomizzazione.
    10. Storia nota di infezione da virus dell'immunodeficienza umana (HIV) o da virus dell'epatite C (HCV) attiva o da virus dell'epatite B (HBV) attiva o di qualsiasi infezione sistemica non controllata che richieda antibiotici per via endovenosa
    11. Presenza di una malattia potenzialmente mortale, condizioni mediche o disfunzioni degli organi che, secondo lo sperimentatore, potrebbero compromettere la sicurezza del soggetto, interferire con l'assorbimento o il metabolismo delle capsule di ibrutinib o che potrebbero mettere a rischio i risultati dello studio.

    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    Sopravvivenza senza progressione di malattia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to the end-of-study visit until 265 progression-free survival events have been observed (up to 7 years after the last patient is randomized)
    Fino alla visita di fine studio quando 265 eventi di sopravvivenza senza progressione di malattia saranno stati osservati (fino a 7 anni dopo l'ultimo paziente randomzzato)
    E.5.2Secondary end point(s)
    1) Overall survival
    Time frame = up to the end-of-study visit until 60% of all enrolled
    patients have died (up to 7 years after the last patient is randomized)

    2) Overall response rate
    Time frame = up to the end-of-study visit up to 7 years after the last
    patient is randomized

    3) Number of participants with change in Lym subscale scores of the
    Functional Assessment of Cancer Therapy-Lymphoma (FACT Lym)
    Time frame = screening, Day 1 of the first 6 cycles, then every 12 weeks
    in the first 12 months, thereafter every 16 weeks up to 7 years after the
    last patient is randomized

    4) Minimal residual disease negative rate
    Time frame = for participants with complete response, every 12 weeks in
    the first 12 months, thereafter every 16 weeks and at disease
    progression or up to the end-of-study visit (up to 7 years after the last
    patient is randomized)

    5) Duration of response
    Time frame = up to the end-of-study visit up to 7 years after the last
    patient is randomized

    6) Time-to-next treatment
    Time frame = up to the end-of-study visit up to 7 years after the last
    patient is randomized

    7) Number of participants affected by an adverse event
    Time frame = up to 30 days after the last dose of study medication

    8) Oral plasma clearance of ibrutinib as derived from population
    pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose

    9) Oral volume of distribution at steady state of ibrutinib as derived from
    population pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose

    10) Area under the concentration curve of ibrutinib as derived from
    population pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose

    11) Minimum observed plasma concentration of ibrutinib as derived from
    population pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose

    12) Maximum observed plasma concentration of ibrutinib as derived
    from population pharmacokinetics
    Time frame = predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1
    and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose
    1) Sopravvivenza generale
    Tempistica: fino alla visita di fine studio fino al decesso del 60% di tutti i pazienti arruolati (fino a 7 anni dopo l’ultimo paziente randomizzato
    2) Tasso di risposta generale
    Tempistica: fino alla visita di fine studio fino fino a 7 anni dopo l’ultimo paziente randomizzato
    3) Numero si partecipanti con una variazione del punteggio della sottoscala Lym del Functional Assessment of Cancer Therapy-Lymphoma (FACT Lym)
    Tempistica: allo screening, Giorno 1 dei primi 6 Cicli, poi ogni 12 settimane nei primi 12 mesi e successivamente ogni 16 settimane fino a 7 anni dopo l’ultimo paziente randomizzato
    4)Tasso negativo di malattia minima residua
    Tempistica: per i partecipanti con risposta completa ogni 12 settimane nei primi 12 mesi poi ogni 16 settimane e a progressione di malattia oppure fino alla visita di fine studio (fino a 7 anni dopo l’ultimo paziente randomizzato)
    5) Durata della risposta
    Tempistica: fino alla visita di fine studio fino a 7 anni dopo l’ultimo paziente randomizzato)
    6) Tempo al trattamento successivo
    Tempistica: fino alla visita di fine studio fino a 7 anni dopo l’ultimo paziente randomizzato
    7) Numero di partecipanti con evento avverso
    Tempistica: fino a 30 giorni dopo l’ultima dose di farmaco in studio
    8) Clearance plasmatica orale di ibrutinib derivata dalla popolazione farmacocinetica
    Tempisitica = predose al Giorno 2 Cicli 1-3, postdose al Giorno 2 Cicli 1
    e 2 al 1, 2, e 4 ore dopo la somministrazione di ibrutinib nella dose dello studio
    9) Volume orale di distribuzione allo steady state di ibrutinib derivato dalla popolazione farmacocinetica
    Tempistica = predose al Giorno 2 Cicli 1-3, postdose al Giorno 2 Cicli 1
    e 2 a 1, 2, e 4 ore dopo la somministrazione di ibrutinib nella dose dello studio

    10) Area sotto la curva di concentrazione di ibrutinib derivata dalla popolazione farmacocinetica
    Tempistica = predose al Giorno 2 Cicli 1-3, postdose al Giorno 2 Cicli 1
    e 2 a 1, 2, e 4 ore dopo la somministrazione di ibrutinib nella dose dello studio

    11) Concentrazione di ibrutinib plasmatica minima osservata derivata dalla popolazione farmacocinetica
    Tempistica = predose al Giorno 2 Cicli 1-3, postdose al Giorno 2 Cicli 1
    e 2 a 1, 2, e 4 ore dopo la somministrazione di ibrutinib nella dose dello studio

    12) Concentrazione di ibrutinib plasmatica massima osservata derivata dalla popolazione farmacocinetica
    Tempistica = predose al Giorno 2 Cicli 1-3, postdose al Giorno 2 Cicli 1
    e 2 a 1, 2, e 4 ore dopo la somministrazione di ibrutinib nella dose dello studio

    E.5.2.1Timepoint(s) of evaluation of this end point
    See above
    vedi sopra
    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
    Analisi dei biomarcatori
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA123
    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
    Australia
    Belgium
    Brazil
    Canada
    Chile
    China
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Peru
    Poland
    Portugal
    Russian Federation
    Singapore
    Slovakia
    Spain
    Sweden
    Taiwan
    Thailand
    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
    End of study, when 60% of the randomized subjects have died or the sponsor terminates the study, whichever comes first.
    Fine dello studio al raggiungimento del 60% dei decessi dei soggetti randomizzati o quando lo Sponsor interrompe lo studio, ovvero quale dei 2 eventi accade per primo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 520
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 278
    F.4.2.2In the whole clinical trial 520
    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)
    The sponsor will ensure that subjects benefiting from treatment with ibrutinib will be able to continue treatment after the end of the study.
    Lo Sponsor assicura che i soggetti che beneficiano del trattament con ibrutinib potranno continuare il trattamento dopo la fine dello studio
    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 Decision2013-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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