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    Summary
    EudraCT Number:2010-023407-95
    Sponsor's Protocol Code Number:MO25455
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-023407-95
    A.3Full title of the trial
    A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin's lymphoma who completed and responded to a 6-month rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
    Estudio randomizado para comparar el tratamiento de mantenimiento con rituximab subcutáneo administrado hasta la progresión de la enfermedad, con sólo observación, en pacientes con linfoma no Hodgkin indolente, recurrente o refractario, que han completado y respondido a tratamiento de inducción con inmunoquimioterapia basada en rituximab y a tratamiento de mantenimiento inicial de 2 años con rituximab administrado por vía subcutánea.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare subcutaneous MabThera (rituximab) maintenance therapy continued until progression with observation in relapsed/refractory NHL patients who have completed and responded to MabThera containing induction/maintenance therapy.
    Estudio para comparar el tratamiento de mantenimiento con MabThera (rituximab) subcutáneo administrado hasta la progresión de la enfermedad, con sólo observación, en pacientes con linfoma no Hodgkin recurrente / refractario, que han completado y respondido a tratamiento de inducción/mantenimiento de Mabthera.
    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 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 organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@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/rHuPH20 SC
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRO0452294
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 typeAnticuerpo monoclonal humanizado recombinante
    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 500 mg concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.9.3Other descriptive nameRITUXIMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 typeAnticuerpo monoclonal humanizado recombinante
    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.
    Pacientes con linfoma no Hodgkin (LNH) folicular CD20+, recurrente o refractario, de grado 1, 2 o 3a, u otro tipo de LNH indolente CD20+ (macroglobulinemia de Waldenström o linfoma linfoplasmacítico, linfoma de la zona marginal) de acuerdo con el sistema de clasificación de la OMS, u otros linfomas malignos de grado bajo no clasificados de forma específica en inmunohistoquímica.
    E.1.1.1Medical condition in easily understood language
    non-Hodgkin's lymphoma (NHL)
    Linfoma no 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10067070
    E.1.2Term Follicular B-cell non-Hodgkin's 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 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.
    Evaluar la eficacia con respecto a la supervivencia libre de progresión tras la randomización (SLPrand) de una formulación subcutánea (SC) de rituximab en pacientes con linfoma no Hodgkin indolente, recurrente o refractario, que han respondido a tratamiento de inducción y a tratamiento de mantenimiento inicial de 2 años (mantenimiento I) y han sido randomizados para recibir tratamiento de mantenimiento continuado con rituximab hasta la progresión de la enfermedad (mantenimiento II) o ser sometidos a observación.
    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.
    Evaluar la eficacia y la seguridad de rituximab SC durante los períodos de tratamiento de inducción, de tratamiento de mantenimiento inicial de 2 años (mantenimiento I) y de tratamiento randomizado (mantenimiento II). La eficacia se evaluará basándose en la supervivencia libre de acontecimientos (SLA), el tiempo hasta el siguiente tratamiento para el linfoma (TSTL), la supervivencia global (SG), el índice de respuesta global (IRG), el índice de conversión de respuesta parcial (RP) a respuesta completa (RC) y la SLP determinada desde la administración de la primera dosis de rituximab en el período de tratamiento de inducción (SLPregist). Las evaluaciones de seguridad incluirán la incidencia de acontecimientos adversos (AA), acontecimientos adversos graves (AAG) y reacciones relacionadas con la infusión/inyección (RRI) y la cuantificación de inmunoglobulinas (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
    Select sites will also participate in a Time in Motion pharmacoecenomic sub-study that will assess Medical Care Utilization (MCU) parameters. Details of the sub-study will be described in a separate protocol.
    Estudio Time and Motion de las formulaciones subcutánea (SC) e intravenosa (IV) de rituximab (MabThera) para el tratamiento del linfoma no Hodgkin indolente (LNHi).
    Versión 6.0 del 05 julio 2011 (inglés del 29 junio 2011).
    Para evaluar los parámetros de utilización de recursos médicos (URM), que permitirá recoger datos sobre la duración de la infusión y el uso de recursos y estará basado en un protocolo que se llevará a cabo solo en determinados centros. Detalles en protocolo independiente.
    E.3Principal inclusion criteria
    - Age ? 18 years.
    - Histologically confirmed, CD20+ follicular 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, 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 < or = 2.
    - Edad > o igual a 18 años.
    - LNH folicular CD20+ de grado 1, 2 o 3a, confirmado histológicamente, u otros tipos de LNH indolente CD20+ (macroglobulinemia de Waldenström o linfoma linfoplasmacítico, linfoma de la zona marginal), de acuerdo con el sistema de clasificación de la OMS, u otros linfomas malignos de grado bajo no clasificados de forma específica en inmunohistoquímica.
    - Los pacientes deben haber manifestado recidiva o haber sido refractarios a una o más líneas de tratamiento de inducción previo adecuado, incluyendo al menos una línea de inmunoterapia y/o quimioterapia, antes de su inclusión en el estudio.
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) < o igual a 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.
    - Transformación a linfoma de grado alto.
    - Pacientes con linfoma agresivo (p. ej. linfoma de células del manto).
    - Presencia o antecedentes a enfermedad linfomatosa del sistema nervioso central (SNC) (p. ej. linfoma del SNC o meningitis linfomatosa).
    - Otras neoplasias malignas en los 5 años previos a la inclusión en el estudio, con las siguientes excepciones (siempre que se hayan tratado con intención curativa): carcinoma in situ de cervix, carcinoma de piel escamocelular o basocelular. Se puede considerar la inclusión de pacientes con carcinoma de cervix en estadio 1B o inferior, cáncer de mama in situ o cáncer de próstata localizado en estadio T1c o inferior, siempre que el paciente haya sido tratado con intención curativa y haya estado libre de recidiva y metástasis, como mínimo, en los 2 años previos a la inclusión en el estudio.
    - Función hepática o renal inadecuada antes de administrar la primera dosis de rituximab en el tratamiento de inducción.
    - Infección confirmada por el virus de inmunodeficiencia humana (VIH).
    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.
    Variable principal de eficacia del estudio es SLPrand: se determinará desde el día de la randomización hasta la fecha en que se documenta por primera vez la progresión de la enfermedad o la muerte, lo que ocurra primero.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 every 8 weeks [56 ± 7 days] until PD
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time Frame: Week 24 (cycle 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 Yes
    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)
    Calidad de vida
    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 i.v
    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
    Austria
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Colombia
    Ecuador
    Egypt
    France
    Germany
    Greece
    Hungary
    India
    Italy
    Norway
    Russian Federation
    Slovakia
    Slovenia
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    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 terminación del estudio se define como la fecha del análisis final de la variable principal.
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 (Table 6) and will include safety, disease progression, new lymphoma treatments and survival; refer to Section
    5.1.3.3 for details. Disease progression will be evaluated by the Investigator according to Cheson response criteria for indolent lymphoma (see Appendix 1) every 6 months. Patients with PD will come off study treatment and be followed for survival.
    El seguimiento de pacientes durante el tratamiento de mantenimiento II se realizará de acuerdo al esquema de evaluaciones (Tabla 6) e incluirá evaluaciones de seguridad, progresión de la enfermedad,
    tratamientos nuevos para linfoma y supervivencia (ver Sección 5.1.3.3). La progresión de la enfermedad será evaluada por el investigador de acuerdo con los criterios de respuesta de Cheson en linfoma indolente (ver Anexo 1) cada 6 meses. Los pacientes que manifiesten PE dejarán de...
    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 Decision2011-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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