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    The EU Clinical Trials Register currently displays   35907   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001673-14
    Sponsor's Protocol Code Number:CCTL019A2205B
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-08-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-001673-14
    A.3Full title of the trial
    Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CAR T-Cell Therapy
    Seguimiento a largo plazo (LTFU) de pacientes tratados con la terapia celular CART dirigida a CD19 basada en vectores lentivirales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long term follow-up study for patients who have been treated with lentivirus-based chimeric antigen receptor (CAR) T-Cell Therapy directed against CD19
    Estudio de seguimiento a largo plazo para los pacientes que han sido tratados con receptor de antígeno quimérico basado en lentivirus (CAR) Terapia de células T dirigida contra CD19
    A.3.2Name or abbreviated title of the trial where available
    CD19 CART Long Term Follow Up (LTFU) study
    Estudio de seguimiento a largo plazo de CD19 CART
    A.4.1Sponsor's protocol code numberCCTL019A2205B
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02445222
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico Oncología (GMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.com
    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 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 nameCTL019
    D.3.2Product code CTL019
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 INNCélulas Linfocitos T diferenciadas adultas autólogas de sangre periférica expandidas infectadas con un vector lentiviral expresando un CAR
    D.3.9.1CAS number CTL019
    D.3.9.2Current sponsor codeCTL019
    D.3.9.3Other descriptive nameCélulas Linfocitos T diferenciadas adultas autólogas de sangre periférica expandidas infectadas con un vector lentiviral expresando un CAR
    D.3.9.4EV Substance CodeSUB176601
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2000000 to 250000000
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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) Yes
    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 Yes
    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
    Patients who have been treated for a B cell hematological malignancy in a Novartis sponsored or supported study of CD19 directed CAR T-Cell treatment are enrolled in this study following completion or early discontinuation from the Novartis sponsored or supported study of CD19 directed CAR T-Cell treatment.
    Pacientes que han recibido tratamiento para una enfermedad maligna hematológica de células B en un estudio patrocinado por Novartis de CD19 dirigidos al tratamiento de células CAR T serán los reclutados en este estudio después de la terminación o discontinuación temprana del estudio patrocinado por Novartis de CD19 dirigidos al tratamiento de células CAR T
    E.1.1.1Medical condition in easily understood language
    Patients who have been treated in a Novartis sponsored or supported study with a CD19 directed chimeric antigen receptor (CAR) T-cell treatment for a B cell malignancy
    Pacientes que han sido tratados en un estudio patrocinado por Novartis para el tratamiento de las células T con un CD19 receptor de antígeno quimérico (CAR) para una neoplasia maligna de células B
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10003917
    E.1.2Term B-cell type acute leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10003899
    E.1.2Term B-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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to monitor all patients exposed to CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs).
    Monitorizar a todos los pacientes expuestos a células T modificadas con CAR dirigidas a CD19 (CD19 CART) durante 15 años después de la última infusión de CD19 CART (p. ej., CTL019) para evaluar el riesgo de acontecimientos adversos (AAs) tardíos
    E.2.2Secondary objectives of the trial
    - Monitor the persistence of CD19 CAR transgene
    - Monitor for replication competent lentivirus (RCL)
    - Assess the long-term efficacy of CD19 CART
    ? Monitorizar la persistencia del transgén CD19 CAR en sangre periférica
    ? Monitorizar la expresión de LCR (lentivirus competentes para replicación)
    ? Evaluar la eficacia a largo plazo de CD19 CART, incluida la proporción de pacientes que experimentan recidiva o progresión entre los pacientes que no habían experimentado recidiva o progresión en la inclusión/reinclusión en el estudio, y la incidencia de fallecimientos
    ? Monitorizar los niveles de linfocitos
    ? Describir el crecimiento, el desarrollo y el estado reproductor de las pacientes que tenían < 18 años en el momento de la infusión inicial de CD19 CART
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - All patients who have received anti-CD19 directed CART therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CD19-directed CART cells or from any CD19 CART trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology.
    - Patients who have provided informed consent for the long term follow up study prior to their study participation .
    ? Todos los pacientes que recibieron terapia CART dirigida a CD19 y que la completaron o interrumpieron prematuramente procedentes de un protocolo de tratamiento patrocinado por Novartis en el que se utilizó terapia celular CART dirigida a CD19 o procedentes de algún ensayo con CD19 CART patrocinado por la Universidad de Pennsylvania con la que Novartis ha firmado un contrato para el codesarrollo de la tecnología CAR.
    ? Pacientes que han proporcionado el consentimiento informado para el estudio de seguimiento a largo plazo antes de su participación en el estudio.
    E.4Principal exclusion criteria
    - There are no specific exclusion criteria for this study.
    No existen criterios de exclusión específicos para este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with listed categories:
    - New malignancies
    - Incidence/exacerbation of pre-existing neurologic disorder
    - New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
    - New incidence of a hematologic disorder
    Proporción de pacientes con categorías enumeradas:
    - Nuevos procesos malignos
    - Incidencia / exacerbación de la preexistente trastorno neurológico
    - Nueva incidencia o exacerbación de un trastorno autoinmune reumatológicos u otro antes
    - Nueva incidencia de un trastorno hematológico
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: 3 monthly until year 1, 6 monthly until year 5, yearly until year 15.
    Plazo: 3 mes hasta el primer año, 6 meses hasta 5 años, anualmente hasta el año 15.
    E.5.2Secondary end point(s)
    ?Proportion of patients with detectable CD19 CAR transgene levels in peripheral blood by q-PCR at pre- specified post CD19 CART infusion time points
    - Proportion of patients with detectable RCL by VSV-G
    - Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry; Incidence of death.
    - Absolute B- and T- lymphocyte count
    - Height and weight, Tanner staging, menstrual cycle status
    ? Proporción de pacientes con CD19 detectable niveles transgenes CAR en sangre periférica por q-PCR en pre poste CD19 especificado los puntos de tiempo de infusión Carro
      - Proporción de pacientes con detectable RCL por VSV-G
    - Proporción de pacientes que recaen o de progreso entre los pacientes que no habían recaído o progresado al inicio del estudio / reingreso; La incidencia de muerte.
      - Absolute B y recuento de linfocitos T
      - Altura y peso, Tanner puesta en escena, el estado del ciclo menstrual
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time Frame: 3 monthly until year 1, 6 monthly until year 5, yearly until year 15.
    Plazo: 3 mes hasta el primer año, 6 meses hasta 5 años, anualmente hasta el año 15.
    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 Yes
    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) 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Austria
    Belgium
    Canada
    France
    Germany
    Italy
    Netherlands
    Norway
    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 the LTFU study for each individual patient will be 15 years after the date of patients? last infusion of CD19 CART. The end of study as a whole is defined as the last patient?s last visit (LPLV), which is the last
    patient?s last evaluation (visit Year 15), or the time of premature withdrawal.
    El fin del estudio de LTFU para cada paciente individual será de 15 años después de la fecha de la última infusión de CD19 CART del paciente. Debería cumplimentarse una página del CRD de final de la disposición del seguimiento postratamiento, anotando la fecha y el motivo para la interrupción del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years20
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years20
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In cases where the patient's representative gives consent, the patient
    will be informed about the study to the extent possible given his/her
    understanding.
    En los casos en que el representante del paciente da su consentimiento, el paciente será informado sobre el estudio a la medida de lo posible dado su entendimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 500
    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
    Ninguno
    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 Decision2015-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
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