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    Summary
    EudraCT Number:2007-003821-25
    Sponsor's Protocol Code Number:CHUBX 2007/11
    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:2007-08-21
    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 number2007-003821-25
    A.3Full title of the trial
    Etude de la tolérance et de l'efficacité du Zevalin dans un conditionnement à intensité réduite avant allogreffe de cellules souches hématopoïétiques dans les lymphomes B CD20+ agressifs de l'adulte, en rechute sensible : étude de phase II
    A.3.2Name or abbreviated title of the trial where available
    Zevallo 2007
    A.4.1Sponsor's protocol code numberCHUBX 2007/11
    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 SponsorCHU de Bordeaux
    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 Ibritumomab Tiuxetan (Zevalin)
    D.2.1.1.2Name of the Marketing Authorisation holderBayer-Schering Pharma
    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.3.4Pharmaceutical form Intravenous infusion
    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.3.8INN - Proposed INNIbritumomab tiuxétan
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/kg millicurie(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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) 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 Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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 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
    L’association du Zevalin®, anticorps monoclonal anti-CD20 radio marqué, à une chimiothérapie immunosuppressive permettrait d’accroître l’efficacité d’un conditionnement à intensité réduite à base de fludarabine avant allogreffe de cellules souches hématoïétiques dans les lymphomes B CD20+ agressifs de l'adulte.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012820
    E.1.2Term Diffuse large B-cell lymphoma NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10026799
    E.1.2Term Mantle cell lymphoma NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L’objectif principal de l’étude est d’évaluer la toxicité précoce en terme de mortalité liée à la procédure thérapeutique associant un conditionnement atténué à base de Fludarabine à du Zevalin® à J100 post greffe.
    E.2.2Secondary objectives of the trial
    Les objectifs secondaires sont :
    - Evaluer la survie globale à 1 an
    - Evaluer la survie sans événement à 1 an du conditionnement atténué à base de Fludarabine associé à du Zevalin® (est considéré comme événement : décès de toute cause, rechute ou progression de la maladie, nécessité d’un nouveau traitement)
    - Evaluer le taux de reconstitution hématologique définie par un taux de polynucléaires neutrophiles > 500/mm3 et de plaquettes > 20 000/mm3 pendant 3 jours consécutifs, sans facteurs de croissance hématopoïétiques ni support transfusionnel plaquettaire, après un conditionnement atténué à base de Fludarabine associé à du Zevalin® à J30
    - Evaluer les effets biologiques du Zevalin® en post-greffe : incidence de la GVH, récupération immunologique B et T à J28, J90, J180 et 1 an
    - Evaluer le chimérisme à J28, J56 et J90, J180 et 1 an
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients d’âge ≥ 18 ans et ≤ 65 ans
    - Lymphomes B diffus à grandes cellules CD20+ (LBDGC) en rechute après 2 lignes de traitement ou après une ligne comportant une autogreffe de cellules souches hématopoïétiques (CSH), ou
    - Lymphomes du manteau CD20+ (MCL) en rechute après 2 lignes de traitement ou après une ligne comportant une autogreffe de cellules souches hématopoïétiques (CSH)
    - Présence d’un donneur HLA identique intra ou non familial, sans mismatch
    - Indice ECOG (Eastern Cooperative Oncolgy Group) < 2 (annexe 4)
    - Ayant reçu ou non du Rituximab
    - Sensible à la chimiothérapie de rattrapage (réponse partielle > 50% selon les critères classiques de Cheson (annexe 5))
    - Eligible pour une allogreffe
    - Espérance de vie > 3 mois
    - Consentement libre éclairé et signé par le patient et l'investigateur (au plus tard le jour de la pré-inclusion et avant tout examen nécessité par l'étude)
    - Sujet affilié ou bénéficiaire d'un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Allogreffe antérieure
    - Autre maladie cancéreuse évolutive
    - Affection psychiatrique évolutive
    - Sérologie positive pour le virus de l’immunodéficience humaine ou hépatite C évolutive nécessitant un traitement
    - Insuffisance rénale sévère définie par une clairance de la créatinine < 30 ml/mn
    - Femmes enceintes ou allaitant, ou absence de contraception efficace
    - Contre-indications habituelles à la greffe allogénique en particulier :
    ->Cardiaque : fraction d’éjection systolique < 50%
    ->Respiratoire avec une DLCO limitant l’emploi de fludarabine et de busulfan (<50% de la théorique)
    ->Rénale avec une clairance de la créatinine < 30 ml/mn
    ->Hépatique : transaminases et/ou bilirubine supérieures à 2 fois la normale en dehors d’une atteinte hépatique spécifique due au lymphome
    - Personnes placées sous sauvegarde de justice
    E.5 End points
    E.5.1Primary end point(s)
    -> Critère de jugement principal :
    Le critère de jugement principal est la mortalité à J100 de la greffe.
    On entend par mortalité tout décès toxique survenant dans les 100 premiers jours qui suivent le début du conditionnement sauf si celui-ci peut être attribué de manière exclusive au lymphome

    -> Principaux critères de jugement secondaires:
    - Survenue dans la première année d’un décès, quelle que soit la cause
    - Survenue dans la première année d’un décès quelle que soit la cause, d’une rechute ou progression de la maladie, de la prise d’un nouveau traitement en dehors de la réinjection de lymphocytes du donneur
    - L’incidence de la GVH.
    - Le taux de polynucléaires neutrophiles et le taux de plaquettes à J30
    - Le taux de lymphocyte B et T à J30, J100, 6 mois et 1 an
    - Le chimérisme à J30, J60 et J100, 6 mois et 1 an
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 concerned3
    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 Information not present in EudraCT
    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
    La fin de l'étude est prévue un an après la greffe du dernier patient.
    En effet, la dernière visite de suivi des patients se fait à un an après la greffe.
    La durée prévisionnelle de l'étude est de 3 ans.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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.1.3Elderly (>=65 years) No
    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 state30
    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 Decision2007-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-29
    P. End of Trial
    P.End of Trial StatusOngoing
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