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    Summary
    EudraCT Number:2013-000450-22
    Sponsor's Protocol Code Number:SENIOR
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-000450-22
    A.3Full title of the trial
    Sub-cutaneous Rituximab-miniCHOP versus Sub-cutaneous Rituximab-miniCHOP + lenalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for patients of 80 years old or more. A multicentric phase III study of the LYSA.
    Rituximab sous-cutané + miniCHOP versus rituximab sous-cutané + miniCHOP + lénalidomide (R2-miniCHOP) chez des patients de 80 ans ou plus présentant un lymphome diffus à grandes cellules B. Etude de phase III, multicentrique du LYSA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy of lenalidomide in combination with chemotherapy subcutaneous rituximab + miniCHOP for the treatment of B-cell lymphoma for patients of 80 years old or more.
    Etude évaluant l'efficacité du lénalidomide en association avec la chimiothérapie rituximab sous-cutané + miniCHOP pour le traitement du lymphome à cellules B chez des patients de 80 ans ou plus.
    A.3.2Name or abbreviated title of the trial where available
    SENIOR
    SENIOR
    A.4.1Sponsor's protocol code numberSENIOR
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    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 supportF.Hoffmann-la Roche Ltd.
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportCELGENE International Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointFabienne MORAND
    B.5.3 Address:
    B.5.3.1Street AddressLYSARC - Centre Hospitalier Lyon-Sud Secteur Sainte Eugénie - Pavillon 6D
    B.5.3.2Town/ cityPIERRE-BÉNITE Cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)472 66 38 53
    B.5.5Fax number33(0)426 07 40 55
    B.5.6E-mailfabienne.morand@lysarc.org
    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 SC
    D.3.2Product code RO 45-2294
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 typeCombination product that contains recombinant human hyaluronidase.
    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 AuthorisationEuropean Union
    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 IV
    D.3.2Product code RO 45-2294
    D.3.4Pharmaceutical form Solution for injection/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 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 No
    D.IMP: 3
    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 Revlimid 5mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 4
    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 Revlimid 10mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification), in patients aged ≥80 years and not previously treated.
    Lymphome diffus à grandes cellules B CD20 + histologiquement prouvé (classification OMS), chez des patients âgés de 80 ans ou plus, et non préalablement traités.
    E.1.1.1Medical condition in easily understood language
    B lymphoma in patients of 80 years old or more, not previously treated.
    Lymphome B chez des patients de 80 ans ou plus non préalablement traités.
    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 20.0
    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
    Primary objective of the study is to compare the efficacy of R2-miniCHOP and R-miniCHOP in patients ≥ 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OS)
    L’objectif principal de l'étude est de comparer l'efficacité du lénalidomide en association avec une chimiothérapie associant rituximab sous-cutané + miniCHOP (R2-miniCHOP) versus rituximab sous-cutané + miniCHOP (R-miniCHOP), mesurée par la survie globale (OS), chez des patients de 80 ans ou plus présentant un lymphome diffus à grandes cellules B CD20+ (DLBCL).
    E.2.2Secondary objectives of the trial
    Secondary objectives are :
    - To evaluate the efficacy and the safety of R2-miniCHOP as measured by the PFS (Progression Free Survival), EFS (Event Free Survival), the DoR (duration of response), the DFS (disease free survival), response rate at the end of the treatment, the additional toxicities
    - To evaluate the simplified scale prognostic impact (IADL, MNA, G8, CIRS-G)
    - To assess the quality of life before and after treatment
    Les objectifs secondaires sont d'évaluer :
    - l'efficacité et la tolérance de l’association R2-miniCHOP mesurées par la PFS (survie sans progression), l’EFS (survie sans événement), la DoR (durée de réponse), la DFS (survie sans réapparition de la maladie), le taux de réponse à la fin du traitement, les toxicités additionnelles observées
    - l’impact pronostique d’échelles d’évaluation simples (IADL, MNA, G8, CIRS-G)
    - la qualité de vie avant et après traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all aaIPI.
    May also be included:
    - De Novo transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell Infiltration in bone marrow or lymph node
    - Or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
    - Or CD20+ Follicular lymphoma grade 3B
    - Or CD20+ Aggressive B-cell lymphoma unclassifiable
    • With a CD10 immunostaining performed by the participating center pathologist

    • Aged ≥ 80 years old

    • Ann Arbor stage II, III or IV

    • Patient previously untreated for DLBCL

    • ECOG performance status ≤ 2

    • With a minimum life expectancy of 3 months

    • Negative HIV, HBV and HCV serologies test within 4 weeks before
    inclusion (except after hepatitis B vaccination or for patients who are
    HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral
    DNA negative)

    • Patient able to give his consent and having signed a written Informed consent

    • Patient affiliated to social security system, if applicable

    • Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following study drug discontinuation, even if they have undergone a successful vasectomy
    • All patients must agree to fulfill the global Lenalidomide Pregnancy Prevention Risk Management Plan as applicable according to the randomization arm (experimental arm)
    • Lymphome B diffus à grandes cellules CD20+ (DLBCL) confirmé histologiquement (WHO Classification 2008) incluant tous les sous-types cliniques (primaires du médiastin, intravasculaires, etc…), avec tous les IPI ajustés à l’âge.
    Peuvent aussi être inclus :
    - Les transformations De Novo de lymphomes indolents (folliculaire, autre…) et les DLBCL associés à une infiltration à petites cellules dans la moelle osseuse ou les ganglions lymphatiques
    - Ou formes frontières CD20+ de lymphome B entre lymphome diffus à grandes cellules B et Burkitt, ou entre lymphome diffus à grandes cellules B et lymphome de Hodgkin classique
    - Ou lymphome folliculaire 3B, CD20+
    - Ou lymphome B CD20+ agressif non classable
    • Résultat de l’immunomarquage CD10 disponible, réalisé par le pathologiste du centre participant
    • Âge ≥ 80 ans
    • Stade Ann Arbor II, III ou IV
    • Patient non préalablement traité pour un lymphome B diffus à grandes cellules
    • Indice de performance ECOG ≤ 2
    • Espérance de vie d’au moins 3 mois
    • Sérologies VIH, hépatite B (négativité anti-HBc) et hépatite C
    négatives dans les 4 semaines avant l'inclusion (sauf après vaccination)négatives dans les 4 semaines avant l’inclusion (sauf après vaccination)
    • Patient en mesure de donner son consentement et ayant signé un formulaire de consentement éclairé
    • Patient affilié à un régime de sécurité sociale, si applicable
    • Les hommes (y compris ceux ayant subi une vasectomie) doivent accepter de pratiquer l’abstinence totale ou d’utiliser un préservatif pendant les rapports sexuels avec une femme enceinte ou une femme susceptible de devenir enceinte, pendant leur participation à l’étude, pendant les interruptions de dose du médicament de l’étude et pendant les 3 mois suivant l’arrêt du médicament de l’étude même s’ils ont subi une vasectomie réussie
    • Tous les patients doivent accepter de remplir le plan de prévention global de gestion des risques de la grossesse du lénalidomide selon le bras de randomisation (bras expérimental)
    E.4Principal exclusion criteria
    • Any other histological type of lymphoma, Burkitt included
    • Any history of treated or non-treated small-B cell lymphoma
    • Central nervous system or meningeal involvement by lymphoma
    • Contra-indication to any drug contained in the chemotherapy regimens ; for anthracycline use, ejection fraction should be > 50%
    • Any serious active disease (according to the investigator’s decision)
    • History of deep venous thrombosis or arterial thromboembolism events within the past 12 months before inclusion
    • Poor renal function (creatinine clearance < 40 ml/min, according to MDRD formula)
    • Poor hepatic function (total bilirubin level >30 µmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma
    • Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration
    • Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
    Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score ≤7, and a prostate specific antigen (PSA) ≤10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e., prostatectomy or radiotherapy) 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy
    • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
    • Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
    • Prior use of lenalidomide
    • Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide
    • Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide
    • Subjects with ≥ Grade 2 neuropathy
    • Adult patient under tutelage
    • Female of childbearing potential are excluded. (Note: Females are defined as not of childbearing potential if there is documentation of “natural menopause for at least 24 consecutive months, a hysterectomy or bilateral oophorectomy”)
    • Tout autre type histologique de lymphome, y compris le lymphome de Burkitt
    • Tout antécédent de lymphome à petites cellules B traité ou non traité
    • Envahissement méningé ou du système nerveux central par le lymphome
    • Contre-indication à l’un des produits de chimiothérapie ; pour l’utilisation des anthracyclines, la fraction d’éjection (LVEF) devrait être supérieur à 50%
    • Pathologie sérieuse évolutive (sur décision de l’investigateur)
    • Antécédents de thrombose veineuse profonde ou d’évènements thromboemboliques artériels dans les 12 mois précédant l’inclusion
    • Altération de la fonction rénale (clairance de la créatinine < 40 mL/min, selon la formule MDRD)
    • Altération de la fonction hépatique (bilirubine totale >30 µmol/l, transaminases >2,5 valeurs normales) sauf si ces anomalies sont liées au lymphome
    • Réserves médullaires faibles définies par des polynucléaires neutrophiles sanguins < 1,5 G/L ou des plaquettes < 100 G/l, sauf si lié à une infiltration de la moelle
    • Tout antécédent de cancer au cours des 5 dernières années, à l’exception des tumeurs de la peau non mélanomateuse et du carcinome cervical de stade 0 (in situ)
    Les patients préalablement diagnostiqués avec un cancer de la prostate sont éligibles si (1) leur maladie était T1-T2a, N0, M0, avec un score de Gleason ≤7, et antigène spécifique de la prostate (PSA) ≤10 ng/mL avant le début du traitement, (2) ils ont eu un traitement curatif (i.e. prostatectomie ou radiothérapie) 2 ans avant le Jour 1 du Cycle 1, et (3) un minimum de 2 ans après le traitement sans signe de récidive clinique du cancer de la prostate, et leur PSA doit être indétectable s’ils ont subi une prostatectomie ou <1 ng/mL s’ils n’ont pas eu de prostatectomie.
    • Le traitement avec un médicament expérimental dans les 30 jours avant le premier cycle de chimiothérapie prévu et lors de l'étude
    • Traitement par un anticorps monoclonal anti-CD20 ou alemtuzumab dans les 3 mois précédant le début du traitement de l’essai
    • Traitement antérieur par du lénalidomide.
    • Antécédent de réaction allergique ou d’hypersensibilité de Grade ≥ 3 au thalidomide
    • Antécédent d’éruption cutanée de Grade ≥ 3 ou tout autre éruption cutanée desquamante (cloques) lors de la prise de thalidomide
    • Neuropathie ≥ Grade 2
    • Patient adulte sous tutelle
    • Femme en âge de procréer (Note: Les femmes sont définies comme n’étant pas en âge de procréer en cas de "ménopause naturelle pendant au moins 24 mois consécutifs, hystérectomie ou ovariectomie bilatérale" documentée)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the overall survival (OS).
    Le critère principal est la survie globale (OS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival will be measured from the date of randomization to the date of death from any cause. Alive patients will be censored at their last contact.
    La survie globale est mesurée à partir de la date de randomisation jusqu'à la date de décès toute cause. Les pateitns en vie seront censurés de l'analyse à la date de leur dernier contact.
    E.5.2Secondary end point(s)
    - Progression-Free Survival (PFS)
    - Event-Free Survival (EFS)
    - Duration of Response (DoR)
    - Disease-Free Survival (DFS)
    - Overall Survival (OS) according to GCB/non-GCB phenotype
    - Response Rate at the end of the treatment (after end of the 6th cycle of treatment or at premature withdrawal) will be assessed using disease response evaluation at end of treatment, according to Cheson 1999
    - Simplified geriatric scale, based on four geriatric tools that will be performed before any chemotherapy administration (IADL, MNA, G8, and CIRS-G scales) will be analyzed in order to have a picture of the population at baseline, to evaluate the prognosis impact in OS and PFS of each scale and to evaluate the toxicity predictive power of these scales
    - Health related Quality of Life (HRQoL) will be assessed by the QLQ-C30 and the QLQ-ELD14 at randomization and at end of treatment. The improvement or not of the QoL will therefore be assessed
    - PFS (survie sans progression)
    - EFS (survie sans événement)
    - DoR (durée de réponse)
    - DFS (survie sans réapparition de la maladie),
    - OS (survie globale) selon le phénotype GCB/non-GCB
    - Taux de réponse à la fin du traitement (après la fin du 6e cycle de traitement ou lors d'une sortie d'étude prématurée) évalué à l'aide de l'évaluation de la réponse à la fin du traitement, selon Cheson 1999
    - Échelle gériatrique simplifiée, basée sur quatre outils gériatriques qui seront effectués avant toute administration de la chimiothérapie (échelles IADL, MNA, du G8, et CIRS-G) sera analysée afin d'avoir une image de la population avant traitement (baseline), pour évaluer l'impact pronostic de chaque échelle sur l'OS et la PFS et pour évaluer le pouvoir prédictif de ces échelles sur la toxicité
    - Echelle de qualité de vie liée à la santé évaluée par le QLQ-C30 et QLQ-ELD14 lors de la randomisation et à la fin du traitement. L'amélioration ou non de la qualité de vie seront donc évalués (avant et après traitement)
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS : time from randomization to the first observation of documented disease progression/relapse or death due to any cause.
    EFS : measured from the date of randomization to the date of first documented disease progression/relapse (Cheson 1999), initiation of new anti-lymphoma therapy or death from any cause.
    DoR : measured from the time of attainment of CR/CRu or PR to the date of first documented disease progression/relapse or death from any cause.
    DFS : measured from the date of attainment of CR/CRu (at the end of treatment or at withdrawal evaluation) to the date of first observation of documented disease progression or death due to any cause.
    Four geriatric tools : before any chemotherapy administration.
    HRQoL assessed at randomization and at end of treatment.
    PFS: temps entre randomisation et première observation de la progression de la maladie documentée/rechute ou décès toute cause
    EFS: de la date de randomisation jusqu'à la date de première progression de la maladie/rechute documentée (Cheson 1999), de l'initiation d'un nouveau traitement anti-lymphome ou décès toute cause
    DoR: à partir de l'atteinte des CR/CRu ou PR à la date de la première progression de la maladie/rechute documentée ou décès toute cause
    DFS: mesurée à partir de la date d'atteinte des CR/Cru (fin du traitement ou évaluation de sortie d'étude) à la date de la première observation de progression de la maladie documentée ou décès toute cause
    Quatre outils gériatriques: avant toute administration de la chimiothérapie
    Qualité de vie à randomisation et en fin detraitement
    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) 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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 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 last patient's last visit and will occur approximately 4.5 years at the latest after the first patient is randomized.
    La date de fin d'étude est définie par la dernière visite du dernier patient et sera approximativement 4,5 ans au plus tard après le premier patient randomisé dans l’étude.
    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 months6
    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 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: 250
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    None except if patient withdraws from the study, then he will receive a salvage therapy.
    Non sauf si le patient sort de l'étude, il reçoit alors un traitement de secours.
    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 Decision2014-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-22
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