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    Summary
    EudraCT Number:2006-004768-30
    Sponsor's Protocol Code Number:MANTEAU 2006 SA
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-02-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-004768-30
    A.3Full title of the trial
    Traitement de première ligne des lymphomes du manteau de patients agés de 65 à 80 ans. Evaluation de l'efficacité, de la toxicité et de facteurs pronostiques moléculaires de l'inhibiteur du protéasome ( PS341-Velcade) associé à une chimiothérapie et une immunothérapie par rituximab ( schéma RiPAD + C)
    A.3.2Name or abbreviated title of the trial where available
    MANTEAU 2006 SA
    A.4.1Sponsor's protocol code numberMANTEAU 2006 SA
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGOELAMS
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameVELCADE
    D.3.2Product code PS341, 26866138-AAA-PB-001
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameBORTEZOMIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Patient porteur d'un lymphome du manteau au diagnostic entre 60 et 80 ans
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tester l'efficacité du schéma RiPAD+C dans le cadre du traitement en première ligne de patients porteurs de lymphomes du manteau, agés de 65 à 80 ans. Le critère principal sera le taux de réponse globale après le quatrième cycle de RiPAD+C.
    E.2.2Secondary objectives of the trial
    -L'évaluation du taux de réponse complète ( RC) et du taux de réponse complète non confirmée ( RCu) après 4 cycles de Ripad, selon cheson 1999.
    -L'évaluation des taux de RC et rémission partielle évalué par une tomographie par émission de positron ( TEP) après 4 cycles.
    -L'évaluation de facteurs pronostiques cliniques et biologique de la réponse au traitement.
    -L'évaluation des survies ( Survie globale, survie sans progression, survie sans évènement, survie sans maladie)
    -L'évaluation de la maladie résiduelle en biologie moléculaire, en cytométrie en flux et par hybridation in situ fluorescente sur sang et/ou moelle.
    -La recherche des marqueurs tumoraux biologiques par étude transcriptomique et protéomique
    -la constitution d'une tumorothèque.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmation du diagnostic de lymphome du manteau selon les critères de l’OMS, dans toutes ces variantes : formes classiques et variantes blastoïdes.
    - Un immunophénotypage minimal initial est obligatoire et inclura CD20 et CD5
    - CD20+
    - Avec la preuve de l’existence d’une t (11 ;14) apportée par un caryotype, une étude en FISH ou en biologie moléculaire.
    - En première ligne de chimiothérapie.
    - Avec au moins un site tumoral accessible à l’évaluation, non exclusivement médullaire. Les patients avec uniquement une atteinte sanguine et médullaire et/ou splénique sont exclus.
    - Agés de plus de 65 ans et de moins de 81 ans
    - ECOG 0-1 ou 2
    - Pas d’autres néoplasies en dehors d’un carcinome basocellulaire réséqué ou d’un néoplasme in situ.
    - Ayant signé un consentement éclairé
    - Fraction d’éjection ventriculaire  50% mesurée par une méthode échographique ou scintigraphique
    - Absence de contre indication à l’utilisation des drogues contenues dans le schéma (Rituximab, Bortezomib, Adriblastine, dexaméthasone, Chlorambucil)
    - Avec les valeurs biologiques limites suivantes sauf si les valeurs pathologiques sont relatives au lymphome:
    - Polynucléaires neutrophiles 1,5 G/L
    - Plaquettes 100 G/L
    - Transaminases (SGOT et SGPT) 3 x normale (N)
    - Bilirubine  2 x N
    - Clairance créatinémie calculée  50 mL/min
    E.4Principal exclusion criteria
    - Autres types de lymphome que lymphome du manteau selon classification OMS.
    - Patient en rechute, sauf une rechute après un stade localisé n’ayant reçu antérieurement qu’une irradiation loco-régionale ou ayant été splénectomisé.
    - Localisation médullaire exclusive
    - Localisation au système nerveux central notamment méningé
    - Contre indication à l’une des drogues utilisées dans le schéma (Rituximab, Bortezomib, Adriblastine, dexaméthasone, Chlorambucil)
    - Diabète non équilibré
    - Allergie connue au Chlorambucil

    - VIH + ou hépatite C ou B active
    - Mauvais état général : ECOG  3 (cf annexes)
    - Neuropathie périphérique, quelque soit son origine, cotée > 2 sur l’échelle du NCI (cf annexes)
    - Patient n’ayant pas signé de consentement éclairé.
    - Patient ne pouvant, pour quelques raisons que se soient, être contraint à une surveillance régulière.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal sera le taux de réponse globale après le quatrième cycle de RiPAD+C.
    Les critères de réponse seront ceux définis par le workshop de 1999 46 pour permettre une comparaison avec les données de la littérature.
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned38
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.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 state39
    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 Decision2007-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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