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    Summary
    EudraCT Number:2012-002542-20
    Sponsor's Protocol Code Number:MCL-R2Elderly
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-05-05
    Trial 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 number2012-002542-20
    A.3Full title of the trial
    Efficacy of alternating immunochemotherapy consisting of R-CHOP + R-HAD versus R-CHOP alone, followed by maintenance therapy consisting of additional lenalidomide with rituximab versus rituximab alone for older patients with mantle cell lymphoma
    Efficacité et tolérance d'un traitement d'immunochimiothérapie d'induction de type R-CHOP + R-HAD versus R-CHOP seul, suivi d'un traitement de maintenance par lenalidomide + rituximab versus placebo + rituximab chez des patients âgés atteints d'un lymphome du manteau
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of therapy consisting of R-CHOP + R-HAD versus R-CHOP alone, followed by maintenance therapy consisting of lenalidomide + rituximab versus rituximab alone for older patients with mantle cell lymphoma
    Efficacité et tolérance d'un traitement R-CHOP + R-HAD versus R-CHOP seul, suivi d'un traitement de maintenance par lenalidomide + rituximab versus placebo + rituximab chez des patients âgés atteints d'un lymphome du manteau
    A.4.1Sponsor's protocol code numberMCL-R2Elderly
    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 supportCelgene
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportHoffmann La Roche
    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 pointChristine STEPHAN
    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 number33472 66 93 33
    B.5.5Fax number33426 07 40 55
    B.5.6E-mailchristine.stephan@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 Yes
    D.2.1.1.1Trade name Revlimid 15 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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
    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 number15
    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: 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 Revlimid 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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
    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.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 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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
    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 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/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 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 Yes
    D.3.11.13.1Other medicinal product typeContains recombinant human hyaluronidase
    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
    Mantle Cell Lymphoma
    Lymphome du manteau
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    Lymphome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061275
    E.1.2Term Mantle 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
    The primary objective of the trial is to evaluate whether the addition of lenalidomide to standard rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after response to induction chemotherapy in older patients with mantle cell lymphoma not suitable for autologous stem cell transplantation
    L'objectif principal de l'étude est d'évaluer si l'ajout de lenalidomide à un traitement de maintenance par rituximab améliore la survie sans progression comparé à la maintenance standart par rituximab chez des sujets âgés présentant un lymphome du manteau ayant répondu à un traitement d'induction et inéligible pour une autogreffe
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives are:
    • to compare efficacy and safety of the maintenance regimens in terms of secondary endpoints
    • to evaluate whether the introduction of cytarabine into induction improves clinical outcome compared to standard R-CHOP in older patients with mantle cell lymphoma not suitable for autologous stem cell transplantation
    Les objectifs secondaires d'efficacité sont de :
    • comparer l'efficacité et la tolérance des régimes de maintenance selon les critères secondaires
    • évaluer si l'ajout de cytarabine dans le traitement d'induction améliore la réponse clinique comparé au traitement standard R-CHOP chez les sujets âgés ayant un lymphome du manteau non éligibles pour une autogreffe
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • signed informed consent form
    • Biopsy-proven mantle cell lymphoma according to WHO classification, including evidence of cyclin D1 overexpression or the translocation t(11;14)(q13;q32).
    • ≥ 60 years of age and ineligible for autologous transplant
    • Ann Arbor stage II-IV
    • previously untreated
    • ECOG performance status ≤ 2
    • Male subjects must:
    - agree to use a condom during sexual contact with a woman of childbearing potential, even if they have had a vasectomy, throughout lenalidomide/placebo therapy
    - agree to not donate semen during lenalidomide therapy.
    • All subjects must:
    - have an understanding that the lenalidomide could have a potential teratogenic risk.
    - agree to abstain from donating blood while taking lenalidomide therapy
    - agree not to share study medication with another person.
    - be counseled about pregnancy precautions and risks of fetal exposure.

    • Additional criteria for randomization in maintenance phase :
    - CR, CRu or PR after induction treatment, determined as per Cheson 1999 criteria by investigator
    - During the run-in period of 6 months starting from the date of the first patient randomized in the trial: in case of direct randomization into maintenance phase, patient must have been treated in first line by 6-8 cycles of R-CHOP.
    • signature d'un consentement éclairé
    • lymphome du manteau histologique prouvé selon la classification OMS, incluant la présence d'une surexpression de la cycline D1 ou la translocation t(11;14)(q13;q32).
    • ≥ 60 ans et inéligible pour une autogreffe
    • Stade Ann Arbor II-IV
    • Non antérieurement traité
    • Performance status ECOG ≤ 2
    • Les hommes doivent:
    - accepter d'utiliser un préservatif lors de rapports sexuels avec une femme en age de procréer, même s'il a subit une vasectomie et ce pendant tout le traitement par lenalidomide
    - accepter de ne pas faire de don de sperme pendant tout le traitement par lenalidomide
    • Tous les sujets doivent:
    - avoir compris que la prise de lenalidomide peut présenter un risque tératogène
    - accepter de ne pas faire de don de sang pendant tout le traitement par lenalidomide
    - accepter de ne pas partager le traitement à l'essai avec d'autre
    personnes
    - être conseillés sur la prévention des grossesses et les risques d'exposition foetale
    • Critères additionnels pour la randomisation en maintenance :
    - en RC, RCi ou RP après le traitement d'induction déterminé par l'investigateur selon les critères de Cheson, 1999
    - pendant une période de 6 mois débutant à la date de randomisation du premier patient dans l'étude : pour pouvoir être randomisé directement en maintenance, le patient doit avoir reçu un traitement d'induction de 6 à 8 R-CHOP
    E.4Principal exclusion criteria
    • Female of child-bearing potential (without natural menopause for at least 24 consecutive months, a hysterectomy or bilateral oophorectomy)
    • Any of the following laboratory abnormalities, if not related to lymphoma:
    - Absolute neutrophils count (ANC) <1,000 /mm3 (1.0 x 109/L) if not result of a BM infiltration.
    - Platelet count < 75,000/mm3 (75 x 109/L) if not result of a BM infiltration.
    - Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit of normal.
    - Serum total bilirubin > 1.5 UNL (except if due to Gilbert’s syndrome)
    • Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) < 30 mL /min.
    • Central nervous system involvement by lymphoma
    • Contraindication for medicamentous DVT prophylaxis
    • Prior history of malignancies other than MCL unless the subject has been free of the disease for ≥ 5 years (Exceptions: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or of the breast, Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).
    • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient to receive the study medication as planned.
    • Poor cardiac function (LVEF < 50%) on echecardiography
    • Seropositivity for human immunodeficiency virus (HIV, mandatory test)
    Seropositivity for hepatitis C virus (HCV, mandatory test),
    Active viral infection with hepatitis B virus (HBV, mandatory test):
    - HBsAg positive
    - HBsAg negative, anti-HBs positive and anti-HBc positive
    • Uncontrolled illness including, but not limited to:
    - Active infection requiring parenteral antibiotics
    - Uncontrolled diabetes mellitus
    - Chronic symptomatic congestive heart failure (Class NYHA III or IV).
    - Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
    - Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.
    • Prior ≥ Grade 3 allergic hypersensitivity to thalidomide.
    • Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
    • Subjects with ≥ Grade 2 neuropathy.
    • Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
    • Prior use of lenalidomide.
    • Participation in another clinical trial within three weeks before randomization in this study

    Additional exclusion criteria for randomization in maintenance phase:
    - SD or PD after induction treatment determined as per Cheson 1999 criteria assessed by investigator.
    - Patients who had not received at least 6 cycles of R-CHOP21 or 2 cycles of R-CHOP21 / 2 cycles of R-HAD28 (alternating)
    - Patients with serious underlying medical conditions, which could impair the ability to receive maintenance treatment
    - Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 30 mL /min at screening for maintenance.
    - ANC < 1,000 cells/mm³ (1.0 X 109/L) at screening for maintenance;
    - Platelet count < 50,000 cells/mm³ (50 X 109/L) at screening for maintenance.
    • Femme en âge de procréer
    • Toute anomalie biologique suivante sauf si liée au lymphome:
    - Neutrophiles <1,000 /mm3 (1.0 x 109/L) si non relié à un envahissement médullaire
    - Plaquettes < 75,000/mm3 (75 x 109/L) si non relié à un envahissement médullaire
    - Aspartate transaminase sérique (AST/SGOT) ou alanine transaminase (ALT/SGPT) >3.0 fois la normale supérieure
    - Bilirubine sérique totale > 1.5 fois la normale supérieure (sauf si dû à un syndrome de Gilbert)
    - Clearance de la créatinine (selon Cockcroft-Gault ou MDRD) < 30 mL/min.
    • Envahissement neuroméningé
    • Contre-indication pour la prise d'un traitement prophylactique de la thrombose veineuse profonde
    • Antécédent de cancer autre que le lymphome du manteau sauf si le sujet est dépourvu de la maladie depuis plus de 5 ans (Exception: carcinome basocellulaire cutané, in-situ utérin ou du sein, cancer de la
    prostate (stade TNM T1a ou T1b).
    • Pathologie sérieuse, anomalie biologique ou maladie psychiatrique empêchant le sujet de recevoir le traitement à l'essai comme prévu.
    • Insuffisance cardiaque (fraction d'éjection ventriculaire gauche
    <50%) à l'échographie
    • sérologie HIV positive, hépatite B ou C active
    • Pathologie sérieuse non contrôlée incluant mais non limité à:
    - Infection active nécessitant une antibiothérapie parentérale
    - Diabète non contrôlé - Défaillance cardiaque congestive
    symptomatique chronique (NYHA III ou IV).
    - Angine de poitrine instable, angioplastie, stent ou infarctus du myocarde dans les 6 mois
    - Arythmie cardiaque cliniquement significative qui est symptomatique, requière un traitement, ou tachycardie ventriculaire asymptomatique
    prolongée.
    • Réaction d'hypersensibilité à la thalidomide ≥ Grade 3.
    • Rash ou desquamation pendant la prise de thalidomide≥ Grade 3.
    • Neuropathie ≥ Grade 2.
    • Hypersensibilité connue à un anticorps murin
    • Traitement antérieur par lenalidomide.
    • Participation à un autre essai clinique dans les 3 semaines précédant la randomisation dans l'étude.
    Critères additionnels pour la randomisation en maintenance :
    - maladie stable ou progression après le traitement d'induction évalué par l'investigateur selon les critères de Cheson, 1999
    - Patient n'ayant pas reçu au moins 6 cycles de R-CHOP ou 2 cycles of R-CHOP21 / 2 cycles of R-HAD28 alternés
    - Pathologie sérieuse sous-jacentes, qui pourrait empêcher le patient de recevoir le traitement de maintenance
    - Clearance de la créatinine (selon Cockcroft-Gault ou MDRD) < 30 mL/min.
    - Neutrophiles < 1,000 /mm³ (1.0 X 109/L);
    - Plaquettes < 50,000 /mm³ (50 X 109/L).
    E.5 End points
    E.5.1Primary end point(s)
    progression free survival (PFS).
    Survie sans progression
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization for maintenance to progression or death from any cause.
    Tumor assessment (clinical examination, laboratory tests, CT scan, bone marrow examination) will be performed at baseline, at the end of induction and of maintenance and every 6 months during maintenance and follow-up period.
    Depuis la randomisation pour le traitement de maintenance jusqu'à progression ou décès quelque soit la cause.
    L'évaluation de la tumeur (examen clinique, test de laboratoire, scanner, biopsie de moelle osseuse) sera faite en baseline, en fin de traitement
    d'induction et de maintenance et tous les 6 mois pendant la maintenance et la période de suivi.
    E.5.2Secondary end point(s)
    - Time to event
    • overall survival from induction randomization to death from any cause
    • overall survival from maintenance randomization to death from any cause
    • time to treatment failure, progression free survival from induction randomization, remission duration
    - PR/CRu to CR and PR to CRu conversion during maintenance
    - complete and overall response rates (based on Cheson 1999 criteria) at midterm and end of induction,
    - safety according to NCI CTCAE (v 4.0)
    - secondary primary malignancies rates after lenalidomide vs. no lenalidomide
    - Minimal residual disease (MRD) levels in peripheral blood and bone marrow at midterm and at the end of induction, after one and two years of maintenance and during follow-up until progression or 2.5 year after randomization of last patient in maintenance whichever comes first
    • Exploratory : response assessment according to Cheson 2007 criteria including FDG-PET evaluation
    • Survie globale depuis la randomisation pour l'induction jusqu'au décès quelle qu'en soit la cause
    • Survie sans progression à partir de la randomisation pour la maintenance jusqu'au décès quelle qu'en soit la cause
    • Temps jusqu'à l'échec du traitement, survie sans progression depuis la randomisation d'induction, durée de rémission
    - Conversion RP/RCi en RC et RP en RCi pendant la maintenance
    - Taux de réponse complète et taux de réponse (selon les critères de Cheson 1999) à l'évaluation de mi-traitement d'induction et en fin d'induction
    - Tolérance selon les NCI CTCAE (v 4.0)
    - Taux de cancers secondaires après lenalidomide vs. sans lenalidomide
    - Maladie résiduelle minimale (MRD) dans le sang périphérique et la moelle osseuse à mi traitement d'induction, à la fin du traitement d'induction, après 1 et 2 ans de traitement de maintenance et au cours du suivi jusqu'à progression ou jusqu'à 2,5 ans après la randomisation du dernier patient en maintenance
    - Exploratoire : Evaluation de la réponse selon Cheson 2007 (incluant l'évaluation par TEP scan)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • investigator-assessed progression free survival: from randomization for maintenance
    • overall survival: from first randomization to death from any cause
    • remission rates, time to treatment failure, remission duration: all duration of the study
    • minimal residual disease (MRD) levels: at end of induction, after one and two years of maintenance
    • safety according to NCI CTCAE (v 4.0): all duration of the study
    • PR to CR conversion: during maintenance
    • the rates of secondary neoplasias after lenalidomide vs. no lenalidomide: after starting maintenance treatment
    • Survie sans progression évaluée par l'investigateur: depuis la randomisation pour la maintenance
    • Survie globale: depuis la 1ère randomisation jusqu'au décès quelle qu'en soit la cause
    • taux de rémission, temps jusqu'à l'échec du traitement, durée de rémission: tout au long de l'étude
    • Maladie résiduelle minimale (MRD): à la fin de l'induction, après 1 et 2 ans de maintenance
    • Tolérance selon les NCI CTCAE (v 4.0): tout au long de l'étude
    • Conversion RP/RCi en RC et PR en Rci pendant la maintenance
    • Taux de cancers secondaires après lenalidomide vs. sans lenalidomide: à partir du début du traitement de maintenance
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA180
    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
    Last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    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) Yes
    F.1.2.1Number of subjects for this age range: 183
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 633
    F.4.2.2In the whole clinical trial 633
    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)
    no difference
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation MCL Network
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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