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    Summary
    EudraCT Number:2015-005273-20
    Sponsor's Protocol Code Number:FIL-GALILEO
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-27
    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 number2015-005273-20
    A.3Full title of the trial
    Multicenter phase II single arm open-label study on the feasibility, safety and efficacy of combination of CHOP-21 supplemented with Obinutuzumab and Ibrutinib in untreated young high risk Diffuse Large B-cell Lymphoma (DLBCL) patients.
    Multicenter phase II single arm open-label study on the feasibility, safety and efficacy of combination of CHOP-21 supplemented with Obinutuzumab and Ibrutinib in untreated young high risk Diffuse Large B-cell Lymphoma (DLBCL) patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter phase II single arm open-label study on the feasibility, safety and efficacy of combination of CHOP-21 supplemented with Obinutuzumab and Ibrutinib in untreated young high risk Diffuse Large B-cell Lymphoma (DLBCL) patients.
    Studio multicentrico di fase II a braccio singolo sulla fattibilit¿, sicurezza ed efficacia della combinazione CHOP-21 con Obinutuzumab e Ibrutinib come terapia di prima linea in pazienti giovani ad alto rischio affetti da linfoma a grandi cellule B.
    A.3.2Name or abbreviated title of the trial where available
    FIL-GALILEO
    FIL-GALILEO
    A.4.1Sponsor's protocol code numberFIL-GALILEO
    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 supportRoche
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportJanssen - Cilag
    B.4.2CountryBelgium
    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 pointUffici Studi FIL
    B.5.3 Address:
    B.5.3.1Street AddressSpalto Marengo 43
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.3.4CountryItaly
    B.5.4Telephone number0131 206066
    B.5.5Fax number0131 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 GAZYVARO - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 1000MG/40ML - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 INNObinutuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeGA101
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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 typeGlyco-engineered and humanized monoclonal antibody
    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 IMBRUVICA - 140 MG -CAPSULE RIGIDE -USO ORALE - FLACONE (HDPE) - 1 FLACONE (90 CAPSULE RIGIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V.
    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.3.1Product nameImbruvica
    D.3.2Product code Ibrutinib
    D.3.4Pharmaceutical form Capsule, hard
    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 codeIbrutinib
    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 number90
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diffuse Large B-Cell lymphoma (DLBCL)
    Linfoma a grandi cellule B (DLBCL)
    E.1.1.1Medical condition in easily understood language
    Diffuse Large B-Cell lymphoma
    Linfoma a grandi cellule B
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012855
    E.1.2Term Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)
    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
    To evaluate the efficacy of G-CHOP-21 in combination with Ibrutinib in terms of 2-yrs PFS; To evaluate the safety of G-CHOP-21 in combination with Ibrutinib (extra-hematologic toxicity = grade 3 or treatment interruption for safety reasons or any toxic death during the 6 cycles of treatment).
    Valutare l'efficacia del G-CHOP 32 in combinazione con Ibrutinib in termini di PFS a 2 anni; valutare la sicurezza di G-CHOP-21 in combinazione con Ibrutinib (tossicit¿ extra ematologica = grado 3 o interruzione del trattamento per ragioni di sicurezza o qualsiasi morte tossica durante i 6 cicli di trattamento)
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy in terms of Overall survival (OS);
    To evaluate the Complete Response (CR) rate and Overall Response Rate (ORR) (Lugano 2014);
    To evaluate the duration of response (DoR) after the end of treatment.
    Valutare l'efficacia in termini di sopravvivenza globale (OS); valutare il tasso di risposte complete e il tasso di risposte complessive (ORR) (Lugano 2014)
    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 types of substudies
    Specify title, date and version of each substudy with relative objectives: Protocollo principale, pagg 86-87 paragrafi 22-23

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Protocollo principale, pagg 86-87 paragrafi 22-23
    E.3Principal inclusion criteria
    - Histologically confirmed DLBCL not otherwise specified (NOS)
    - Previously untreated disease
    - Age 18–60
    - Age adjusted IPI=2-3
    - Ann Arbor stage II–IV disease
    - Measurable disease = 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions
    - Normal blood count as defined as: absolute neutrophil count = 1.0 × 109/L independent of growth factor support, platelet count = 100,000/mm3 or ¿50,000/mm3 if bone marrow involvement independent of transfusion support in either situation
    - Normal organ functions defined as: creatinine =2 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) = 40 ml/min/1.73m2, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =3× the ULN; total bilirubin = 1.5 × the ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is = 3.0 × the ULN; International normalized ratio (INR) < 1.5 × the ULN in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) < 1.5 × the ULN in the absence of a lupus anticoagulant”
    - Patients with occult or prior hepatitis B infection (defined as HBsAg negative, anti-HBs positive and /or anti-HBc positive) may be included if HBV DNA is undetectable. These patients must be willing to undergo bi-monthly DNA testing and they should receive prophylaxis with Lamivudine
    - No active HCV infection
    - Known availability of biopsy material
    - No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)
    - Absence of active infections
    - Non peripheral neuropathy or active neurological non neoplastic disease of CNS
    - Non major surgical intervention prior 3 months to enrollment if not due to lymphoma and/or not other disease life-threatening that can compromise chemotherapy treatment
    - Patient with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study
    - Patients with any other malignancy that has been treated with surgery alone with curative intent and the malignancy has been in remission without treatment for at least 5 years prior to enrollment
    - Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 6 months after the last dose of study drug. For males, these restrictions apply for 6 months after the last dose of study drug
    - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [¿-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study
    - Life expectancy > 6 months
    - Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

    - Diagnosi di DLBCL non diversamente specificata (NOS) confermata istologicamente
    - Malattia non precedentemente trattata
    - Età 18–60 anni
    - Age adjusted IPI=2-3
    - Malattia in stadio II–IV secondo Ann Arbor
    - Malattia misurabile di almeno 1.5 cm nel diametro più lungo e misurabile in due dimensioni perpendicolari
    - Emocromo normale, definito come:
    • conta assoluta dei neutrofili (ANC) = 1.0 × 109/L, indipendentemente dal supporto con fattori di crescita
    • piastrine = 100.000/mm3 o 50.000/mm3 in caso di interessamento midollare e indipendentemente da un eventuale supporto trasfusionale in entrambi i casi.
    - Normale funzionalità d’organo, definita come:
    • creatinina = 2 volte il limite superiore del valore normale (upper limit of normal, ULN) o velocità di filtrazione glomerulare stimata (Cockroft-Gault) = 40 mL/min/1.73m2);
    • aspartato aminotransferasi (AST/SGOT) o alanina aminotransferasi (ALT/SGPT) = 3 × ULN;
    • bilirubina totale = 1.5 × ULN, a meno che l’aumento della bilirubina non sia da ascrivere a sindrome di Gilbert o abbia origine extra-epatica; pazienti con sindrome di Gilbert documentata potranno essere arruolati se la bilirubina totale è = 3.0 × ULN;
    • International normalized ratio (INR) < 1.5 × ULN in assenza di terapia anticoagulante; tempo di tromboplastina parziale (PTT) o tempo di tromboplastina parziale attivata (aPTT) < 1.5 × ULN in assenza di Lupus anticoagulante (LAC)
    - Pazienti con infezione occulta o pregressa da virus dell’epatite B (definita come HBsAg negativo, anti-HBs positivo e/o anti-HBc positivo) possono essere inseriti in studio se il DNA virale non è rilevabile. Tali pazienti devono acconsentire all’esecuzione del test per la rilevazione del DNA virale ogni 2 mesi e devono ricevere una profilassi con Lamivudina
    - Assenza di infezione attiva da HCV
    - Disponibilità del materiale bioptico per lo studio
    - Assenza di interessamento del Sistema Nervoso Centrale (coinvolgimento meningeo o cerebrale da parte del linfoma)
    - Assenza di infezioni attive
    - Assenza di neuropatia periferica o di malattia neurologica non neoplastica attiva del Sistema Nervoso Centrale
    - Assenza di interventi chirurgici importanti nei 3 mesi precedenti l’entrata in studio, fatto salvo per quelli dovuti al linfoma, e/o altre patologie potenzialmente letali che possano compromettere la somministrazione della chemioterapia
    - Pazienti con anamnesi di carcinoma basale o squamoso, o melanoma della cute trattato con intento curativo, o pazienti con carcinoma in situ della cervice uterina, diagnosticati e trattati in qualsiasi momento prima dell’entrata in studio
    - Pazienti con anamnesi di qualsiasi altra neoplasia che sia stata trattata con la sola chirurgia con intento curativo e in remissione dal almeno 5 anni senza ulteriore trattamento al momento dell’entrata in studio
    - Donne in età fertile e uomini sessualmente attivi dovranno adottare un metodo di elevata efficacia nel controllo delle nascite sia durante che dopo la studio in accordo con le normative locali relative al controllo delle nascite. Gli uomini dovranno astenersi dal donare il seme durante e dopo lo studio. Per le donne le restrizioni si applicano fino 6 mesi dopo avere ricevuto l’ultima dose del trattamento in studio. Per gli uomini le restrizioni si applicano fino a 6 mesi dopo avere ricevuto l’ultima dose del trattamento in studio
    - Donne in età fertile dovranno essere sottoposte a test di gravidanza allo screening e dovranno risultare negative al test per la beta-gonadotropina corionica umana (ß-hCG) nel siero o nelle urine.
    - Aspettativa di vita superiore ai 6 mesi
    - Consenso informato scritto del paziente (o del legale rappresentante del paziente) che attesti la comprensione dello scopo e delle procedure richieste dallo studio e la volontà di prendere parte allo studio
    E.4Principal exclusion criteria
    - Any other histologies than DLBCL: composite or transformed disease and patients with follicular lymphoma IIIB
    - Primary mediastinal lymphoma (PMBL)
    - Known central nervous system lymphoma
    - History of other cancer
    - Any prior lymphoma therapy
    - Contraindication to any drug in the chemotherapy regimen
    - LVEF < 50%
    - Neuropathy = grade 2
    - Seropositive for or active viral infection with hepatitis B virus (HBV)
    - HBsAg positive
    - HBsAg negative, anti-HBs positive and /or anti-HBc positive with detectable viral DNA
    - Known seropositive active HCV
    - HIV infection
    - Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma): creatinine =2 times the upper limit of normal (ULN) (unless creatinine clearance normal, Appendix D), or calculated creatinine clearance < 40 mL/min (using the Cockcroft–Gault formula); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =3× the ULN; total bilirubin > 1.5 × the ULN: patients with documented Gilbert disease may be enrolled if total bilirubin is = 3.0 × the ULN; International normalized ratio (INR) > 1.5 × the ULN in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) > 1.5 × the ULN in the absence of a lupus anticoagulant”
    - History of stroke or intracranial hemorrhage within the past 6 months.
    - Requires anticoagulation with warfarin or equivalent vitamin K antagonists
    - Requires treatment with strong CYP3A inhibitors
    - History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
    - 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 enrollment
    - Presence of major neurological disorders
    - Any uncontrolled active systemic infection requiring intravenous (IV) antibiotics
    - Major surgical intervention prior 4 weeks to enrollment if not due to lymphoma and/or other disease life-threatening that can compromise chemotherapy treatment
    - Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
    - Any other coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
    - Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
    -If female, the patient is pregnant or breast-feeding
    - Qualsiasi diagnosi istologica diversa da DLBCL, forme composite o linfomi trasformati, pazienti con diagnosi di linfoma follicolare di grado IIIB
    - Linfomi primitivi del mediastino (PMBL)
    - Linfoma noto del Sistema Nervoso Centrale
    - Pazienti non vergini da trattamento
    - Controindicazione a qualsiasi farmaco nel regime chemioterapico
    - LVEF < 50%
    - Neuropatia di grado = 2
    - Sieropositività per o infezione virale attiva da virus dell’epatite B (HBV)
    - HBsAg positività
    - HBsAg negatività, anti-HBs positività e/o anti-HBc positività con DNA virale rilevabile
    -Sieropositività nota a, oppure infezione virale in corso per, il virus dell’epatite C (HCV)
    - Sieropositività nota a, oppure infezione virale in corso per, il virus dell’immunodeficienza umana (human immunodeficiency virus, HIV).
    - Valori anormali per uno qualsiasi dei seguenti parametri di laboratorio (a meno che non dovuti al linfoma):
    • creatinina = 2 volte il limite superiore del valore normale (upper limit of normal, ULN), a meno che la clearance della creatinina sia normale o la clearance della creatinina calcolata < 40 mL/min (usando la formula di Cockroft-Gault);
    • aspartato aminotransferasi (AST/SGOT) o alanina aminotransferasi (ALT/SGPT) = 3 × ULN;
    • bilirubina totale > 1.5 × ULN; pazienti con sindrome di Gilbert documentata potranno essere arruolati se la bilirubina totale è = 3.0 × ULN;
    • International normalized ratio (INR) > 1.5 × ULN in assenza di terapia anticoagulante; tempo di tromboplastina parziale (PTT) o tempo di tromboplastina parziale attivata (aPTT) > 1.5 × ULN in assenza di Lupus anticoagulante (LAC)
    - Anamnesi di ictus o di emorragia intracranica negli ultimi 6 mesi
    - Necessità di trattamento con warfarin o con un equivalente antagonista della vitamina K
    - Necessità di trattamento con forti inibitori del CYP3A
    - Anamnesi di insufficienza epatica o renale clinicamente rilevante; disordini significativi della funzionalità cardiaca, vascolare, polmonare, gastrointestinale, endocrina, neurologica, reumatologica, ematologica, psichiatrica o metabolica
    - Patologie cardiovascolari clinicamente rilevanti quali aritmie non controllate o sintomatiche, insufficienza cardiaca congestizia, o infarto miocardico nei 6 mesi precedenti lo screening, o qualsiasi insufficienza cardiaca moderata o severa (classi 3 e 4 della New York Heart Association Functional Classification)
    - Vaccinazione con vaccini allestiti con virus vivo attenuato nelle 4 settimane precedenti l’entrata in studio
    - Presenza di disturbi neurologici importanti
    - Qualsiasi infezione attiva sistemica non controllata che richieda somministrazione intravenosa (IV) di antibiotici
    - Interventi chirurgici importanti nelle 4 settimane precedenti l’entrata in studio, se non dovuti al linfoma e/o altre patologie potenzialmente letali che possano compromettere la somministrazione della chemioterapia
    - Pregresse neoplasie solide negli ultimi 5 anni, fatta eccezione per carcinoma basale o squamoso o melanoma della cute attualmente in remissione o carcinoma in situ della cervice uterina
    - Qualsiasi altra condizione medica o psicologica che potrebbe precludere la partecipazione allo studio o compromettere la capacità del paziente a fornire il consenso informato
    - Qualsiasi malattia potenzialmente letale, condizione medica o disfunzione d’organo che a giudizio dello sperimentatore potrebbero compromettere la sicurezza del paziente, interferire con l’assorbimento o il metabolismo dell’ibrutinib o mettere a rischio la buona riuscita dello studio
    - per le pazienti femmine, gravidanza o allattamento in corso
    E.5 End points
    E.5.1Primary end point(s)
    1) Progression free survival (PFS) defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause. Progressions will be evaluated according to Response Criteria for NHL with PET (Lugano 2014).
    2) Clinical relevant toxicity defined as the proportion of patients experiencing a grade 3 or greater extra-hematologic toxicity or treatment interruption for safety reasons and any toxic death. Toxicity will be classified according to definitions of Common Terminology Criteria for Adverse Event version 4.03 (CTCAE).
    1) Progression free survival (PFS) calcolata dalla data di arruolamento alla data di recidiva, progressione o morte per qualsiasi causa. Le progressioni saranno valutate secondo i criteri di risposta per i NHL utilizzando la PET (Lugano 2014).
    2) Tossicità clinicamente rilevante definita come proporzione di pazienti con tossicità non ematologica grado 3 o superiore o qualsiasi interruzione per tossicità o morte tossica. La tossicità sarà valutata in accordo con le definizioni del Common Terminology Criteria for Adverse Event version 4.03 (CTCAE).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) PFS will be evaluated at two years, with 2 years of enrolment and 2 years of minimum follow-up
    2) Clinical relevant toxicity will be evaluated during during the 6 cycles of treatment
    1) PFS sarà valutata a 2 anni, con una durata dell’arruolamento di due anni e un follow up minimo di due anni
    2) Tossicità clinicamente rilevante sarà valutata durante i 6 cicli di trattamento
    E.5.2Secondary end point(s)
    Overall Survival (OS) defined as the time between the date of enrolment and the date of death from any cause.; Proportion of Complete remission (CR) according to Response Criteria for NHL with PET (Lugano 2014); Proportion of Overall Response Rate (ORR ¿ Complete and partial response) according to Response Criteria for NHL with PET (Lugano 2014).; Duration of response (DR) measured from the date of complete or partial response at the end of treatment until the date of progression or relapse.; Toxicity determined by the incidence of CTCAE grade 3, 4 and 5 and/or any type of serious adverse events.
    Sopravvivenza complessiva (OS)definita come tempo tra la data di arruolamento e la data di morte per qualsiasi causa; Proporzione di risposte complete (CR) valutate secondo i criteri di risposta per i NHL utilizzando la PET (Lugano 2014); Proporzione di risposte complessive (ORR- risposte complete e parziali) valutate secondo i criteri di risposta per i NHL utilizzando la PET (Lugano 2014); Durata della risposta (DoR) calcolata dalla data di risposta completa o parziale al termine del trattamento fino alla data di progressione o recidiva; Tossicit¿ definita dall¿incidenza di eventi CTCAE di grado 3, 4 o 5 e/o ogni tipo di evento avverso
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years; At the end of 6 cycles ; At the end of 6 cycles ; 2 years; At the end of 6 cycles
    2 anni; Alla fine dei 6 cicli di trattamento; Alla fine dei 6 cicli di trattamento; 2 anni; Alla fine dei 6 cicli di trattamento
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    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 years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 90
    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 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    na
    nd
    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 Decision2016-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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