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    Summary
    EudraCT Number:2012-003392-18
    Sponsor's Protocol Code Number:FIL_RENOIR12
    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:2014-01-27
    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 number2012-003392-18
    A.3Full title of the trial
    A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after chemoimmunotherapy with Rituximab-Bendamustine for relapsed/refractory FL patients not eligible for autologous transplantation (ASCT)
    Studio randomizzato multicentrico di fase III con combinazione di Rituximab e Lenalidomide vs solo Rituximab come terapia di mantenimento dopo chemioimmunoterapia con Rituximab e Bendamustina per pazienti affetti da linfoma follicolare in recidiva/refrattari non elegibili per terapia ad alte dosi seguita da autotrapianto di cellule staminali
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after chemoimmunotherapy with Rituximab-Bendamustine for relapsed/refractory FL patients not eligible for autologous transplantation (ASCT)
    Studio randomizzato multicentrico di fase III con combinazione di Rituximab e Lenalidomide vs solo Rituximab come terapia di mantenimento dopo chemioimmunoterapia con Rituximab e Bendamustina per pazienti affetti da linfoma follicolare in recidiva/refrattari non elegibili per terapia ad alte dosi seguita da autotrapianto di cellule staminali
    A.3.2Name or abbreviated title of the trial where available
    FIL_RENOIR12
    A.4.1Sponsor's protocol code numberFIL_RENOIR12
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    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 pointSecretary
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezia, 16
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.3.4CountryItaly
    B.5.4Telephone number00390131206132
    B.5.5Fax number00390131263455
    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 REVLIMID
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/11/868
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeANTINEOPLASTIC AND IMMUNOMODULATING AGENT
    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
    Maintenance following R-chemotherapy (Rituximab-Bendamustine) of patients with follicular lymphoma in first or second relapse or progression and not eligible for autologous stem cell transplantation (ASCT)
    Mantenimento seguito da R-chemioterapia (Rituximab – Bendamustina) di pazienti con linfoma follicolare in prima o seconda recidiva o in progressione e non eleggibili per terapia ad alte dosi seguita da autotrapianto di cellule staminali (ASCT)
    E.1.1.1Medical condition in easily understood language
    Patients with follicular lymphoma in first or second relapse or progression and not eligible for autologous stem cell transplantation
    Pazienti con linfoma follicolare in prima o seconda recidiva o in progressione e non eleggibili per terapia ad alte dosi seguita da autotrapianto di cellule staminali
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    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 in patients responsive to induction whether the R2-MANT program may improve progression-free survival (PFS) compared to patients treated with R-MANT.
    Valutare nei pazienti responsivi alla terapia di induzione se il programma R2-MANT possa migliorare la progression-free survival (PFS) rispetto ai pazienti trattati con R-MANT.
    E.2.2Secondary objectives of the trial
    To compare in patients respondents to induction the R2-MANT vs the R-MANT program for:
    - Safety, in terms of rate of grade III-IV adverse events.
    - Efficacy, in terms of OS.
    To evaluate the activity of maintenance program on MRD assessed in terms of: rate of conversion to molecular remission, rate of molecular relapse, disease kinetics by real time PCR in the bone marrow (BM) and peripheral blood (PB).
    To assess the prognostic impact of molecular persistence and relapse on PFS and OS.
    To assess quality of life (QoL) at study entry and to compare QoL between study arms at the end of induction and at 6, 12 and 24 months of maintenance , using the EORTC QLQ-C30C questionnaire. To compare the cost-effectiveness of treatment arms by performing a detailed analysis of direct medical costs including chemotherapy, lenalidomide, patient monitoring, management of side effects and relapses through the evaluation of total healthcare costs and QALYs using (EQ-5D) questionnaire.
    Confrontare nei pazienti responsivi al programma di induzione la terapia R2-MANT rispetto alla terapia R-MANT per:
    - Sicurezza, in termini di eventi avversi di grado III-IV
    - Efficacia, in termini di OS.
    Valutare l'attività del programma di mantenimento sulla MRD valutata in termini di: tasso di conversione per la remissione e la recidiva molecolare, la cinetica della malattia osservata in real time PCR nel BM e PB.
    Valutare l’impatto prognostico della persistenza molecolare e della recidiva molecolare su PFS e OS.
    Valutare QoL all’ingresso in studio e confrontare QoL utilizzando il questionario EORTC QLQ-C30C.
    Al fine di comparare il costo-efficacia dei due bracci di trattamento si sviluppa un’analisi dei costi clinici diretti includendo la chemioterapia, il costo della lenalidomide, il monitoraggio del paziente, il management degli effetti collaterali e delle recidive attraverso la valutazione del costi sanitari complessivi e QALYs utilizzando il questionario EQ-5D.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Follicular lymphoma grade I, II and IIIa according to the WHO classification. Availability of archival diagnostic biopsy for histological revision. Rebiopsy at study entry is strongly encouraged but mandatory only in case of suspected transformation (elevated LDH or rapidly-growing disease or unusual relapse presentation) or if archival diagnostic biopsy is not available.
    - First or second relapse or progression following R-chemotherapy (Rituximab maintenance and IF radiotherapy are not considered treatment lines).
    - Patients not eligible for more curative approaches i.e high dose chemotherapy and ASCT.
    - Age >18 years.
    - Stage II, III or IV according to Ann Arbor at relapse.
    - Need of treatment according to SIE-SIES-GITMO guidelines for follicular lymphoma: stage II-IV with systemic symptoms, high tumor burden (i.e. >3 lymph nodes measuring >3 cm or a single lymph node >7 cm), extranodal disease, cytopenia due to marrow involvement, spleen involvement (≥16 cm by CT), leukemic phase, serious effusion, symptomatic or life endangering organ involvement, rapid lymphoma progression, consistently increased LDH levels.
    - Must be able to adhere to the study visit schedule and other protocol standards.
    - ECOG performance status ≤ 2 (except when PS impairment is related to lymphoma).
    - Be willing and able to comply with the protocol for the duration of the study.
    - Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L unless due to marrow involvement by lymphoma; and platelets count ≥ 75 x 109/L unless due to marrow involvement by lymphoma.
    - Calculated creatinine clearances ≥ 40 ml/min.
    - Agree to be using effective contraception for the entire treatment period according to standard guidelines for patients receiving lenalidomide.
    - Diagnosi istologica di Linfoma Follicolare di grado I, II e IIIa secondo la classificazione WHO. Si richiede la disponibilità del materiale bioptico diagnostico per revisione istologica. La ri-biopsia del paziente all’ingresso in studio è fortemente raccomandata ma mandatoria solo in caso di sospetta trasformazione (elevato LDH o rapida crescita della malattia o inusuale presentazione della recidiva) o se il materiale bioptico archiviato non è disponibile.
    - Prima o seconda recidiva o progressione dopo regime di R-chemotherapia (mantenimento con Rituximab e radioterapia IF non sono considerate linee di trattamento).
    - Pazienti non eleggibili ad approcci maggiormente curativi i.e chemioterapia ad alte dosi e ASCT.
    - Età >18 years.
    - Stadio II, III o IV secondo la classificazione di Ann Arbor alla recidiva.
    - Necessità di trattamento in conformità con le line guida SIE-SIES-GITMO per il linfoma follicolare: stadio II-IV con sintomi sistemici, alto tumor burden (i.e. >3 sedi nodali con dimensione >3 cm o singola sede nodale >7 cm), coinvolgimento extranodale, citopenia dovuta ad infiltrazione midollare, coinvolgimento splenico (≥16 cm alla CT), leucemizzazione, versamenti membrane sierose (pleura, pericardio e peritoneo), danno organico da compressione o infiltrazione, rapida progressione del linfoma, incremento costante dei valori di LDH.
    - Capacità di aderire al programma di visite e agli standard previsti dal protocollo.
    - ECOG performance status ≤ 2 (eccetto quando la riduzione del PS è correlata al linfoma).
    - Compliance al protocollo per l’intera durata dello studio.
    - Neutrofili in valore assoluto (ANC) ≥ 1.5 x 10 9/L eccetto se a causa di infiltrazione midollare da linfoma; e piastrine ≥ 75 x 109/L eccetto se a causa di infiltrazione midollare da linfoma.
    - Ceatinina clearances ≥ 40 ml/min.
    - Compliance all’uso di metodi contraccettivi efficaci per tutta la durata dello studio ed in accordo alle linee guida standard per pazienti in cura con Lenalidomide
    E.4Principal exclusion criteria
    - Any lymphoma subtype other than FL including transformed FL
    - Grade 3b follicular lymphoma.
    - Radiotherapy within 3 months prior to study entry
    - Subjects regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 10 mg/day prednisone (over these 4 weeks).
    - Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
    - HIV positive serology. HBV and HCV positive patients will be not excluded from the study if the hepatic enzymes are within the ranges later defined. HBV positive patients will be given lamivudine as prophylaxis starting one week before chemotherapy. HbsAg, HBcAb, HBV-DNA and HCV-RNA levels will be monitored twice every month in HCV or HBV positive patients.
    - Life expectancy < 6 months.
    - Known sensitivity or allergy to murine products.
    - Prior history of malignancies, other than follicular lymphoma, unless the subject has been free of the disease for > 3 years with the exception of adequately cured localized non-melanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast or incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
    - Prior use of lenalidomide.
    - Neuropathy > Grade 1.
    - Myocardial infarction within the last 6 months
    - Presence or history of CNS involvement by lymphoma.
    - Subjects who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis.
    - Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) > 3x upper limit of normal (ULN), except in subjects with documented liver involvement by lymphoma
    - Total bilirubin > 2.0 mg/dl (34 umol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma
    - Uncontrolled intercurrent illness.
    - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
    - Pregnant or lactating females.
    - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.
    - Istologia diversa da quella descritta precedentemente (compreso LF trasformato)
    -LF di Grado IIIb
    - Radioterapia effettuata entro 3 mesi dall’inclusione nello studio
    - Soggetti che assumono regolarmente corticosteroidi durante le ultime 4 settimane, a meno che non somministrata una dose equivalente < 10 mg/giorno di prednisone (durante le 4 settimane precedenti).
    - Interventi chirurgici (escludendo la biopsia del linfonodo) entro 28 giorni prima della registrazione.
    - Sierologia positiva per HIV. I pazienti positivi a HBV e HCV non sono esclusi dello studio se gli enzimi epatici sono compresi tra gli intervalli definiti sotto. I pazienti HBV positivi saranno trattati con lamivudine come profilassi iniziando una settimana prima della chemioterapia. I livelli di HbsAg, HBcAb, HBV-DNA e HCV-RNA saranno monitorati due volte al mese nei pazienti HCV o HBV positivi.
    - Aspettativa di vita < 6 mesi.
    - Conosciuta ipersensibilità o allergia alle murine.
    - Precedente storia di neoplasia, differente da linfoma follicolare, a meno che il soggetto non sia libero da malattia da almeno 3 anni con l’eccezione dei tumori cutanei localizzati non melanomi adeguatamente trattati, carcinoma in situ della cervice, carcinoma in situ della mammella o cancro alla prostata di rilevazione istologica accidentale (TNM stage of T1a or T1b)
    - Precedente utilizzo della lenalidomide.
    - Neuropatia > Grado 1.
    - Infarto del miocardio negli ultimi 6 mesi.
    - Presenza o storia di coinvolgimento del CNS da linfoma.
    - Soggetti ad alto rischio trombotico e che non disposti ad assumere una profilassi venosa trombotica (VTE).
    - Aspartato transaminasi (AST/SGOT) o Alanina transaminasi (ALT/SGPT) > 3 volte sopra i limiti superiori di normalità (ULN), eccetto nei soggetti con documentato coinvolgimento epatico da linfoma.
    - Bilirubina totale > 2.0 mg/dl (34 umol/L) eccetto nei casi di syndrome di Gilberts e documentato coinvolgimento epatico da linfoma.
    - Condizioni cliniche instabili
    - Qualsiasi condizione clinica seria, anomalia di laboratorio o patologia psichiatrica che può impedire al soggetto la firma del consenso informato
    - Donne in stato di gravidanza o durante il periodo di allattamento
    - Qualsiasi condizione, incluse le anomalie di laboratorio che espongono il soggetto ad un rischio inaccettabile se decidesse di partecipare allo studio, o che possa compromettere la corretta interpretazione dei dati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the Progression-free Survival. PFS will be measured from the date of randomisation to the date of documented first occurrence of disease progression or relapse or to the date of death from any cause. Patients without events considered and patients who are lost to follow up will be censored at their last assessment date.
    L'endpoint primario è la sopravvivenza libera da progressione. La PFS sarà misurata dalla data di randomizzazione alla data di prima occorrenza di progressione della malattia o recidiva o alla data di morte per qualsiasi causa. I pazienti senza eventi considerati ed i pazienti che si sono persi al follow-up saranno censurati secondo la loro ultima data di valutazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    - OS will be measured from the date of randomisation and from enrolment to the date of death from any cause. Patients who have not died at the time of the final analysis will be censored at the date of the last contact.
    - PFS will be measured from the date of enrolment to the date of documented first occurrence of disease progression or relapse or to the date of death from any cause. Patients without events considered and patients who are lost to follow up will be censored at their last assessment date.
    - Toxicity will be classified according to definitions of Common Terminology Criteria for Adverse Event version 4.03 (CTCAE). It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions).
    - Rate of molecular remission will be defined as the proportion of patients PCR negative for Bcl-2/IgH at different time-points including those achieving continuous MR in two or more consecutive time-points.
    - Rate of molecular conversion will be defined as the proportion of patients from baseline PCR-positivity to PCR-negativity.
    - Rate of molecular relapse will be defined as the proportion of patients from PCR-negativity to PCR-positivity.
    - QoL will be measured at the baseline, the end of induction and at 6, 12 and 24 months of maintenance through the EORTC QLQ-C30 questionnaire.
    - The incremental cost-effectiveness ratio (ICER) will be calculated by dividing the difference in mean total costs between the two arms by the difference in the mean effects. The ICER will be calculated for the primary clinical effect measures of the trial. (i.e. PFS) and for QALYs. QALYs will be calculated multiplying the amount of time a patient spent in a particular health state by the utilities estimated using the Euro-Qol (EQ-5D) questionnaire.
    - OS sarà misurata a partire dalla data di randomizzazione e dalla iscrizione alla data di morte per qualsiasi causa. I pazienti che non sono morti al momento dell'analisi finale saranno censurati alla data dell'ultimo contatto .
    - PFS sarà misurata a partire dalla data di iscrizione alla data della documentata prima occorrenza di progressione della malattia o recidiva o alla data di morte per qualsiasi causa. I pazienti senza eventi considerati ed i pazienti che si sono persi al follow-up saranno censurati nella loro ultima data di valutazione .
    - Tossicità sarà classificata secondo le definizioni di CTCAE v. 4.03 . Sarà determinata dall'incidenza di gravità, dal pericolo di vita ( CTCAE di grado 3 , 4 e 5 ) e / o dagli eventi avversi gravi (reazioni correlate all'infusione ) .
    - Tasso di remissione molecolare sarà definito come la percentuale di pazienti PCR negativo per bcl-2/IgH in diversi punti temporali compresi quelli dove la MR è in due o più punti consecutiva .
    - Tasso di conversione molecolare sarà definita come la percentuale di pazienti al basale PCR-positività della PCR-negatività .
    - Tasso di recidiva molecolare sarà definita come la percentuale di pazienti che mutano dalla PCR- negatività alla PCR- positività .
    - QoL sarà misurato al basale, la fine di induzione e alle 6, 12 e 24 mesi di manutenzione attraverso il questionario EORTC QLQ - C30 .
    - Il rapporto costo-efficacia incrementale ( ICER ) sarà calcolato dividendo la differenza dei costi totali medi tra i due bracci valutando la differenza negli effetti medi. L' ICER sarà calcolato per le misure di efficacia clinica primaria dello studio . ( ossia PFS) e per QALY . QALY verranno calcolati moltiplicando la quantità di tempo che un paziente trascorso in un particolare stato di salute utilizzando il questionario Euro - Qol ( EQ ​​- 5D )
    E.5.2.1Timepoint(s) of evaluation of this end point
    64 months
    64 months
    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) 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 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) Yes
    E.8.2.2Placebo No
    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 concerned50
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 213
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state253
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of participation in the study patients will be followed as required by standard practice.
    Al termine della partecipazione allo studio i pazienti verranno seguiti secondo quanto previsto dalla comune 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 Decision2014-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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