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    The EU Clinical Trials Register currently displays   42771   clinical trials with a EudraCT protocol, of which   7044   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-000297-38
    Sponsor's Protocol Code Number:CL1-68587-003
    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:2018-10-25
    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 number2016-000297-38
    A.3Full title of the trial
    Long-term follow-up study of patients who have previously been exposed to UCART19 (allogeneic engineered T-cells expressing a lentiviral-based anti-CD19 chimeric antigen receptor)
    Estudio de seguimiento a largo plazo de pacientes que han sido previamente expuestos a UCART19 (células T alogénicas modificadas que expresan un receptor antigénico quimérico anti-CD19 basado en lentivirus)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19
    Estudio para evaluar la seguridad a largo plazo de pacientes con leucemia linfoblástica a los que se les ha administrado UCART19 como terapia previa.
    A.4.1Sponsor's protocol code numberCL1-68587-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02735083
    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 SponsorInstitut de Recherches Internationales Servier (I.R.I.S)
    B.1.3.4CountryFrance
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherches Internationales Servier (I.R.I.S)
    B.5.2Functional name of contact pointClinical Studies Department
    B.5.3 Address:
    B.5.3.1Street Address50 rue Carnot
    B.5.3.2Town/ citySuresnes
    B.5.3.3Post code92284
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 155724366
    B.5.5Fax number+33 155725412
    B.5.6E-mailclinicaltrials@servier.com
    B.Sponsor: 2
    B.1.1Name of SponsorLaboratorios Servier S.L.
    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 supportLaboratorios Servier S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier S. L.
    B.5.2Functional name of contact pointDepartamento I+D
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de los Madroños 33
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917489670
    B.5.5Fax number+34913003249
    B.5.6E-mailmaria.dequintanabarajas@servier.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 nameUCART19
    D.3.2Product code S68587
    D.3.4Pharmaceutical form Infusion
    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 INNCD19CAR/RQR8+_TCRαβ-_T-cells
    D.3.9.2Current sponsor codeS68587
    D.3.9.3Other descriptive nameUCART19
    D.3.9.4EV Substance CodeSUB180949
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number600000 to 20000000
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberGene therapy medicinal product EMA/132648/2014
    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) No
    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
    Advanced lymphoid malignancies
    Tumores malignos linfoides
    E.1.1.1Medical condition in easily understood language
    Advanced lymphoid malignancies
    Tumores malignos linfoides
    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 10060390
    E.1.2Term Leukaemia lymphoblastic acute
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19.
    Evaluar la seguridad a largo plazo de los pacientes con neoplasias linfoides avanzadas a los que se les ha administrado previamente UCART19.
    E.2.2Secondary objectives of the trial
    - To assess the long-term anti leukemic activity (disease outcome, disease-free survival and overall survival),
    - To assess the proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation),
    - To assess the time to transplant,
    - To monitor the long-term persistence of UCART19 in blood,
    - To monitor the long-term persistence of UCART19 in bone marrow (if a bone marrow aspirate is collected by the centre as part of the routine care of the patient’s disease)
    - Evaluar la actividad antileucémica a largo plazo de UCART19 (supervivencia libre de progresión, supervivencia específica de enfermedad),
    - Evaluar la proporción de pacientes que son sometidos a un trasplante alogénico de células madre hematopoyéticas (alo-HSCT),
    - Evaluar el tiempo hasta el trasplante
    - Monitorizar la persistencia a largo plazo de UCART19 en sangre periférica,
    - Monitorizar la persistencia a largo plazo de UCART19 en médula ósea (si, como parte del cuidado rutinario del paciente en el centro, se recoge un aspirado de médula ósea
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative);
    - Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use);
    - Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners.
    - Consentimiento informado por escrito obtenido antes de la realización de cualquier procedimiento específico del estudio (paciente, progenitor o representante legal)
    - Pacientes que han recibido UCART19 que han completado o abandonado prematuramente un estudio con promotor o cualquier estudio iniciado por un investigador que estudiaba UCART19, o pacientes a quienes se administró UCART19 en el marco de un esquema de acceso especial (uso compasivo)
    - En el marco de este estudio, las pacientes femeninas en edad fértil y los pacientes masculinos con parejas en edad fértil deben continuar utilizando un método efectivo de contracepción así como sus parejas,
    E.4Principal exclusion criteria
    No exclusion criteria for this study
    No hay criterios de exclusión para este estudio
    E.5 End points
    E.5.1Primary end point(s)
    The safety of UCART19 will be assessed throughout the study by evaluation of the following parameters:
    1- Number, duration, outcome of all adverse events (AE)
    2- Number, duration, outcome of AE of special interest regardless the relationship with UCART19 and any AE assessed as related to UCART19
    3- Number of AEs leading to death
    4- For paediatric patients: the potential impact on growth curve and puberty will be assessed by height, weight, Tanner staging and menstrual cycle status
    5- If an allo-HSCT is performed, engraftment will be assessed through the reporting of haematological data and chimerism status (if data available from the patient’s medical file)
    La seguridad de UCART19 se evaluará a lo largo del estudio, mediante los siguientes parámetros:
    1- Número, duración, desenlace de todos los acontecimientos adversos (AEs) ,
    2- Número, duración, desenlace de acontecimientos adversos de especial interés al margen de su relación con UCART19 y cualquier AE relacionado con UCART19
    3- Número de AEs que conlleven la muerte hasta el final del estudio
    4- En pacientes pediátricos se evaluará el potencial impacto sobre la curva de crecimiento y la pubertad mediante la altura, el peso, escala de Tanner y estatus del ciclo menstrual .
    5- Si se realiza un trasplante alogénico de células madre hematopoyéticas, se evaluará el éxito del injerto a través de la comunicación de datos hematológicos y del estado de quimerismo (si hay datos disponibles en la historia médica del paciente)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- within 12 months post last UCART19 infusion
    2- throughout the study
    3- up to the end of the study
    4- Month 3 post last UCART19 infusion, Month 6 and Month 12, then every 6 months up to Year 3, and yearly until Year 15
    5- Up to 3 months post allo-HSCT
    1- En los 12 meses que siguen a la última infusión de las UCART19
    2- A lo largo de todo el estudio
    3- Hasta el final del estudio
    4- En el mes 3 , mes 6, mes 12 tras la última infusión de las UCART19, después cada 6 meses hasta el año 3 y una vez al año hasta el año 15
    5- Hasta 3 meses post transplante
    E.5.2Secondary end point(s)
    - Proportion of patients who relapse or progress among patients who had not relapsed (progression-free survival, disease specific survival)
    - Duration of response from the date of first CR or CRi until the date of progression or death due to any cause, whichever occurs first.
    ­- Overall survival (OS)
    - Proportion of patients who underwent allogeneic HSCT and time to transplant
    - Proporción de pacientes que recaen o progresan versus los pacientes que no progresan (supervivencia libre de progresión, supervivencia específica de la enfermedad),
    Duración de la respuesta desde la fecha de CR o CRi hasta la fecha de progresión o muerte debida a cualquier causa, lo que ocurra primero.
    -Supervivencia global
    - proporción de pacientes que se someten a un trasplante alogénico de células madre hematopoyéticas y tiempo hasta el transplante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    M3 post last UCART19 infusion, M6 and M12, then every 6 months up to year 3, and yearly until year 15
    M3 tras la última infusión de UCART19, M6, M12 y después cada 6 meses hasta los tres años y una vez al año 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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I long term follow-up post UCART19 ADMINISTRATION
    Estudio de fase I de seguimiento a largo plazo tras administración de UCART19
    E.7.2Therapeutic exploratory (Phase II) No
    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 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 EEA7
    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
    Belgium
    France
    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
    LVLS
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years16
    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 years23
    E.8.9.2In all countries concerned by the trial months7
    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: 100
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minor subjects
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 172
    F.4.2.2In the whole clinical trial 200
    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 Decision2019-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
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