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    Summary
    EudraCT Number:2011-001421-24
    Sponsor's Protocol Code Number:FIL_R-BENDAFRAIL
    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:2011-12-21
    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 number2011-001421-24
    A.3Full title of the trial
    Rituximab plus Bendamustine as front line treatment in frail elderly (≥70 years) patients with diffuse large B-cell non-Hodgkin’s lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi (FIL)
    Combinazione Rituximab-Bendamustina per il trattamento di I linea in soggetti anziani (≥70 anni) ''fragili'' affetti da Linfoma non Hodgkin a grandi cellule B: studio multicentrico di fase II della Fondazione Italiana Linfomi (FIL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rituximab plus Bendamustine as front line treatment in frail elderly (≥70 years) patients with diffuse large B-cell non-Hodgkin’s lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi (FIL)
    Combinazione Rituximab-Bendamustina per il trattamento di I linea in soggetti anziani (≥70 anni) “fragili” affetti da Linfoma non Hodgkin a grandi cellule B: studio multicentrico di fase II della Fondazione Italiana Linfomi (FIL)
    A.3.2Name or abbreviated title of the trial where available
    FIL_R-BENDA FRAIL
    FIL_R-BENDA FRAIL
    A.4.1Sponsor's protocol code numberFIL_R-BENDAFRAIL
    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 supportMundipharma
    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 Amministrativa
    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 number0131/206071
    B.5.5Fax number0131/261029
    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.2.1.2Country 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) 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 typeAnticorpo monoclonale
    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 Ribomustin
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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
    D.3.9.1CAS number 16506-27-7
    D.3.9.4EV Substance CodeSUB05707MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 typeAgente Alchilante
    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
    Patients with diffuse large B-cell non-Hodgkin’s lymphoma in frail elderly (≥70 years) patients
    Pazienti affetti da linfoma non Hodgkin a grandi cellule B in soggetti anziani (≥70 anni) “fragili”
    E.1.1.1Medical condition in easily understood language
    Diffuse large B-cell non-Hodgkin’s lymphoma in frail elderly (≥70 years) patients
    Linfoma non Hodgkin a grandi cellule B in soggetti anziani (≥70 anni) “fragili”
    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 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    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 the activity of R-B combination in terms of complete response rate (CRR). •To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.
    •Valutare l’efficacia della combinazione Rituximab-Bendamustina in termini di percentuale di risposta completa (CR) •Valutare la tossicità e la tollerabilità della combinazione Rituximab-Bendamustina in termini di percentuale di eventi avversi
    E.2.2Secondary objectives of the trial
    •To evaluate progression free survival (PFS). •To evaluate overall survival (OS).
    •Valutare il tempo libero da progressione (PFS). •Valutare la sopravvivenza globale (OS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically proven CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma •Age ≥ 70 years •No previous treatment •FRAIL patients defined as follows (see Appendices B-E of the protocol): Age > 80 years with UNFIT profile, i.e. oADL > 5 residual functions oIADL > 6 residual functions oCIRS 5-8 co-morbidities of grade 2 or Age < 80 years with oADL < 4 residual functions, or oIADL < 5 residual functions, or oCIRS : 1 co-morbidity of grade 3-4, or > 8 co-morbidities of grade 2 •Life expectancy > 6 months •Written informed consent •Accessibility of patient for treatment and follow up
    •Diagnosi istologica di DLBCL CD20+ secondo la REAL/WHO. •Età ≥ 70 anni. •Malattia non precedentemente trattata. •Paziente definito “fragile” sulla base delle seguenti caratteristiche (CGA): Età ≥ 80 anni e ADL ≥ 5 funzioni residue; IADL ≥ 6 funzioni residue; CIRS 5-8 comorbidità di grado 2; oppure Età &lt; 80 anni e ADL ≤ 4 funzioni residue; IADL ≤ 5 funzioni residue; CIRS: 1 comorbidità di grado 3-4, o &gt; 8 comorbidità di grado 2. • Aspettativa di vita &gt; 6 mesi. • Consenso informato scritto • Paziente accessibile per il trattamento e per il follow-up
    E.4Principal exclusion criteria
    •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 •Previous exposure to cytotoxic agents •Suspect or clinical evidence of CNS involvement by lymphoma •HBsAg, HCV or HIV positivity; HBcAb positivity is accepted only with concomitant treatment with Lamivudine •AST /ALT > twice upper the normal range; bilirubin > twice upper the normal range; serum creatinine > 2.5 mg /dl •Evidence of any severe active acute or chronic infection •Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy •Senile dementia •Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
    •Storia clinica di altre neoplasie nei 5 anni precedenti l’entrata in studio, fatta eccezione per il carcinoma in situ della cervice uterina o il carcinoma cutaneo basale o a cellule squamose adeguatamente trattati ed eradicati •Precedenti trattamenti con farmaci citotossici •Sospetto o evidenza clinica di coinvolgimento del SNC da parte del linfoma •HBsAg, HCV o HIV positività; pazienti HBcAb positivi possono essere inclusi dopo profilassi con Lamivudina •AST /ALT &gt; 2 x ULN; bilirubina &gt; 2 x ULN; creatinina &gt; 2.5 mg /dl •Presenza di infezione acuta o cronica in atto di qualsiasi natura (batterica, virale o fungina) •Presenza di malattie concomitanti che precludano la somministrazione del trattamento a dosi piene •Demenza senile o qualsiasi altra condizione fisica o psicologica che preclude la partecipazione del paziente allo studio o che ne comprometta la capacità di fornire un consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy of R-Bendamustin measured by Complete Response rate. Complete response rate will be evaluated according to Cheson criteria; Cheson 1999 criteria will be used for response evaluation on CT-scan; in the case of PET availability, response will be assessed on PET according to the Cheson 2007 criteria.
    L'efficacia di R-Bendamustina sarà misurata dal tasso di risposta completa. Tasso di risposta completa sarà valutato secondo i criteri di Cheson; I criteri saranno utilizzati per la valutazione della risposta alla TC-scan, nel caso di disponibilità di PET, la risposta sarà valutata sulla PET secondo i criteri Cheson 2007.
    E.5.1.1Timepoint(s) of evaluation of this end point
    32 weeks from beginning of treatment
    32 settimane dopo l'inizio del trattamento
    E.5.2Secondary end point(s)
    2-year Progression free survival (PFS), defined as the time from entry into the study until lymphoma relapse/ progression or death as a result of any cause. Responding patients, patients who are lost to follow up, who withdrawal the consent or drop-out due to adverse event will be censored at their last assessment date. Patients died due to tumor will be considered in progression. Patients died for any other cause will be censored to the death date. 2-year Overall survival (OS), defined as the time from the date of treatment start into the study until the date of death irrespective of cause. Patients who have not died at the time of end of the whole study, and patients who are lost to follow up, will be censored at the date of the last contact The complete response rate will be estimated with the 95% confidence interval. Time to event data (PFS, OS) will be estimated using the Kaplan-Meier method.
    2 anni di sopravvivenza libera da progressione (PFS), definito come il tempo tra l'entrata in studio fino a quando il linfoma recidiva / progressione o morte come conseguenza di qualsiasi causa. Pazienti che hanno risposto, i pazienti che sono persi al follow up, che il ritiro del consenso o drop-out a causa di eventi avversi saranno censurati alla loro data di valutazione scorso. Pazienti sono deceduti per tumore saranno considerati in progressione. Pazienti sono morti per altre cause saranno censurati alla data della morte.  2 anni di sopravvivenza globale (OS), definito come il tempo dalla data di inizio trattamento in studio fino alla data di morte indipendentemente dalla causa. I pazienti che non sono deceduti al termine dello studio ed i pazienti persi al follow up, saranno censiti alla data dell'ultimo contatto. Il tasso di risposta completa verrà stimata con l'intervallo di confidenza al 95%. Le variabili di tempo PFS ed OS saranno stimate utilizzando il metodo Kaplan-Meier.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years from beginning of treatment
    2 anni dall'inizio del 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 years4
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 49
    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 state49
    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)
    The usual treatments provided good clinical practice
    Le normali cure previste dalla buona 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 Decision2012-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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