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    Summary
    EudraCT Number:2011-003495-36
    Sponsor's Protocol Code Number:S10BEOF01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-003495-36
    A.3Full title of the trial
    A multicenter pilot phase II study for the preliminary evaluation of feasibility, activity and safety of the administration of Bendamustine and Ofatumumab in combination in marginal zone B-cell lymphomas (MZL)
    Studio multicentrico pilota di fase II per la valutazione preliminare della fattibilita', attivita' e tollerabilita' della somministrazione della combinazione ofatumumab e bendamustina in pazienti affetti da linfoma B marginale (MZL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter preliminary study to evaluate activity and safety of the combination of drugs ofatumumab and bendamustine in patients with marginal zone B-cell lymphomas
    Studio preliminare che si svolge in piu' centri per la valutazione dell'attivita' e della tollerabilita' del farmaco ofatumumab somministrato col farmaco bendamustina in pazienti affetti da linfoma B marginale
    A.4.1Sponsor's protocol code numberS10BEOF01
    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 SponsorSENDO TECH
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGruppo GSK per ofatumumab
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportMundipharma per bendamustina
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSENDO-TECH Srl
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressVia Visconti di Modrone, 12
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 7642041
    B.5.5Fax number+39 02 76017484
    B.5.6E-maildepascalea@sendo-org.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, Glaxo Wellcome House, Greenford, Middlesex
    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/3/08/581
    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.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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.2.1.1.1Trade name Ribomustin
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma Medical Company, Basel
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 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 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 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
    marginal zone B-cell lymphomas (MZL)
    linfoma marginale di tipo B
    E.1.1.1Medical condition in easily understood language
    marginal zone B-cell lymphomas (MZL)
    linfoma marginale di tipo B
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029463
    E.1.2Term Nodal marginal zone B-cell lymphoma recurrent
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10029464
    E.1.2Term Nodal marginal zone B-cell lymphoma refractory
    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 efficacy (Overall Remission Rate) of ofatumumab and bendamustine in relapsed or refractory marginal zone B-cell lymphomas
    Valutare la percentuale di risposta (Overall Remission Rate, ORR) della combinazione bendamustina e ofatumumab in pazienti con linfoma marginale di tipo B refrattario o ricaduto
    E.2.2Secondary objectives of the trial
    - Duration of antitumor activity - Safety profile - Feasibility of the combination
    - Durata dell'attività antitumorale - Profilo di sicurezza - Fattibilità della combinazione
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > 18 2. Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory following at least 1 prior systemic treatment (chemotherapy and/or monoclonal antibodies) 3. Any stage (Ann Arbor I-IV) 3. Life expectancy of at least 6 months and ECOG performance status 0-1 4. No evidence of histological transformation to diffuse large cells lymphoma 5. Adeguate bone marrow function, renal function or liver function 6. Signed informed consent
    • Età &gt; 18 anni • Istologia di linfoma marginale a cellule B refrattario o ricaduto dopo almeno un precedente trattamento sistemico (chemioterapia o anticorpi monoclonali). • Aspettativa di vita di almeno 6 mesi ed ECOG performance status 0-1 • Nessuna evidenza di trasformazione istologica a linfoma diffuso a grandi cellule • Adeguata funzionalità renale, midollare ed epatica • Firma del consenso informato
    E.4Principal exclusion criteria
    1. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment 2. Treatment with anti-CD20 monoclonal antibody or alemtuzumab within 8 weeks prior to the enrollment 3. Treatment with corticosteroids during the last 4 weeks 4.Other past or current malignancy 5. Previous organ transplantation 6.Clinically significant cardiac or pulmonary disease 7.History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequele 8. Concomitant infectious diseases, HIV positive, Hepatitis B or C positive.
    • Altro trattamento sperimentale nelle 4 settimane prima dell’arruolamento • Trattamento con un anticorpo monoclonale anti-CD20 o alemtuzumab entro le ultime 8 settimane • Trattamento con corticosteroidi nelle ultime 4 settimane • Presenza di altre patologie tumorali • Precedente trapianto d’organo • Malattia cardiaca o polmonare clinicamente rilevanti • Malattie cerebrovascolari nei precedenti 6 mesi o presenti al momento dell’arruolamento con sintomi o sequelae • Infezioni concomitanti, positività HIV, positività e epatite B o C
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (CR+PR), defined according to Cheson criteria (Cheson et al 2007). For patients with splenic MZL response is defined according to Matutes et al. 2008 and for patients with gastric lymphomas histological response is evaluated according to GELA scoring system (Copie-Bergman et al 2003)
    Tasso di risposta complessivo (ORR = CR+PR), secondo i criteri di Cheson (Cheson et al 2007). Per i pazienti con MZL della milza la risposta è definita secondo Matutes et al. 2008 e per i pazienti con linfoma gastrico la risposta istologica è valutata secondo il GELA scoring system (Copie-Bergman et al 2003)
    E.5.1.1Timepoint(s) of evaluation of this end point
    CT-scan at the end of cycle 2 and at F-up 1 (4 mos), F-up 2 (8 mos) e F-up 3 (24 mos) after the end of treatment.
    Valutazione radiologica (CT-scan) alla fine del secondo ciclo e ai F-up 1 (4 mesi), F-up 2 (8 mesi) e F-up 3 (24 mesi) dalla fine del trattamento.
    E.5.2Secondary end point(s)
    - Two years Progression Free Survival (PFS) - Time to next treatment - Adverse events according to NCI-CTC V3
    - Sopravvivenza libera da progressione (PFS) a 2 anni - Tempo mediano alla successiva terapia - Durata mediana della risposta - Eventi avversi secondo NCI-CTC V3
    E.5.2.1Timepoint(s) of evaluation of this end point
    - PFS: 2 years after the end of the treatment. - Time to next treatment. - Time to relapse. - Continuous evaluation of AE.
    - Due anni dalla fine del trattamento per la valutazione della sopravvivenza. - Tempo al quale si rende necessaria una nuova terapia. - Tempo al quale si manifesta la ricaduta (o progressione o morte per qualunque causa) - Rilevazione continua durante l'intero studio per gli eventi avversi.
    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 concerned6
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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 years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    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.1.1Number 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 15
    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)
    according to current clinical practice
    secondo la normale pratica clinica
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation IELSG, International Extranodal Lymphoma Study Group
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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