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    Summary
    EudraCT Number:2012-003170-60
    Sponsor's Protocol Code Number:FIL_FOLL12
    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:2012-08-02
    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 number2012-003170-60
    A.3Full title of the trial
    A multicenter, phase III, randomized study to evaluate the efficacy of a response-adapted strategy to define maintenance after standard chemoimmunotherapy in patients with advanced-stage Follicular Lymphoma
    Studio multicentrico, randomizzato di fase III per valutare l'efficacia di una strategia di mantenimento modulata sulla base della risposta al trattamento di induzione con chemioimmunoterapia standard in pazienti con Linfoma Follicolare in stadio avanzato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, phase III, randomized study to evaluate the efficacy of a response-adapted strategy to define maintenance after standard chemoimmunotherapy in patients with advanced-stage Follicular Lymphoma
    Studio multicentrico, randomizzato di fase III per valutare l’efficacia di una strategia di mantenimento modulata sulla base della risposta al trattamento di induzione con chemioimmunoterapia standard in pazienti con Linfoma Follicolare in stadio avanzato.
    A.3.2Name or abbreviated title of the trial where available
    FIL_FOLL12
    FIL_FOLL12
    A.4.1Sponsor's protocol code numberFIL_FOLL12
    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 supportFondazione Italiana Linfomi ONLUS
    B.4.2CountryItaly
    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 pointSegreteria Amminstrativa
    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 number0131/206261
    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 ZEVALIN*INFUS 1F 2ML 1,6MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER SpA
    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 Injection
    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 INNYTTRIUM (90Y) IBRITUMOMAB TIUXETAN
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB30555
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/kg millicurie(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number.4
    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 Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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.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.3.4Pharmaceutical form 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 INNCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.1CAS number 6055-19-2
    D.3.9.4EV Substance CodeSUB16414MIG
    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.IMP: 3
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 25316-40-9
    D.3.9.4EV Substance CodeSUB01827MIG
    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.IMP: 4
    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.3.4Pharmaceutical form Solution for injection
    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 INNVINCRISTINE SULFATE
    D.3.9.1CAS number 2068-78-2
    D.3.9.4EV Substance CodeSUB05101MIG
    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.IMP: 5
    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.3.4Pharmaceutical form Tablet
    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 INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.9.4EV Substance CodeSUB10020MIG
    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.IMP: 6
    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.3.4Pharmaceutical 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    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) Yes
    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
    Previously untreated intermediate-high risk according to the FLIPI2 stage II-IV follicular lymphoma requiring therapeutic intervention.
    Pazienti con linfoma follicolare in stadio II-IV, a rischio intermedio-alto secondo il FLIPI2, non precedentemente trattati.
    E.1.1.1Medical condition in easily understood language
    Previously untreated intermediate-high risk according to the FLIPI2 stage II-IV follicular lymphoma requiring therapeutic intervention.
    Pazienti con linfoma follicolare in stadio II-IV, a rischio intermedio-alto secondo il FLIPI2, non precedentemente trattati.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10061170
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 whether a PET and MRD response-based maintenance therapy is more effective in terms of Progression-Free Survival (PFS) than a standard maintenance therapy with Rituximab in patients with untreated, advanced, follicular lymphoma.
    Valutare, in termini di Progression Free Survival (PFS), se una terapia di mantenimento basata sulla risposta alla PET e sulla valutazione della malattia minima residua è più efficace rispetto ad una terapia di mantenimento standard con Rituximab in pazienti con nuova diagnosi di linfoma follicolare in stadio avanzato.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of maintenance with observation or pre-emptive Rituximab therapy administered on the basis of MRD status and the efficacy of a standard maintenance for 2 years in patients at low risk of progression after induction chemoimmunotherapy. To evaluate the efficacy of intensified maintenance with (90)Y Ibritumomab Tiuxetan followed by Rituximab maintenance therapy and the efficacy of a standard maintenance for 2 years in patients at high risk of progression after induction chemoimmunotherapy. To compare a response-based maintenance therapy with a standard maintenance therapy in terms of toxicity. To verify the predictive value of MRD detection. To perform a cross evaluation of the predictive value of MRD analysis and FDG-PET.
    Valutare l’efficacia di un mantenimento con sola osservazione o con terapia pre-emptive con Rituximab Valutare l’efficacia di un mantenimento intensificato con (90)Y Ibritumomab Tiuxetan seguito da Rituximab e l’efficacia di un trattamento standard con Rituximab ogni 2 mesi per 2 anni in pazienti ad alto rischio di progressione dopo induzione standard con chemioimmunoterapia Valutare la tossicità di un mantenimento standard e di un mantenimento modulato in base alla risposta clinica e molecolare. Verificare il valore predittivo della valutazione della malattia minima residua su sangue midollare e periferico Eseguire una valutazione incrociata del valore predittivo dello stato della malattia minima residua (MMR) e della risposta determinata con la PET.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histological diagnosis of B-Cell CD20+ Follicular Lymphoma (FL), grade I, II, IIIa according to the WHO 2008 classification • ECOG performance status 0-2 • Age ≥ 18 years • Ann Arbor stage II-IV • FLIPI2>0 • Presence of evaluable/measurable disease after diagnostic biopsy • At least one of the following criteria for defining active disease: - systemic symptoms - cytopenia due to bone marrow involvement - LDH> upper normal value - any nodal or extranodal tumor mass with a diameter >7cm - involvement of ≥ 3 nodal sites, each with a diameter of ≥ 3cm - extranodal disease - rapidly progressive disease • Life expectancy > 6 months • Left ventricular ejection fraction (LVEF)  50% • Serum negativity for HIV • Serum negativity for HBsAg; HBcAb positive but HBV-DNA negative patients are allowed with mandatory Lamivudine prophylaxis. • Serum negativity for HCV, except for those patients without signs of active viral replication assessed by HCV-RNA copies • Serum creatinine < 2mg/dl , serum bilirubin < 1.5mg/dl, aspartate amino-transferase (AST/GOT)  2.5xUNV, alanine amino-transferase (ALT/GPT)  2.5xUNV, and alkaline phosphatase  4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator) • Patients with no previous treatment for the lymphoma with the exception of locoregional radiotherapy (IF-RT) • Adequate measure adoption to avoid pregnancy • Written informed consent given at time of registration • Patient must be accessible for treatment and follow up
    • Diagnosi istologica di linfoma follicolare a cellule B, CD20+, di grado I, II, IIIa (sec.WHO 2008) • ECOG performance status 0-2 • Età ≥ 18 anni • Stadio II-IV, secondo Ann Arbor • FLIPI2&gt;0 • Presenza di malattia misurabile e/o valutabile dopo biopsia diagnostica • Presenza di almeno uno dei seguenti criteri di malattia attiva: -sintomi sistemici B -citopenia conseguente ad infiltrazione midollare -LDH&gt; valore normale -massa nodale o extranodale con diametro &gt;7cm -coinvolgimento di 3 o più sedi nodali ognuna delle quali con diametro ≥ 3cm -malattia extranodale -rapida progressione della malattia • Aspettativa di vita &gt; 6 mesi • Frazione di eiezione ventricolare (LVEF)  50% • Negatività sierica per HIV • Negatività sierica per HBsAg; i pazienti HBcAb positivi ma HBV-DNA negativi possono essere arruolati (la profilassi con lamivudina è obbligatoria). • Negatività sierica per HCV, eccetto per i pazienti senza segni di replicazione virale (HCV-RNA negativi) • Normale funzionalità epatica (bilirubina &lt; 1.5mg/dl, aspartato amino-transferasi (AST/GOT)  2.5 volte il limite superiore normale, alanina amino-transferasi (ALT/GPT)  2.5 volte il limite superiore normale, fosfatasi alcalina  4 volte il limite superiore normale) e renale (creatinina &lt; 2mg/dl). Sono ammessi valori superiori solo se tali alterazioni sono determinate dalla presenza del linfoma. • Nessun precedente trattamento per linfoma ad eccezione della radioterapia locoregionale (IF-RT) • Utilizzo di adeguati metodi contraccettivi in pazienti di età fertile, sia di sesso femminile che maschile • Consenso informato scritto prima della registrazione • Disponibilità del paziente ad essere seguito per tutte le fasi del trattamento chemioterapico e per il successivo follow-up
    E.4Principal exclusion criteria
    • Histological diagnosis of : -any lymphoma other than follicular lymphoma and all CD20 negative B-cell lymphomas -grade III b follicular lymphoma -evidence of transformation to high grade lymphoma • Ann Arbor stage I • Suspect or clinical evidence of CNS involvement by lymphoma • History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer, low grade, early stage localized prostate cancer treated surgically with curative intent, good prognosis DCIS of the breast treated with lumpectomy alone with curative intent • Evidence of any severe active acute or chronic infection • Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy • Severe chronic obstructive pulmonary disease with hypoxemia • Severe diabetes mellitus difficult to control with adequate insulin therapy • Myocardial infarction within 6 months before study entry • Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure >115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV • HbsAg-positive, HIV-positive, or HCVAb-positive patients • Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins • Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent • Follicular lymphoma, showing a negative baseline PET scan
    • Diagnosi istologica di: -qualsiasi tipo di linfoma diverso da linfoma follicolare o linfoma CD20- -linfoma follicolare di grado IIIb -evidenza di trasformazione in linfoma ad alto grado • Stadio I secondo Ann Arbor • Coinvolgimento del sistema nervoso centrale da parte del linfoma • Storia di patologie tumorali nei 5 anni precedenti all’entrata nello studio, ad eccezione di: carcinoma in situ della cervice uterina, carcinoma basale o squamoso della cute, carcinoma prostatico localizzato trattato chirurgicamente con intento curativo e carcinoma duttale in situ trattato con lumpectomia • Evidenza di gravi infezioni acute o croniche • Patologie concomitanti che possono impedire la somministrazione dei farmaco a dose piena • Malattia polmonare ostruttiva cronica associate ad ipossiemia • Diabete mellito difficilmente controllabile con adeguata terapia insulinica • Infarto miocardico nei 6 mesi precedenti all’entrata nello studio • Patologia cardiaca secondaria clinicamente significativa (ipertensione non controllata (pressione diastolica &gt;115 mmHg), aritmia cardiaca multifocale non controllata, angina pectoris sintomatica o scompenso cardiaco congestizio (NYHA classi III-IV) • Positività per HbsAg, HIV o HCVAb • Ipersensibilità nota o reazioni anafilattiche ad anticorpi o proteine murine • Altre condizioni mediche o psicologiche che possono interferire con la partecipazione del paziente allo studio clinico o compromettere la capacità di dare il proprio consenso • Linfoma follicolare con PET negativa all’esordio
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) defined as the time from entry onto the study until lymphoma progression or death as a result of any cause.
    la sopravvivenza libera da progressione (PFS) definita come l’intervallo di tempo dall’entrata nello studio fino a progressione del linfoma o alla morte per qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    the time from entry onto the study until lymphoma progression or death
    l’intervallo di tempo dall’entrata nello studio fino a progressione del linfoma o alla morte
    E.5.2Secondary end point(s)
    overall survival (OS), overall response rate (ORR), duration of remission (DR) and event free survival (EFS). Molecular response evaluated by PCR assessment of Bcl2/IgH rearrangement
    sopravvivenza globale (OS), risposta globale (ORR), durata di remissione (DR) e sopravvivenza libera da eventi (EFS). Risposta molecolare definita mediante valutazione del riarrangiamento genico Bcl-2/IgH
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Fine dello 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 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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned49
    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 years7
    E.8.9.1In the Member State concerned months0
    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.1.1Number of subjects for this age range: 0
    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: 202
    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 state602
    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, the 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 Decision2012-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-25
    P. End of Trial
    P.End of Trial StatusOngoing
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