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    Summary
    EudraCT Number:2010-023407-95
    Sponsor's Protocol Code Number:MO25455
    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:2012-01-24
    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 number2010-023407-95
    A.3Full title of the trial
    A randomized study comparing maintenance therapy with
    subcutaneous rituximab continued until progression with observation only in patients with relapsed or refractory, indolent non-Hodgkin’s lymphoma who completed and responded to rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
    Studio randomizzato per confrontare la terapia di mantenimento con rituximab per via sottocutanea somministrata continuativamente fino alla progressione con la sola osservazione, in pazienti con linfoma non-Hodgkin indolente recidivato o refrattario, che hanno completato e risposto all`™induzione con l`™immunochemioterapia a base di rituximab e alla terapia iniziale di mantenimento di 2 anni con rituximab per via sottocutanea.
    A.4.1Sponsor's protocol code numberMO25455
    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 SponsorROCHE
    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 supportHoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationROCHE S.P.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressViale G.B. Stucchi 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039 247 5070
    B.5.5Fax number039 247 5085
    B.5.6E-mailsergio.scaccabarozzi@roche.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namerituximab/rHuPH20 SC
    D.3.2Product code RO0452294/F04
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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.3.9.2Current sponsor codeRO0452294
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1400
    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 Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale ricombinante umanizzato
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale ricombinante umanizzato
    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 relapsed or refractory CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma), according to the WHO classification system, or other not further classified low malignant lymphoma by immunohistochemistry.
    Pazienti affetti da linfoma non-Hodgkin (LNH) follicolare CD20+ recidivato o refrattario, di grado 1, 2 o 3a, oppure da un altro LNH indolente CD20+ (macroglobulinemia di Waldenström o linfoma linfoplasmacitico, linfoma della zona marginale) secondo il sistema di classificazione WHO, oppure da un altro linfoma a basso grado di malignità non ulteriormente classificato all’immunoistochimica.
    E.1.1.1Medical condition in easily understood language
    Non-Hodgkin's lymphoma (NHL)
    Linfoma non-Hodgkin (LNH)
    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 the efficacy in term of progression-free survival after randomization (PFSrand) of a subcutaneous (SC) formulation of rituximab in patients who responded to Induction and initial 2 years maintenance therapy (Maintenance I), and were randomized to either prolonged rituximab maintenance until progression (Maintenance II) or observation.
    Valutare l’efficacia, in termini di sopravvivenza libera da progressione (progression-free survival, PFS) dopo la randomizzazione (PFSrand), di una formulazione sottocutanea (sc) di rituximab in pazienti affetti da linfoma non-Hodgkin indolente recidivato o refrattario, che hanno risposto alla terapia di induzione e alla terapia iniziale di mantenimento di 2 anni (Mantenimento I), e che sono stati randomizzati al trattamento di mantenimento con rituximab somministrato continuativamente fino alla progressione (Mantenimento II) oppure all’osservazione.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and safety of SC rituximab during Induction, initial 2-year maintenance (Maintenance I) and randomized treatment period (Maintenance II). Efficacy will be evaluated in terms of Event- Free Survival (EFS), Time to Next Lymphoma Treatment (TNLT), Overall survival (OS), Overall Response Rate (ORR), Partial Response (PR) to Complete Response (CR) conversion rate, and PFS measured from the first Induction dose of rituximab (PFSregist). Safety assessments will include frequency of adverse events (AEs), serious adverse events (SAEs), and infusion/injection-related reactions (IRRs) and immunoglobulin (Ig) quantification.
    Valutare efficacia e sicurezza di rituximab sc durante il periodo di induzione, il periodo iniziale di mantenimento di 2 anni (Mantenimento I) e il periodo di trattamento randomizzato (Mantenimento II). L’efficacia sarà valutata in termini di sopravvivenza libera da eventi , tempo al successivo trattamento anti-linfoma, soppravvivenza globale, tasso di risposta globale, tasso di conversione dalla risposta parziale alla risposta completa e PFS misurati dalla somministrazione della prima dose di induzione di rituximab.Le valutazioni di sicurezza includeranno la frequenza degli eventi avversi,degli eventi avversi seri e delle reazioni correlate all’infusione/iniezione e la quantificazione delle immunoglobuline (Ig).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOECONOMIC:
    Vers:6.0
    Date:2011/06/29
    Title:Time and Motion Study of Rituximab (MabThera) Subcutaneous and Intravenous Formulations: M-10676
    Objectives:The objectives of this study are to: i. Quantify resource utilization in terms of “active” HCP time and consumables, as well as associated costs, related to MabThera SC injection and MabThera IV infusion in patients with iNHL ii. Estimate average time (and cost) for SC and IV processes on a per patient and per site basis, as well as estimate potential time and cost savings with a switch from IV to SC administration route per site and per country (by pooling data from all sites in a country), and simulate time (and cost) for various levels of site SC uptake.

    FARMACOECONOMIA:
    Vers:6.0
    Data:2011/06/29
    Titolo:Studio di tempi e metodi (Time and Motion) sulle formulazioni di rituximab (MabThera) per somministrazione sottocutanea (SC) ed endovenosa (EV): M-10676
    Obiettivi:Gli obiettivi dello studio sono i seguenti: i. Documentare l`utilizzo di risorse in termini di tempo `attivo` del personale sanitario e di materiali di consumo, cosi' come dei relativi costi, associati alle somministrazioni delle iniezioni SC e alle infusioni EV di MabThera in pazienti affetti da iNHL. ii. Stimare tempi (e costi) medi dei processi SC ed EV per paziente e per centro, stimare il potenziale risparmio di tempo e di costi associato al passaggio dalla somministrazione EV a quella SC per centro e per Paese (accorpando i dati di tutti i centri presenti in un Paese), e simulare tempi (e costi) per diversi livelli di adozione della somministrazione SC presso i singoli centri.

    E.3Principal inclusion criteria
    - Age ≥ 18 years. - Histologically confirmed, CD20+ follicular NHL Grade 1, 2 or 3a, orother CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to the WHO classification system, other not further classified low malignant lymphoma by immunohistochemistry. - Patients must have received and must have relapsed or been refractory to one or more lines of adequate induction therapy prior to enrolment, including at least one line consisting of immunotherapy and/or chemotherapy. • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
    - età ≥18 anni; - diagnosi istologicamente confermata di LNH follicolare CD20+ di grado 1, 2 o 3a, oppure di un altro LNH indolente CD20+ (macroglobulinemia di Waldenström o linfoma linfoplasmacitico, linfoma della zona marginale) secondo il sistema di classificazione WHO, oppure di un altro linfoma a basso grado di malignità non ulteriormente classificato all’immunoistochimica; - i pazienti devono aver ricevuto ed essere ricaduti o risultati refrattari a una o più linee di una terapia di induzione adeguata prima dell’arruolamento, ivi compresa almeno una linea di trattamento costituita dall’immunoterapia e/o dalla chemioterapia; - performance status secondo l’Eastern Cooperative Oncology Group (ECOG) ≤2.
    E.4Principal exclusion criteria
    - Transformation to high-grade lymphoma. - Patients with aggressive lymphoma (e.g. mantle cell lymphoma). - Presence or history of central nervous system (CNS) lymphomatous disease (e.g., CNS lymphoma or lymphomatous meningitis). - Other malignancy within 5 years prior to enrolment, with the following exceptions (as long as curatively treated): carcinoma in situ of the cervix, squamous cell carcinoma of the skin, or basal cell skin cancer. Cervical carcinoma stage 1B or less, breast cancer in situ, or localized prostate cancer stage T1c or less may be considered, provided that the patient was treated with curative intent and has been relapse- and metastasis-free for at least 2 years prior to enrolment. - Inadequate hepatic or renal function prior to the first rituximab induction dose. - Known human immunodeficiency virus (HIV) infection.
    - evoluzione in linfoma di alto grado; - pazienti affetti da linfoma aggressivo (es. linfoma a cellule mantellari); - presenza o storia di malattia linfomatosa del sistema nervoso centrale (SNC) (es. linfoma del SNC o meningite linfomatosa); - storia di un’altra neoplasia maligna nei 5 anni precedenti l’arruolamento, ad eccezione dei tumori elencati di seguito (a condizione che questi tumori siano trattati con intento curativo): carcinoma in situ della cervice, carcinoma cutaneo squamocellulare o carcinoma cutaneo basocellulare. Il carcinoma cervicale di stadio 1B o inferiore, il carcinoma mammario in situ o il carcinoma prostatico localizzato di stadio T1c o inferiore possono essere considerati, purché il paziente sia stato trattato con intento curativo e non abbia avuto recidive e metastasi per almeno 2 anni prima dell’arruolamento; - funzione epatica inadeguata prima dell’inizio della terapia di induzione con rituximab; -infezione nota da virus dell’immunodeficienza umana (HIV);
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of the study is PFSrand. It is defined as the time from day of randomization to maintenance phase II to the first documented disease progression or death, whichever occurs first.
    L'end point di efficacia primario è la sopravvivenza libera da malattia dopo la randomizzaizone (Progression-free Survival, PFSrand). La PFSrand sarà misurata dal giorno della randomizzazione fino alla data del primo evento documentato di progressione della malattia o del decesso per tutte le cause, a seconda di quale evento si verifichi per primo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 every 8 weeks [56 ± 7 days] until PD.
    Giorno 1 ogni 8 settiamne (56 +/- 7 giorni) fino a pregressione di malattia.
    E.5.2Secondary end point(s)
    Progression free survival (PFS) measured from the day of first rituximab Induction dose (PFSregist), Event-free survival (EFS), Time to next lymphoma treatment (TNLT), Overall survival (OS), Overall Response Rate (ORR) and PR to CR conversion rate at the end of Induction and end of Maintenance I.
    Progressione libera da malattia, misurata dal giorno della prima dose di induzione di rituximab (PFSregist); sopravvivenza libera da eventi, misurata dal giorno della prima dose di induzione di rituximab;tempo al successivo trattamento anti-linfoma; sopravvivenza globale; tasso di risposta globale; tasso di conversione da PR a CR alla fine del periodo di induzione e alla fine del periodo di mantenimento I.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time Frame: Week 24 (cycle 8)
    Time Frame: settima 24 (ciclo 8)
    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 No
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life (QOL)
    Qualità della vita
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    MabThera ev
    MabThera iv
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Albania
    Argentina
    Bosnia and Herzegovina
    Brazil
    Canada
    Colombia
    Ecuador
    Egypt
    India
    Russian Federation
    Switzerland
    Turkey
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date of the final analysis of the
    primary endpoint.
    La fine dello studio è definita come la data dell'analisi finale dell'endpoint primario.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 470
    F.4.2.2In the whole clinical trial 700
    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)
    Follow-up of patients during Maintenance II will occur according to the Schedule of Assessments and will include safety, disease progression, new lymphoma treatments and survival; refer to Section 5.1.3.3 of the protocol for details. Disease progression will be evaluated by the Investigator according to Cheson response criteria for indolent lymphoma every 6 months. Patients with PD will come off study treatment and be followed for survival.
    Follow-up dei pazienti durante il mantenimento II secondo lo Schema delle Valutazioni del protocollo e includerà la sicurezza, la progressione della malattia (PD), nuovi trattamenti per il linfoma e la sopravvivenza. Si rimanda alla sezione 5.1.3.3 del protocollo per maggiori dettagli. La PD sarà valutata medico secondo i criteri di risposta Cheson per il linfoma indolenete ogni 6 mesi. Pazienti con PD dovrannno interrompere il trattamento e saranno seguiti per la sopravvivenza.
    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 Decision2011-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-20
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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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