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    Summary
    EudraCT Number:2009-017269-49
    Sponsor's Protocol Code Number:IC 2009-06
    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:2010-01-04
    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 number2009-017269-49
    A.3Full title of the trial
    Etude de phase II d’évaluation de la toxicité et de l’efficacité d’un traitement par Tacrolimus (Prograf®) chez des patients atteints d’un lymphome diffus à grandes cellules B ou T.
    A.3.2Name or abbreviated title of the trial where available
    LY-PROGRAPH
    A.4.1Sponsor's protocol code numberIC 2009-06
    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 SponsorINSTITUT CURIE
    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 PROGRAF®
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.3
    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) 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 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
    Lymphomes malins diffus à grandes cellules B ou T.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10025311
    E.1.2Term Lymphoma (non-Hodgkin's)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation de la toxicité (classification CTC-AE version 3.0) et de l’efficacité anti-tumorale (critères de Cheson) 3 mois après la mise en route d’un traitement par Tacrolimus chez des patients porteurs de lymphomes malins diffus à grandes cellules B ou T et dont la voie calcineurine/NFAT est activée.
    E.2.2Secondary objectives of the trial
    • Détermination de la durée de réponse au Tacrolimus chez les patients en rémission complète, ou en réponse partielle, ou stables lors de l’évaluation réalisée 3 mois après la mise en route du traitement.
    • Détermination de la survie sans événement et de la survie globale à 3 ans des patients traités par Tacrolimus.
    • Corrélation entre le sous-type histologique du lymphome et la réponse au Tacrolimus, en y incluant le phénotype «centre germinatif» ou «cellules activées» des lymphomes diffus B à grandes cellules, ainsi qu’une étude des sous-populations lymphocytaires et des cellules stromales.
    • Pharmacologie du Tacrolimus chez des patients porteurs de lymphomes malins diffus à grandes cellules B ou T.
    • Immuno-monitoring des patients sous Tacrolimus (phénotypage des sous-populations cellulaires, cytokines).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Etude anatomo-pathologique. L’étude comportera :

    1. Une caractérisation du phénotype ‘’Germinal center ‘’ like des lymphomes B diffus à grandes cellules par une analyse de l’expression de Bcl-2, du CD10, de Bcl-6 et de MUM1.

    2. Une évaluation histologique de la réaction stromale lymphocytaire T et à cellules folliculaires dendritiques par une analyse de l’expression du CD4, du CD5, du CD8, du CD57, du CNA42 et du CD23.
    E.3Principal inclusion criteria
    • Patients porteurs d’un lymphome malin non-Hodgkinien diffus à grandes cellules B ou T (T périphériques, lymphadénopathie angio-immunoblastique (LAI), lymphomes anaplasiques à grandes cellules T ou nuls) prouvé histologiquement par une biopsie tumorale typé selon la classification OMS (Harris et al. 1999).
    • Patients porteurs d’un lymphome avec activation constitutive de la voie calcineurine/NFAT (Analyse immunohistochimique de l’expression du facteur NFAT2).
    • Patients ayant reçu au minimum 2 lignes et au maximum 4 lignes de traitement. Les patients porteurs d’un lymphome B devront avoir reçu du Rituximab. De même, les patients pouvant bénéficier d’une intensification thérapeutique avec autogreffe de cellules souches hématopoïétiques ne pourront pas être inclus dans l’étude, sauf en cas de contre-indication à la procédure ou de refus personnel.
    • Age supérieur à 18 ans.
    • PS 0 à 2.
    • Espérance de vie > 3 mois.
    • Maladie évaluable par au moins une cible tumorale.
    • Patients ayant donné leur consentement éclairé écrit.
    E.4Principal exclusion criteria
    • Traitements spécifiques du lymphome malin. Un délai de 4 semaines sera exigé entre la fin du traitement précédent et la mise en route du traitement expérimental.
    • Patients ayant une sérologie VHC ou VIH positive. Patients porteurs d’une hépatite chronique B.
    • Contre-indication au Tacrolimus (Prograf®) : hypersensibilité connue au Tacrolimus ou à d’autres macrolides, ou à l’un des composants.
    • Altération de la fonction rénale (créatinine > 2 fois la normale).
    • Altération du bilan hépatique (bilirubine totale > 30 mmol/l, transaminases > 2.5 fois la normale).
    • Altération de la fonction hématologique (polynucléaires neutrophiles < 1000.106/l, plaquettes < 50.109/l).
    • Antécédents cardiaques, respiratoires, neurologiques et psychiatriques graves.
    • Patients ayant un autre cancer évolutif sauf cancer du sein in situ ou cancer du col de l’utérus in situ ou carcinome basocellulaire cutané.
    • Traitement(s) concomitant(s) incompatible(s) : kétoconazole, millepertuis, stitipendol et ciclosporine.
    • Infection évolutive.
    • Patient déjà inclus dans un autre essai thérapeutique avec une molécule expérimentale.
    • Femme enceinte, susceptible de l’être ou en cours d'allaitement.
    • Personnes privées de liberté ou sous tutelle.
    • Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques.
    E.5 End points
    E.5.1Primary end point(s)
    Les critères de réponse tumorale seront codifiés selon les recommandations publiées pour les lymphomes malins (Cheson et al. 2007) et définis dans le synopsis et dans le protocole.
    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.6.13.1Other scope of the trial description
    Pharmacologie
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned6
    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 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
    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) 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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state34
    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 Decision2010-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-28
    P. End of Trial
    P.End of Trial StatusOngoing
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