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    Summary
    EudraCT Number:2013-000959-40
    Sponsor's Protocol Code Number:PCI-32765DBL3001
    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:2013-07-19
    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 number2013-000959-40
    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 Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
    Uno studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, sull'inibitore della proteina tirosin-chinasi di Bruton (BTK), PCI-32765 (Ibrutinib), in associazione a Rituximab, ciclofosfamide, doxorubicina, vincristina e prednisone (R-CHOP) in soggetti con nuova diagnosi di linfoma diffuso a grandi cellule B, del sottotipo non derivante dalle cellule del centro germinativo
    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, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
    Uno studio sull'inibitore della proteina tirosin-chinasi di BrutonPCI-32765 (Ibrutinib) in associazione a Rituximab, ciclofosfamide, doxorubicina, vincristina e prednisone in soggetti con nuova diagnosi. di linfoma diffuso a grandi cellule B, del sottotipo non derivante dalle cellule del centro germinativo.
    A.4.1Sponsor's protocol code numberPCI-32765DBL3001
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1139-6222
    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)71524 21 66
    B.5.5Fax number+31(0)71524 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
    Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
    Linfoma diffuso a grandi cellule B del sottotipo non derivante dalle cellule del centro germinativo di nuova diagnosi
    E.1.1.1Medical condition in easily understood language
    Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
    Lnfoma diffuso a grandi cellule B, del sottotipo non derivante dalle cellule del centro germinativo di nuova diagnosi
    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 LLT
    E.1.2Classification code 10012820
    E.1.2Term Diffuse large B-cell lymphoma NOS
    E.1.2System Organ Class 100000004864
    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 evaluate if the addition of ibrutinib to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) prolongs event-free survival (EFS) compared with R-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.
    Valutare se la combinazione di ibrutinib e rituximab, ciclofospamide, doxorubicina, vincristina e prednisone (R-CHOP) prolunga la sopravvivenza libera da eventi (EFS) rispetto alla sola terapia R-CHOP in soggetti affetti da DLBCL non-GCB di nuova diagnosi.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
     Evaluate PFS
     Evaluate overall survival
     Evaluate CR rate
     Evaluate patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
     Evaluate the treatment benefit of ibrutinib in subjects with the ABC subtype based on GEP
     Characterize the pharmacokinetics of ibrutinib and to explore the potential relationships between ibrutinib metrics of exposure with relevant clinical or biomarker information
     Evaluate the safety of ibrutinib when combined with R-CHOP

    The exploratory objectives are to:
     Evaluate patient-reported outcomes (PRO), related to well-being and general health status, utilizing the FACT-Lym and EuroQol questionnaire (EQ-5D-5L)
     Explore the relationship between relevant biomarkers (eg, GEP, gene mutations) with clinical outcomes and mechanism of resistance
    Obiettivi secondari:
    -valutare PFS
    - valutare la sopravvivenza globale
    -valutare il tasso CR
    -valutare sintomi del linfoma e problemi riferiti dai pazienti misurati dalla sottoscala Lym del FACT-Lym
    -valutare i benefici del trattamento con ibrutinib in soggetti affetti dal sottotipo ABC basato su GEP
    -caratterizzare la farmacocinetica di ibrutinib ed esplorare i potenziali legami tra i parametri di esposizione di ibrutinib e le informazioni cliniche o sui biomarcatori pertinenti
    -valutare la sicurezza di Ibrutinib in combinazione con R-CHOP
    Gli obiettivi esplorativi sono:
    -valutazione dei risultati riferiti dai pazienti (PRO) in relazione al benessere e allo stato di salute generale, mediante l'uso di questionari di valutazione funzionale della terapia anticancro del linfoma (FACT-Lym) e EuroQol (EQ-5D-5L)
    -esplorare la relazione fra i biomarcatori pertinenti con i risultati clinici e i meccanismi di resistenza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - No prior treatment for diffuse B-cell lymphoma (DLBCL)
    - Histologically-confirmed nongerminal center B-cell subtype DLBCL
    - Stage II (not candidates for local x-ray therapy), III, or IV disease by the Ann Arbor Classification
    - At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
    - Revised International Prognostic Index score of >=1
    - Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2
    - Hematology and biochemical laboratory values within protocol defined parameters within 14 days prior to random assignment and at baseline
    - Left ventricular ejection fraction within institutional normal limits, as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
    - Agrees to protocol-defined use of effective contraception (for women, these restrictions apply for 12 months after the last dose of rituximab or 1 month after the last dose of study drug, whichever is later; for men, these restrictions apply for 12 months
    after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later)
    - Men must agree to not donate sperm during and after the study for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later
    - Women of childbearing potential must have a negative serum or urine pregnancy test at screening
    -Nessun trattamento precedente per DLBCL
    -DLBCL non-GCB confermato istologicamente
    –Malattia di stadio II (non candidati per terapia locale a raggi X), III o IV secondo la classificazione Ann Arbor
    - Almeno 1 sito misurabile della malattia in base ai Revised Response Criteria for Malignant Lymphoma (Criteri di Risposta Corretti per Linfoma Maligno)
    -Punteggio RIP >=1
    -Punteggio di stato di prestazione ECOG (Eastern Cooperative Oncology Group) DI 0,1 o 2
    -I valori ematologici devono essere compresi nei definiti dal protocollo entro i 14 giorni precedenti la randomizzazione e al basale
    - Frazione di eiezione del ventricolo sinistro nella norma, come determinato tramite ecocardiografia o scansione MUGA (acquisizione a griglia multipla
    -Adozione di misure contraccettive definite nel protocollo (per le donne si applica fino a 12 mesi dopol'ultima dose di rituximab o 1 mese dopo l'ultima dose di farmaco in studio quale dei due eventi accada per ultimo - per gli uomini si applica fino a 12 mesi dopo l'ultima dose di rituximab o 3 mesi dopo l'ultima dose di farmaco in studio quale dei due eventi accada per ultimo)
    -Gli uomini devono acconsentire a non donare lo sperma durante e dopo lo studio per 12 mesi dopo l'ultima dose di rituximab o 3 mesi dopo l'ultima dose del farmaco di studio, a seconda dell'evento che si verifica per ultimo.
    -Le donne in età fertile devono presentare un test di gravidanza sul siero o sulle urine negativo allo screening
    E.4Principal exclusion criteria
    - Major surgery within 4 weeks of random assignment
    - Known central nervous system or primary mediastinal lymphoma
    - Prior history of indolent lymphoma
    - Diagnosed or treated for malignancy other than DLBCL, 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 carcinoma in situ without evidence of disease
    - 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
    - Prior anthracycline use >=150 mg/m2
    - 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
    - Known history of human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics
    - Women who are pregnant or breastfeeding
    - 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
    -Intervento chirurgico importante entro 4 settimane dalla randomizzazione.
    -Soffre di linfoma conosciuto o linfoma mediastinico primario conosciuto
    -Anamnesi di linfoma indolente
    -Diagnosi di o terapia per tumore maligno diverso da DLBCL, fatta eccezione per: tumore maligno trattato 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.
    -Anamnesi di ictus o emorragia intracranica entro i 6 mesi precedenti la randomizzazione
    -Necessità di terapia anticoagulante con warfarin o antagonisti della vitamina K equivalenti
    -Necessità di trattamento con forti inibitori del CYP3A4/5.
    -Uso precedente di antraciclina >=150 mg/m2
    -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.
    -Anamnesi nota di virus dell'immunodeficienza umana (HIV) o virus dell'epatite C attivo o infezione da virus dell'epatite B attivo o qualsiasi infezione sistemica attiva e non controllata che richieda la somministrazione intravenosa di antibiotici
    -Donne in gravidanza o in allattamento
    -Qualsiasi patologia, condizione medica o disfunzione degli organi potenzialmente fatale che, secondo il giudizio dello 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)
    Event-free survival
    Sopravvivenza senza eventi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to disease progression, relapse from complete response, initiation of subsequent systemic antilymphoma therapy after completion of at least 6 cycles of R-CHOP therapy, or death, whichever occurs first, up to Year 7
    Fino alla progressione della malattia, ricaduta dopo completa remissione, inizio di terapia successiva sistemica anti linfoma dopo completamento di almeno 6 cicli di R-CHOP o decesso quale dei due eventi accade prima per un periodo di 7 anni
    E.5.2Secondary end point(s)
    - Progression-free survival
    - Overall survival
    - Complete response rate
    - Time to worsening symptoms in the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
    - Oral plasma clearance of ibrutinib
    - Oral volume of distribution at steady state of ibrutinib
    - Area under the plasma concentration-time curve of ibrutinib
    - Minimum observed plasma concentration of ibrutinib
    - Number of participants affected by an adverse event
    -Sopavvivenza senza progressione
    -Sopravvivenza generale
    -Tasso di risposta
    -Tempistica di peggioramento dei sintomi nella scala FACT-Lym
    - Clearance plasmatica orale di Ibrutinib
    - Volume orale di distribuzione allo “steady state” di ibrutinib
    - Area sotto la curva di concentrazione plasmatica-tempo,
    -Concentrazione plasmatica minima osservata
    -Numero di partecipanti con eventi avversi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Up to disease progression, relapse from complete response, or death, whichever occurs first, up to Year 7
    - Up to the date of the participants death, up to Year 7
    - Up to completion of chemotherapy treatment, up to Year 7
    - Up to the start date of the worsening of patient symptoms, up to Year 7
    - Predose Day 1 of Cycles 1, 2, and 3, and postdose 1 h, 2 h, and 4 h of Cycles 1 and 2
    - Predose Day 1 of Cycles 1, 2, and 3, and postdose 1 h, 2 h, and 4 h of Cycles 1 and 2
    - Predose Day 1 of Cycles 1, 2, and 3, and postdose 1 h, 2 h, and 4 h of Cycles 1 and 2
    - Predose Day 1 of Cycles 1, 2, and 3, and postdose 1 h, 2 h, and 4 h of Cycles 1 and 2
    - Up to 30 days after the last dose of study medication
    -Fino alla progressione della malattia, ricaduta dopo completa remissione, o decesso quale dei due accada prima per un periodo di 7 anni
    - Fino alla data del decesso dei partecipanti per un periodo di 7 anni
    -Fino al completamento del trattamento chemioterapico per 7 anni
    -Fino alla data del peggioramento dei sintomi del paziente per 7 anni
    - Predose giorno 1 del Ciclo 1, 2, e 3, e postdose a 1 ora, 2 ore e 4 ore dei cicli 1 e 2
    - Predose giorno 1 dei Cicli 1, 2 e 3 e postdose a 1 ora, 2 ore e 4 ore dei cicli 1 e 2
    - Predose Giorno 1 dei cicli 1, 2 e 3 e postdose a 1 ora, 2 ore e 4 ore dei cicli 1 e 2
    - Predose Giorno 1 dei cicli 1, 2 e 3 e postdose a 1 ora, 2 ore e 4 ore dei cicli 1 e 2
    - Fino a 30 giorni dopo l'ultima dose di farmaco in studio
    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 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
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    China
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Norway
    Poland
    Russian Federation
    Spain
    Sweden
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as when 50% of the randomized subjects have died or the sponsor terminates the study, whichever comes first.
    Lo studio termina con il decesso del 50% dei soggetti randomizzati o quando lo Sponsor decide di terminare lo studio a seconda dell'evento che 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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial 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 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) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 263
    F.4.2.2In the whole clinical trial 800
    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)
    After the study ends, the Sponsor will not continue to provide ibrutinib. Treatment care after a subject had ended his/her participation in the trial will not be different from the expected normal treatment.
    Dopo la fine dello studio, lo Sponsor non fornirà il farmaco Ibrutinib. Il trattamento dei pazienti dopo il termine dello studio non sarà diverso 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 Decision2013-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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