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    Summary
    EudraCT Number:2012-000669-19
    Sponsor's Protocol Code Number:MO28107
    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:2012-08-31
    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 number2012-000669-19
    A.3Full title of the trial
    A COMPARATIVE, RANDOMIZED, PARALLEL-GROUP, MULTI-CENTRE, PHASE
    IIIB STUDY TO INVESTIGATE THE EFFICACY OF SUBCUTANEOUS (SC)
    RITUXIMAB VERSUS INTRAVENOUS (IV) RITUXIMAB BOTH IN
    COMBINATION WITH CHOP (R-CHOP) IN PREVIOUSLY UNTREATED
    PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA
    (DLBCL).
    Studio comparativo, randomizzato, a gruppi paralleli, multicentrico, di fase IIIb per la valutazione dell'efficacia di rituximab sottocutaneo (SC) rispetto a rituximab endovenoso (EV) entrambi in associazione con CHOP (R-CHOP) in pazienti non trattati in precedenza, affetti da linfoma diffuso a grandi cellule B (LDGCB) CD20 positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing efficacy of subcutaneous (SC) rituximab and
    intravenous (IV) rituximab both in combination with CHOP (R-CHOP) in
    previously untreated patients with CD20 positive diffuse large B-cell
    lymphoma (DLBCL).
    Studio che confronta l'efficacia di rituxumab sottocutaneo(SC) e di rituxumab endovenoso(EV), entrambi in combinazione con CHOP(R-CHOP) in pazienti con linfoma diffuso a grandi cellule B (LDGCB), non precedentemente trattati.
    A.4.1Sponsor's protocol code numberMO28107
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-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 pointHead of Clin. Ops Italy
    B.5.3 Address:
    B.5.3.1Street AddressV.le G.B. Stucchi 110
    B.5.3.2Town/ cityMonza (MB)
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 039 247 5070
    B.5.5Fax number+39 039 247 5085
    B.5.6E-mailITALY.INFO_CTA@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 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.3.9.2Current sponsor codeRO0452294
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 RoleComparator
    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.3.9.2Current sponsor codeRO0452294
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Adult patients aged 18-80 years with previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL)
    pazienti adulti di età compresa tra 18 e 80 anni affetti da linfoma diffuso a grandi cellule B (DLBCL) CD-20 positivo non trattato in precedenza
    E.1.1.1Medical condition in easily understood language
    previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL)
    pazienti affetti da linfoma diffuso a grandi cellule B (DLBCL) CD-20 positivo non trattato in precedenza
    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 15.1
    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 estimate the efficacy in each treatment arm, as measured by complete response (CR) rate 4‒8 weeks after the end of treatment.
    valutare l'efficacia in ciascun braccio di trattamento in termini di tasso di risposta completa (CR) 4-8 settimane dopo la fine del trattamento
    E.2.2Secondary objectives of the trial
    • To compare patient satisfaction with rituximab administration (SC versus IV) in patients with DLBCL • To evaluate event-free survival, disease-free survival, progression-free survival and overall survival from randomisation (at least 24 months of follow-up) • To evaluate the safety of rituximab (SC versus IV) in patients with DLBCL
    • Confrontare il grado di soddisfazione dei pazienti con DLBCL nei confronti del trattamento con rituximab SC rispetto a rituximab EV • Valutare la sopravvivenza libera da eventi (EFS), la sopravvivenza libera da malattia (DFS), la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS) dalla randomizzazione (almeno 24 mesi di follow-up) • Valutare la sicurezza di rituximab SC rispetto a rituximab EV in pazienti affetti da DLBCL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 and ≤ 80 years at time of study inclusion • Histologically confirmed, previously untreated CD20-positive DLBCL according to the WHO classification system • Patients with an IPI score of 1-5 or IPI score of 0 with bulky disease, defined as one lesion ≥ 7.5 cm • At least one bi-dimensionally measurable lesion defined as ≥ 1.5 cm in its largest dimension on CT scan • Adequate hematologic function • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
    • Età compresa tra ≥ 18 e ≤ 80 anni al momento dell'inclusione nello studio • Diagnosi istologicamente confermata di DLBCL CD20 positivo non trattato in precedenza , secondo il sistema di classificazione dell'OMS • Pazienti con punteggio IPI di 1-5 o punteggio IPI di 0 con malattia bulky, definita da una lesione ≥ 7,5 cm • Almeno una lesione misurabile bidimensionalmente, definita come ≥ 1,5 cm nella sua dimensione massima sulla TAC o RM • Funzionalità ematologica adeguata • Performance status sulla scala ECOG (Eastern Cooperative Oncology Group) ≤ 2
    E.4Principal exclusion criteria
    • Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma • Presence or history of CNS disease • History of malignancy other than follicular NHL which could affect compliance with protocol or interpretation of results • Recent major surgery (within 4 weeks prior to screening, excluding lymph node biopsy).
    • Linfoma primitivo del sistema nervoso centrale, variante blastica di linfoma mantellare o evidenza istologica di trasformazione in linfoma di Burkitt, DLBCL primitivo del mediastino, linfoma primitivo delle cavità sierose, DLBCL cutaneo primitivo o DLBCL primitivo dei testicoli • Linfoma trasformato o linfoma follicolare IIIB • Anamnesi di altra malignità che potrebbe influenzare la compliance con i protocollo o l'interpretazione dei risultati • Intervento chirurgico maggiore recente (nelle 4 settimane precedenti l'inizio della somministrazione del farmaco in studio), fatta eccezione per quelli a scopo diagnostico
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of CR/CRu(measured from the day of first rituximab induction dose) will be based on the Investigator's assessment, completed according to the International Working Group response criteria (Cheson et al. 1999) at the end of induction treatment.
    L'endpoint primario di tasso di risposta completa (CR/CRu), misurato dal giorno della prima dose di induzione con rituximab, sarà basato sulla valutazione dello sperimentatore, eseguita secondo i criteri di risposta dell'International Working Group (Cheson et al. 1999) alla fine del trattamento di induzione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of response rate will take place when all patients have completed their induction treatment.
    L'analisi primaria del tasso di risposta verrà effettuata quando tutti i pazienti avranno completato il loro trattamento di induzione.
    E.5.2Secondary end point(s)
    Event-free survival, disease-free survival, progression-free survival and overall survival (EFS, DFS, PFS and OS), patient reported outcomes, administration times and a summary of safety data.
    Sopravvivenza libera da eventi (EFS), sopravvivenza libera da malattia (DFS), sopravvivenza libera da progressione (PFS) e sopravvivenza globale (OS), esiti riportati dal paziente, tempi di somministrazione e sommario dei dati di sicurezza.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A preliminary analysis will be performed when all patients have completed their induction treatment. The final analysis of secondary efficacy endpoints (EFS, DFS, PFS and OS) will be provided when the last patient has completed at least 24 months of follow-up after the end of induction treatment, or when one of the following has been documented for all randomized patients: disease recurrence, withdrawal from the study, loss to follow up or death, whichever occurs first.
    Un'analisi preliminare verrà effettuata quando tutti i pazienti avranno completato il loro trattamento di induzione. L'analisi finale degli obiettivi secondari di efficacia (EFS, DFS, PFS and OS) verrà effettuata quando l'ultimo paziente avrà completato almeno 24 mesi di follow-up dopo la fine del trattamento di induzione, o quando verrà documentato per tutti i pazienti randomizzati uno dei seguenti eventi, qualsiasi accada prima: ricaduta di malattia, uscita dallo studio, perdita al follow-up o decesso.
    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 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 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) 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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Algeria
    Argentina
    Brazil
    Canada
    Colombia
    India
    Israel
    Peru
    Russian Federation
    Saudi Arabia
    South Africa
    Thailand
    Turkey
    Ukraine
    Venezuela, Bolivarian Republic of
    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
    End of study is defined as the last patient last visit in the follow-up
    period. The study will end when all patients have been followed for at
    least 24 months after their last dose of study treatment, or earlier, if
    one of the following is documented for all treated patients: disease
    recurrence, withdrawal from the study, loss to follow up or death.
    Ultima visita ultimo pt nel f-up.Lo studio finirà quando tutti i pts saranno stati seguiti x 24 mesi dopo ultima dose di farmaco,o prima,se sarà documentata in tutti i pt trattati ricaduta di malattia o uscita dallo studio o perdita al f-up o morte.
    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
    E.8.9.2In all countries concerned by the trial years4
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    For men (unless vasectomized): agreement to use a barrier method of
    contraception
    Per i pt maschi(a meno di aver fatto vasectomia): devono usare un metodo contraccettivo di barriera
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 302
    F.4.2.2In the whole clinical trial 600
    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)
    There are no defined plans for treatment of patients after the study termination.
    Non sono stati definiti programmi per il trattamento dei pazienti al termine dello studio.
    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 Decision2012-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-16
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