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    Summary
    EudraCT Number:2017-001465-24
    Sponsor's Protocol Code Number:GC-LTFU-001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-10-03
    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 number2017-001465-24
    A.3Full title of the trial
    Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.
    Protocole de suivi à long terme pour les patients traités par des cellules T génétiquement modifiées.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.
    Protocole de suivi à long terme pour les patients traités par des cellules T génétiquement modifiées.
    A.4.1Sponsor's protocol code numberGC-LTFU-001
    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 SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888260 1599
    B.5.5Fax number+1913266 0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    D. IMP Identification
    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
    Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.
    Initially it is planned to enroll patients from parent studies BB2121-MM-001 (EudraCT 2017-002245-29; for adult patients with relapsed and refractory multiple myeloma) and JCAR017-BCM-001 (EudraCT 2017-000106-38; for adult subjects with aggressive B-Cell Non-Hodgkin Lymphoma).
    E.1.1.1Medical condition in easily understood language
    Defined by parent protocol
    Définie dans le protocole principal.
    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 LLT
    E.1.2Classification code 10025631
    E.1.2Term Malignant lymphoid neoplasm NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the risk of delayed adverse events (AEs) following exposure to gene-modified (GM) T cells
    - To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate.
    - To monitor for generation of replication competent retroviruses (RCR)
    - To assess long-term efficacy following treatment with GM T cells
    - Describe growth, developmental outcome, and sexual maturity status for subjects who were aged < 18 years at time of GM T cell treatment
    - To assess long term health-related quality of life following treatment with GM T cells
    Évaluer le risque d'événements indésirables (EI) différés après l'exposition aux cellules T GM.
    Surveiller la persistance à long terme des cellules T GM, notamment analyser les sites avec vecteur d'intégration, selon le cas.
    Surveiller la génération de rétrovirus compétents pour la réplication (RCR).
    Évaluer l'efficacité à long terme après un traitement par cellules T GM.
    Décrire la croissance, les résultats de développement et l'état de maturité sexuelle chez les patients de moins de 18 ans au moment du traitement par cellule T GM.
    Évaluer la qualité de vie à long terme liée à la santé après un traitement par cellules T GM.
    E.2.2Secondary objectives of the trial
    None
    Aucun
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All adult and pediatric subjects who received at least one gene-modified (GM) T cell infusion in a previous Celgene sponsored or Celgene alliance partner sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
    2. Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an ICF/IAF prior to any study-related assessments/procedures being
    conducted.
    3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
    1. Tous les patients adultes et pédiatriques ayant reçu au moins une perfusion de cellules T GM au cours de l'étude commanditée par Celgene ou un partenaire de Celgene, et ayant arrêté ou mené à terme la période de suivi post-thérapeutique dans le cadre du protocole thérapeutique
    principal, selon le cas.
    2. Le patient (et le représentant légal ou parental le cas échéant) doit comprendre et signer volontairement un FCE avant la réalisation de toute évaluation ou procédure liée à l'étude.
    3. Le patient accepte et est capable de respecter le calendrier des visites d'étude et les autres exigences du protocole.
    E.4Principal exclusion criteria
    Not Applicable.
    Pas applicable
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    - Incidence of delayed Adverse Events suspected to be related to prior gene-modified (GM) T cell therapy, including:
    - New malignancies (hematologic or solid)
    - New neurologic disorder, or exacerbation of a pre-existing neurologic disorder
    - New rheumatologic or autoimmune disorder, or exacerbation of a prior rheumatologic or other autoimmune disorder
    - New hematologic disorder
    - Other new clinical conditions considered related to the prior GM T cell therapy by the investigator.
    Hospitalizations, regardless of relationship to prior treatment, including reasons and dates

    - Persistence of GM T cells
    - Analysis of vector integration sites
    - Incidence of replication-competent retroviruses (RCR)
    - Height, weight, growth, and organ development will be assessed for all pediatric subjects
    - Sexual maturity status for pediatric subjects

    Efficacy
    Where applicable:
    - Tumor Response Status
    - Date of Disease Progression
    - Date of Relapse
    - Survival Status

    HRQoL
    Measurement of health-related quality of life (HRQoL) changes as assessed using instruments administered in the parent treatment protocol
    Innocuité:
    - Incidence des événements indésirables tardifs que l'on soupçonne être en rapport avec le traitement par lymphocytes T génétiquement modifiés (GM), notamment :
    - Nouvelles tumeurs malignes (tumeurs hématologiques ou solides)
    - Nouveau trouble neurologique ou exacerbation d'un trouble neurologique préexistant
    - Nouveau trouble rhumatologique ou auto-immun, ou exacerbation d'un trouble rhumatologique ou autre trouble auto-immun antérieur
    - Nouveau trouble hématologique
    - Autres nouvelles conditions cliniques jugées en rapport avec le traitement par lymphocytes T GM antérieur, de l'avis de l'investigateur.
    Hospitalisations, indépendamment de tout rapport avec un traitement antérieur, incluant motifs et dates.
    - Persistance de lymphocytes T GM
    - Analyse des sites d'intégration de vecteurs
    - Incidence des rétrovirus compétents pour la réplication (RCR)
    - La taille, le poids, la croissance et le développement des organes seront évalués chez tous les patients pédiatriques.
    - Statut de la maturité sexuelle pour les patients pédiatriques
    Efficacité
    Le cas échéant :
    - Statut de la réponse tumorale
    - Date de la progression de la maladie
    - Date de la rechute
    - Statut de la survie
    - QdVLS
    Mesure des modifications de la qualité de vie liée à la santé (QdVLS) évaluées à l'aide instruments administrés dans le cadre du protocole thérapeutique principal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    HRQoL: Up to 5 years from last GM T cells infusion
    Other endpoints: Up to 15 years from last GM T cells infusion
    HRQoL: jusqu'à 5 ans après la dernière perfusion de cellules T GM.
    Autres paramètres: jusqu'à 15 ans après la dernière perfusion de cellules T.
    E.5.2Secondary end point(s)
    Not Applicable.
    Pas applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable.
    Pas applicable
    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 Yes
    E.6.13.1Other scope of the trial description
    Health-related quality of life (HRQoL)
    Questionnaire qualité de vie lié à la santé (QdVLS).
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Protocole de suivi à long terme
    Long-Term Follow-up Protocol
    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.8.2.4Number of treatment arms in the trial0
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Canada
    Finland
    France
    Germany
    Italy
    Japan
    Netherlands
    Spain
    Switzerland
    United Kingdom
    United States
    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
    The End of Trial is defined as either the date of the last visit of the last subject or the date of receipt of the last data point from the last subject that is required for primary analysis, as pre-specified in the protocol, whichever is the later date.
    La fin de l’étude se définit soit comme la date de la dernière visite du dernier patient, soit comme la date de réception du dernier point de données du dernier patient requis pour l’analyse principale, tel que prédéterminé dans le protocole, l’échéance la plus lointaine étant retenue.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    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 years15
    E.8.9.2In all countries concerned by the trial months0
    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) Yes
    F.1.2.1Number of subjects for this age range: 118
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 159
    F.4.2.2In the whole clinical trial 218
    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
    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 Decision2018-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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