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    Summary
    EudraCT Number:2012-005338-13
    Sponsor's Protocol Code Number:ONC-2011-004
    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:2013-06-24
    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 number2012-005338-13
    A.3Full title of the trial
    OFATUMUMAB-BENDAMUSTINE FOR RELAPSED/REFRACTORY INDOLENT
    LYMPHOMA: A MULTICENTER PHASE 2 TRIAL
    OFATUMUMAB–BENDAMUSTINA PER I LINFOMI INDOLENTI RECIDIVANTI/REFRATTARI: UNO STUDIO MULTICENTRICO DI FASE II

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Ofatumumab and Bendamustine in patients with lymphoma resistant to previous therapies
    Trattamento con Ofatumumab e Bendamustina in pazienti con linfoma resistente alle precedenti terapie
    A.4.1Sponsor's protocol code numberONC-2011-004
    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 SponsorIstituto Clinico Humanitas - Humanitas Cancer Center
    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 supportRegione Lombardia
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportGlaxoSmithKline
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Clinico Humanitas - Humanitas Cancer Center
    B.5.2Functional name of contact pointU.O. Oncologia ed Ematologia
    B.5.3 Address:
    B.5.3.1Street AddressVia Manzoni, 56
    B.5.3.2Town/ cityRozzano (MI)
    B.5.3.3Post code20089
    B.5.3.4CountryItaly
    B.5.4Telephone number00390282244536
    B.5.5Fax number00390282244591
    B.5.6E-mailmonica.balzarotti@cancercenter.humanitas.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 Arzerra
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group LTD
    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 INNOFATUMUMAB
    D.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 typeHuman 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.2.1.2Country 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 nameBendamustine
    D.3.4Pharmaceutical form Powder for 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 INNBENDAMUSTINE HYDROCHLORIDE
    D.3.9.1CAS number 3543-75-7
    D.3.9.4EV Substance CodeSUB00696MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Hodgkin's Follicular and Non-Follicular indolent lymphomas, relapsed/refractory
    Linfomi non Hodgkin indolenti follicolari e non follicolari, recidivati/refrattari
    E.1.1.1Medical condition in easily understood language
    Indolent Lymphoma
    Linfomi indolenti
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10051812
    E.1.2Term Small cell lymphocytic lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10003908
    E.1.2Term B-cell small lymphocytic lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10029460
    E.1.2Term Nodal marginal zone B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10025342
    E.1.2Term Lymphoplasmacytoid lymphoma/immunocytoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10065856
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10047801
    E.1.2Term Waldenstrom's macroglobulinaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Ofatumumab in combination with Bendamustine
    in previously treated (>=1 chemotherapy lines, at least one rituximab-containing) indolent
    follicular and non follicular non Hodgkin’s lymphomas.
    Valutare l'attività della combinazione Ofatumumab - Bendamustina in pazienti precedentemente trattati con una o più linee di chemioterapia (almeno una contenente rituximab) affetti da linfoma non Hodgkin indolente follicolare e non follicolare.
    E.2.2Secondary objectives of the trial
    - To further characterize the efficacy profile of Ofatumumab-Bendamustine in combination (duration of response, time to next treatment, progression free survival and overall survival, minimal residual disease in follicular lymphoma subtypes).
    - To evaluate safety
    Valutazione del profilo di sicurezza e di efficacia (PFS - OS, tempo al trattamento successivo, durata di risposta, valutazione della MRD solo nei pazienti con linfoma follicolare e correlazione con i parametri clinici) della combinazione Ofatumumab-Bendamustina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent obtained according to local guidelines
    2. Histologically documented diagnosis of grade I-II-IIIa follicular lymphoma or defined according to WHO guidelines 2008. Re-biopsy suggested if transformation to aggressive subtype is suspected OR histologically documented indolent non follicular lymphoma: small lymphocytic lymphoma, lymphoplasmacytoid/lymphoplasmacytic lymphoma, Waldenstrom macroglobulinemia, nodal marginal zone lymphoma
    3. Relapsed or refractory disease after >=1 chemotherapy
    lines, at least one rituximab-containing. Both patients with rituximab–sensitive and rituximab-refractory disease in any previous line are admitted.
    Refractoriness to rituximab is defined as no objective response or documented progression within 6 months of a) receiving the first dose of a full-course single agent rituximab or b) completion of rituximab maintenance therapy or progression before the next rituximab dose or c) completion of a full course
    rituximab in combination with chemotherapy . Previous high dose therapy and autologous stem cell transplantation (ASCT) is also admitted. Previous allogeneic transplantation is excluded.
    4. Age >= 18 years
    5. ECOG performance status 0-2
    6. Locally available histological material
    7. Clinical indication for treatment as determined by the investigator
    8. No prior treatment with bendamustine and/or ofatumumab
    9. Measurable disease by CT scan
    10. Life expectancy of at least 3 months
    11. Laboratory values:
    · Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    unless due to marrow involvement by lymphoma -
    In this case patient can be included upon
    physicians’s decision
    · Platelet count : ≥ 100 x 109/L unless due to marrow
    involvement by lymphoma. In this case patient can
    be included upon physicians’s decision
    · Serum creatinine within normal range
    · Serum total bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome), unless due to lymphoma involvement of the liver. In case of liver
    involvement, patient can be included upon
    physicians’s decision.
    · AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement of the liver
    · alkaline phosphatase ≤ 2.5 times ULN (unless due to disease involvement of the liver or bone). In case of liver or bone involvement, patient can be
    included upon physicians’s decision
    12. Adequate cardiac function : LVEF > 50% through
    echocardiography or MUGA scan
    13. Resolution of all acute toxic effects (excluding alopecia) of any prior therapy to NCI CTCAE (Version 4.03) Grade ≤ 1
    14. Not pregnant or nursing
    15. Negative pregnancy test
    16. Fertile patients must use effective contraception during the study and 3 months after the end of treatment.
    17. Negative HIV test
    18. No other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma
    of the skin, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for
    ≥ 5 years unless approved by the Sponsor Principal Investigator
    1) Firma del consenso informato scritto in accordo con le linee guida locali
    2) Diagnosi documentata istologicamente di linfoma follicolare di grado
    I-II-IIIa o definito in base alle linee guida WHO del 2008.
    Se si sospetta la trasformazione in un sottotipo aggressivo è consigliata la re-biopsia oppure la diagnosi documentata istologicamente di linfoma indolente non follicolare: piccolo linfoma linfocitico, linfoma, linfoplasmacitoide/linfoplasmacitico, macroglobulinemia di Waldenstrom, linfoma della zona marginale nodale.
    3) Malattia refrattaria o progredita dopo una o più linee di chemioterapia, almeno una delle quali contenente rituximab. Sono ammessi sia pazienti con malattia sensibile al rituximab sia pazienti con malattia refrattaria al rituximab in una delle linee di trattamento precedente. La refrattarietà al rituximab è definita come l'assenza di risposta oppure una documentata progressione entro 6 mesi da a) la prima dose di un ciclo completo di rituximab come agente singolo, b) il completamento della terapia di mantenimento con rituximab oppure la progressione prima della dose successiva di rituximab, oppure c) il completamento di un ciclo completo di rituximab in combinazione con chemioterapia. Sono ammessi precedenti terapie ad alte dosi e trapianto autologo di cellule staminali (ASCT). Non è ammesso il precedente trapianto allogenico.
    4) Età ≥ 18 anni
    5) ECOG performance status 0-2
    6) Materiale istologico disponibile localmente
    7) Indicazione clinica per il trattamento decisa dallo sperimentatore
    8) Nessun trattamento precedente con Bendamustina e/o Ofatumumab
    9) Malattia misurabile tramite CT scan
    10) Aspettativa di vita di almeno 3 mesi
    11) Valori di laboratorio:
    • Conta assoluta dei neutrofili (ANC) ≥ 1,5 x 109/L, eccetto a causa del coinvolgimento del midollo da parte del linfoma. In questo caso il paziente può essere incluso per decisione del medico.
    • Conta piastrinica ≥ 100 x 109/L, eccetto a causa del coinvolgimento del midollo da parte del linfoma
    • Creatinina sierica entro range di normalità
    • Bilirubina sierica ≤ 1.5 x ULN (o ≤ 3.0 x ULN se il paziente ha la Sindrome di Gilbert), a meno che sia dovuto a coinvolgimento del fegato da parte del linfoma. In questo caso di coinvolgimento del fegato il paziente può essere incluso per decisione del medico.
    • AST/SGOT e/o ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), o ≤ 5.0 x ULN se l'innalzamento delle transaminasi è dovuto al coinvolgimento della malattia
    • Fosfatasi alcalina ≤2.5 ULN ( a meno che non riguardi il coinvolgimento del fegato e dell’osso). Nel caso di coinvolgimento del fegato e dell’osso, il paziente può essere incluso per decisione del medico.
    12) Adeguata funzione cardiaca: LVEF > 50% attraverso ecocardiografia o MUGA scan
    13) Risoluzione di tutti gli effetti tossici acuti (esclusa l’alopecia) derivanti da precedenti terapie di grado ≤1 NCI CTCAE (versione 4.03)
    14) Non in gravidanza o durante l’allattamento
    15) Test di gravidanza negativo
    16) Pazienti in età fertile devono utilizzare un contraccettivo efficace durante lo studio e fino a 3 mesi dopo la fine del trattamento
    17) Test per HIV negativo
    18) Nessun altro tumore maligno precedente ad eccezione di carcinoma a cellule basali adeguatamente trattato, carcinoma a cellule squamose della pelle, carcinoma in situ della cervice, o altro cancro da cui il paziente è libero da almeno 5 anni, salvo approvazione del protocollo da parte dello sperimentatore principale del centro promotore.
    E.4Principal exclusion criteria
    1. Diagnosis of mucosa associated marginal zone
    lymphoma, splenic marginal lymphoma or chronic
    lymphocytic leukaemia
    2. Evidence of histological transformation to an
    aggressive histological subtype
    3. Previous allogeneic stem cell transplantation
    4. Subjects who have current active hepatic or biliary
    disease (with exception of patients with Gilbert's
    syndrome, asymptomatic gallstones, liver
    involvement by lymphoma or stable chronic liver
    disease per investigator assessment)
    5. Treatment with any known non-marketed drug
    substance or experimental therapy within 5 terminal
    half lives or 4 weeks prior to enrollment, whichever is
    longer, or currently participating in any other
    interventional clinical study.
    6. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 1 month prior to start the
    therapy
    7. Chronic or current infectious disease requiring
    systemic antibiotics, antifungal, or antiviral treatment
    such as, but not limited to, chronic renal infection,
    chronic chest infection with bronchiectasis,
    tuberculosis and active Hepatitis C (see below).
    8. History of significant cerebrovascular disease in the
    past 6 months or ongoing event with active symptoms
    or sequelae
    9. Clinically significant cardiac disease including
    unstable angina, acute myocardial infarction within
    six months prior to randomization, congestive heart
    failure (NYHA III-IV), and arrhythmia unless
    controlled by therapy, with the exception of extra
    systoles or minor conduction abnormalities.
    10. Significant concurrent, uncontrolled medical
    condition including, but not limited to, renal, hepatic,
    gastrointestinal, endocrine, pulmonary, neurological,
    cerebral or psychiatric disease which in the opinion of
    the investigator may represent a risk for the patient.
    11. Any concurrent medical condition requiring long term
    use (> 1 month) of systemic corticosteroids
    12. Any concurrent medical or psychiatric condition
    which might impair administration of therapy or
    preclude the ability to give informed consent
    13. Known hypersensitivity to study drugs, mannitol, or
    any excipients
    14. Positive serology for Hepatitis B (HB) defined as a
    positive test for HBsAg. In addition, if negative for
    HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded. HBV DNA –negative cases can be included provided that HBV monitoring is performed during treatment and follow up period.
    15. Positive serology for hepatitis C (HC) defined as a positive test for HCVAb, in which case reflexively perform a HCVRNA test to confirm the result. Cases with no signs of active chronic hepatitis (= HCV RNA NEG) are admitted.
    16. Women of childbearing potential, including women whose last menstrual period was less than one year
    prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception
    is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
    17. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
    1) Diagnosi di linfoma associato alla regione marginale della mucosa, linfoma marginale splenico o leucemia linfocitica cronica.
    2) Evidenza di trasformazione istologica in un sottotipo aggressivo
    3) Precedente trapianto allogenico di cellule staminali
    4) Soggetti con una malattia epatica o biliare attiva in corso ( con l’eccezione di pazienti con sindrome di Gilbert, calcoli biliari asintomatici, coinvolgimento del fegato da parte del linfoma o malattia cronica stabile del fegato accertate dallo sperimentatore)
    5) Trattamento con qualsiasi farmaco noto non commercializzato o terapia sperimentale entro 5 emivite terminali o 4 settimane precedenti all'arruolamento, qualunque sia il periodo più lungo, o attuale partecipazione in qualsiasi altro studio clinico interventistico
    6) Trattamento precedente con anticorpo monoclonale anti-CD20 o Alemtuzumab entro 1 mese dall'inizio della terapia
    7) Malattia infettiva cronica o in corso che richieda antibiotici sistemici, antifungini o trattamento antivirale, come ad esempio: infezioni renali croniche, infezioni croniche toraciche con bronchiectasie, tubercolosi e epatite C attiva (vedi sotto).
    8) Storia di malattia cerebrovascolare significativa negli ultimi 6 mesi o in corso con sintomatologia attiva o con seguito.
    9) Malattia cardiaca clinicamente significativa inclusa l’angina instabile, infarto miocardio acuto nei sei mesi prima della randomizzazione, insufficienza cardiaca congestiza (NYHA III-IV), e aritmia senza una terapia di controllo, con l’eccezione di extrasistole o disturbi minori della conduzione.
    10) Condizione medica significativa contemporanea incontrollata compresa, ma non limitata a, malattia renale, epatica, gastrointestinale, endocrina, polmonare, neurologica, cerebrale o psichiatrica che, a parere dell'investigatore, potrebbe rappresentare un rischio per il paziente
    11) Qualsiasi condizione medica concomitante che richieda assunzione a lungo termine (> 1 mese) di corticosteroidi sistemici
    12) Qualsiasi condizione medica o psichiatrica concomitante che possa pregiudicare la somministrazione della terapia o precludere la capacità di
    dare un consenso informato
    13) Ipersensibilità nota ai farmaci in studio, a mannitolo o qualsiasi eccipiente
    14) Sierologia positiva per epatite B (HB) definita con un test positivo per HBsAg. Inoltre i soggetti negativi per HBsAg ma positivi per HBcAb (indipendentemente dallo stato di HBsAb), devono sottoporsi ad un test del DNA per HBV e se questo risultasse positivo i sogetti devono essere esclusi dallo studio, se negativo il paziente può essere arruolato purchè venga effettuato regolare monitoraggio.
    15) Sierologia positiva per epatite C (HC) definiti con il test HCVAb; in questo caso effettuare il test HCVRNA per confermare i risultati. Sono ammessi i casi senza alcun segno di epatite cronica attiva (= HCV RNA NEG)
    16) Donne in potenziale età fertile, incluse donne il cui ultimo periodo mestruale ha avuto luogo meno di un anno prima dello screening, incapaci o riluttanti all'utilizzo di adeguati metodi contraccettivi dall'inizio dello studio fino ad un anno dopo l'ultima dose della terapia da protocollo. Contraccezione adeguata è descritta come controllo ormonale delle nascite, dispositivo intrauterino, metodo a doppia barriera o astinenza totale.
    17) I soggetti maschi incapaci o riluttanti all'utilizzo di adeguati metodi contraccettivi adeguati dall'inizio dello studio fino ad un anno dopo l'ultima dose della terapia da protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (CR+ PR) defined as per Cheson criteria.
    Tasso di risposta globale (risposta completa più risposta parziale, CR+PR) definita secondo i criteri di Cheson.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Response will be evaluated during treatment, at the end of treatment and during follow up.
    La risposta verrà valutata durante il trattamento, alla fine del trattamento e durante il follow up.
    E.5.2Secondary end point(s)
    Toxicities as outlined in NCI-CTCAE
    version 4.03, Duration of response defined for
    patients in CR or PR, Time to Next Treatment,
    progression free survival, overall survival,
    MRD evaluation in FL patients only and
    correlation with PFS and OS.
    Tollerabilità secondo i criteri NCI-CTCAE versione 4.03, durata della risposta definita per i pazienti in CR o PR, tempo al trattamento successivo (TTNT), sopravvivenza libera da progressione, sopravvivenza globale, valutazione di MRD solo nei pazienti con linfoma follicolare e correlazione con PFS e OS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During treatment and follow up.
    Durante il trattamento e il follow up.
    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 concerned31
    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
    The end of the study is defined as the date of the last
    visit of the last patient, including follow up.
    La fine dello studio è definita come la data dell'ultima visita dell'ultimo paziente, incluso il follow up.
    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 months6
    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.1.1.1In 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: 49
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state73
    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)
    Subjects will be treated as per current clinical practice
    I soggetti saranno sottoposti ai trattamenti previsti 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 Decision2013-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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