Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-002949-30
    Sponsor's Protocol Code Number:ATA129-EBV-302
    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:2019-12-20
    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 number2017-002949-30
    A.3Full title of the trial
    Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)
    Estudio de fase III, abierto y multicéntrico, de tabelecleucel para pacientes con trasplante alogénico de células hematopoyéticas o de órganos sólidos con enfermedad linfoproliferativa postrasplante asociada al virus de Epstein-Barr después del fracaso de rituximab o rituximab y quimioterapia (estudio ALLELE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for subjects after organ or cell transplantation after failure of prior treatment
    Un estudio para pacientes después de un transplante de órgano o de células y depués de fallo a un tratamiento previo.
    A.3.2Name or abbreviated title of the trial where available
    ALLELE study
    Estudio ALLELE
    A.4.1Sponsor's protocol code numberATA129-EBV-302
    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 SponsorAtara Biotherapeutics, Inc.
    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 supportAtara Biotherapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAtara Biotherapeutics, Inc.
    B.5.2Functional name of contact pointLan T Hoang
    B.5.3 Address:
    B.5.3.1Street Address2380 Conejo Spectrum Street, Suite 200
    B.5.3.2Town/ cityThousands Oaks
    B.5.3.3Post code91320
    B.5.3.4CountryUnited States
    B.5.4Telephone number1805309 2965
    B.5.5Fax number1888297 8163
    B.5.6E-maillhoang@atarabio.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1627
    D.3 Description of the IMP
    D.3.1Product nametabelecleucel
    D.3.2Product code ATA129
    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 INNTABELECLEUCEL
    D.3.9.2Current sponsor codeATA129
    D.3.9.4EV Substance CodeSUB194902
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50000000
    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 Yes
    D.3.11.3.2Gene therapy medical product No
    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 numberSomatic cell therapy medicinal product, 30 May 2016 Doc. Ref. EMA/CAT/327742/2016
    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 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
    Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease
    Enfermedad linfoproliferativa postrasplante asociada al virus de Epstein-Barr
    E.1.1.1Medical condition in easily understood language
    Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after failure of prior treatment
    Enfermedad linfoproliferativa postrasplante asociada al virus de Epstein-Barr después del fracaso del tratamiento previo
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10068349
    E.1.2Term Epstein-Barr virus associated lymphoproliferative disorder
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10075146
    E.1.2Term Post transplant Epstein-Barr virus associated lymphoproliferative disorder
    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 determine the clinical benefit of tabelecleucel (ATA129; allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes [EBV-CTLs]) in subjects with EBV-associated post-transplant
    lymphoproliferative disease (EBV+ PTLD) following (1) solid organ transplant (SOT) and after failure of rituximab (Subgroup A) and rituximab plus chemotherapy (Subgroup B) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab, as measured by the objective response rate (ORR).
    determinar el beneficio clínico de tabelecleucel (ATA129; linfocitos T citotoxicos alogénicos específicos contra el virus de Epstein-Barr [LTC-VEB]) en sujetos con enfermedad linfoproliferativa postrasplante asociada al virus de Epstein-Barr (ELP+ VEB) tras (1) el trasplante de órganos sólidos (TOS) y tras el fracaso de rituximab (subgrupo A) y rituximab más quimioterapia (subgrupo B) o (2) el trasplante de células hematopéyicas (TCH) alogénico tras el fracaso de rituximab, medido por la tasa de respuesta objetiva (TRO).
    E.2.2Secondary objectives of the trial
    - To evaluate duration of response (DOR) in the SOT and HCT cohorts separately
    - To evaluate ORR and DOR in the SOT and HCT cohorts combined
    - To evaluate rates of complete response (CR) and partial response (PR)
    - To evaluate time to response and time to best response
    - To evaluate overall survival (OS)
    - To evaluate graft status (SOT subjects only)
    - To characterize the safety profile of tabelecleucel in this subject population
    - Evaluar la duración de la respuesta (DdR) en las cohortes de TOS y TCH por separado
    - Evaluar la TRO y DdR en las cohortes de TOS y TCH combinadas
    - Evaluar las tasas de respuesta completa (RC) y respuesta parcial (RP)
    - Evaluar el tiempo hasta la respuesta y el tiempo hasta la mejor respuesta
    - Evaluar la supervivencia global (SG)
    - Evaluar el estado del injerto (solo sujetos con TOS
    - Definir el perfil de seguridad de tabelecleucel en esta población de sujetos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (SOT cohort);
    or prior allogeneic HCT (HCT cohort).
    2. A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD.
    3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.
    4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano
    Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For subjects with treated central nervous system (CNS) disease, head diagnostic CT
    and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.
    5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy
    (SOT subgroup A or HCT cohort) or rituximab plus any concurrent or sequentially administered
    chemotherapy regimen (SOT subgroup B) for treatment of PTLD. Treatment failure is defined based on rituximab response as follows:
    a.Radiographic disease progression per Lugano Classification following a minimum cumulative dose
    of 1125 mg/m2 rituximab (typically, 3 weekly doses of 375 mg/m2), or
    b. Failure to achieve CR or PR, defined by Lugano radiographic criteria, after a minimum cumulative dose of 1500 mg/m2 rituximab (typically, 4 weekly doses of 375 mg/m2), or
    c. Relapse/progression of PTLD after a response to rituximab (SOT subgroup A or HCT cohort) or
    rituximab plus chemotherapy (SOT subgroup B), defined as radiographic and/or biopsy evidence of relapse/progression consistent with PTLD; if the underlying disease for which the subject underwent allogeneic HCT (HCT cohort) was lymphoma, biopsy confirmation of relapsed EBV+ PTLD is required.
    6. Males and females of any age.
    7. Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged > 16 years; Lansky score ≥ 20 for subjects from birth to 16 years.
    8. For HCT cohort only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the subject underwent transplant must be in morphologic remission.
    9. Adequate organ function:
    a. Absolute neutrophil count ≥ 1000/μL (SOT cohort) or ≥ 500/μL (HCT cohort), with or without
    cytokine support
    b. Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For HCT cohort, platelet count < 50,000/μL but ≥ 20,000/μL, with or without transfusion support, is permissible if the subject has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute’s Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)
    c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI)
    each < 5 × the upper limit of normal (ULN); however, ALT, AST, and TBILI each ≤ 10 × ULN is
    acceptable if the elevation is considered by the investigator to be due to EBV and/or PTLD
    involvement of the liver as long as there is no known evidence of significant liver dysfunction (eg,
    elevated prothrombin time due to liver dysfunction, signs/symptoms of liver dysfunction such as
    asterixis, or similar).
    10. Subject or subject’s representative is willing and able to provide written informed consent.
    1. TOS previo de riñón, hígado, corazón, pulmón, páncreas, intestino delgado o cualquier combinación de estos (cohorte de TOS); o TCH alogénico previo (cohorte de TCH)
    2. Diagnóstico evaluado localmente y confirmado con biopsia de VEB+ ELP
    3. Disponibilidad de tabelecleucel parcialmente compatible y restringido para HLA confirmada por el promotor
    4. Enfermedad sistémica con avidez por 18fluorodeoxiglucosa (FDG) (puntuación de Deauville ≥3) medible por tomografía computarizada (TC) de diagnóstico/tomografía por emisión de positrones, excepto si está contraindicado o si lo exige la práctica local, en cuyo caso se pueden usar imágenes por resonancia magnética (RMN). Se utilizarán los criterios de respuesta de la clasificación de Luganoi. En el caso de sujetos con enfermedad del sistema nervioso central (SNC) tratada, será necesaria una TC de diagnóstico de la cabeza y/o una RMN del cerebro/columna vertebral, según sea apropiado desde el punto de vista clínico, para realizar un seguimiento de la respuesta de la enfermedad del SNC según los criterios de respuesta de la clasificación de Lugano.
    5. Fracaso del tratamiento con rituximab o monoterapia biosimilar intercambiable disponible en el mercado (subgrupo A de la cohorte de TOS o cohorte de TCH) o rituximab más cualquier tratamiento de quimioterapia administrado de forma concurrente o secuencial (subgrupo B de TOS) para el tratamiento de la ELP. El fracaso del tratamiento se define en función de la respuesta a rituximab de la siguiente manera:
    a. Progresión radiológica de la enfermedad según la clasificación de Lugano después de una dosis acumulativa mínima de 1125 mg/m2 de rituximab (por lo general, 3 dosis semanales de 375 mg/m2), o
    b. Incapacidad de lograr RC o RP, definida por los criterios radiológicos de Lugano, después de una dosis acumulativa mínima de 1500 mg/m2 de rituximab (por lo general, 4 dosis semanales de 375 mg/m2), o
    c. Recaída/progresión de la ELP después de una respuesta a rituximab (subgrupo A de la cohorte de TOS o cohorte de TCH) o rituximab más quimioterapia (subgrupo B de TOS), definida como evidencia radiológica y/o por biopsia de recaída/progresión coherente con la ELP. Si la enfermedad subyacente por la cual el sujeto se sometió al TCH alogénico (cohorte de TCH) era linfoma, se precisa confirmación por biopsia de recaída de VEB+ ELP
    6. Hombres y mujeres de cualquier edad
    7. Estado funcional del Eastern Cooperative Oncology Group ≤3 para sujetos mayores de 16 años; puntuación de Lansky ≥20 para sujetos desde el nacimiento hasta los 16 años.
    8. Solo para la cohorte de TCH: si se realizó un TCH alogénico como tratamiento para una neoplasia linfocítica o mieloide aguda, la enfermedad primaria subyacente por la cual el sujeto se sometió a un trasplante debe estar en remisión morfológica
    9. Funcionamiento adecuado de los órganos
    a. Recuento absoluto de neutrófilos ≥1000/μL (cohorte de TOS) o ≥500/μL (cohorte de TCH), con o sin apoyo de citocinas
    b. Recuento de plaquetas ≥50 000/μL, con o sin transfusión o apoyo de citocinas. Para la cohorte de TCH, se permite un recuento de plaquetas <50 000/μL pero ≥20 000/μL, con o sin apoyo de transfusiones, si el sujeto no ha tenido hemorragias de grado ≥2 en las 4 semanas anteriores (el grado de la hemorragia se determina según los criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute [CTCAE del NCI], versión 5.0)
    c. Alanina aminotransferasa (ALT), aspartato aminotransferasa (AST) y bilirrubina total (TBILI) <5 × el límite superior de la normalidad (LSN); sin embargo, se acepta ALT, AST y TBILI ≤10 × LSN cada uno si el investigador considera que la elevación se debe a la afectación del hígado por el VEB y/o la ELP, siempre y cuando no haya evidencia conocida de disfunción hepática significativa (p. ej., tiempo de protrombina elevado debido a disfunción hepática, signos o síntomas de disfunción hepática como asterixis o similar).
    10. El sujeto o el representante del sujeto está dispuesto y puede dar su consentimiento informado por escrito
    E.4Principal exclusion criteria
    1. Burkitt lymphoma, classical Hodgkin lymphoma, or any T-cell lymphoma.
    2. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or
    extracorporeal photopheresis.
    3. Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving CNS-directed
    chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Subjects with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.
    4. Suspected or confirmed grade ≥ 2 graft-versus-host disease per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system at enrollment.
    5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment.
    6. For HCT cohort only: Active adenovirus viremia.
    7. Need for vasopressor or ventilatory support.
    8. Antithymocyte globulin or similar anti-T-cell antibody therapy ≤ 4 weeks prior to enrollment.
    9. Treatment with EBV-CTLs or chimeric antigen receptor (CAR) T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts); or unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only).
    10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception.
    11. Inability to comply with study-related procedures
    1. Linfoma de Burkitt, linfoma de Hodgkin clásico o cualquier linfoma de linfocitos T
    2. Esteroides diarios de >0,5 mg/kg de prednisona o equivalente de glucocorticoides, metotrexato en curso o fotoféresis extracorpórea
    3. ELP del SNC no tratada o ELP del SNC para la cual el sujeto está recibiendo quimioterapia dirigida al SNC (sistémica o intratecal) o radioterapia en el momento de la inclusión. NOTA: Los sujetos con ELP del SNC previamente tratada pueden incluirse si se ha completado el tratamiento dirigido al SNC.
    4. Enfermedad de injerto contra huésped de grado ≥2 presunta o confirmada según el sistema de clasificación consensuada del Center for International Blood and Marrow Transplant Research (CIBMTR) en el momento de la inclusión
    5. Uso actual o reciente de un agente inhibidor del punto de control (p. ej., ipilimumab, pembrolizumab, nivolumab) dentro de las 3 semividas del fármaco desde la dosis más reciente hasta la inclusión
    6. Solo para la cohorte de TCH: viremia por adenovirus activa
    7. Necesidad de vasopresores o respiración asistida
    8. Globulina antitimocítica o tratamiento similar con anticuerpos anti-linfocitos T ≤4 semanas antes de la inclusión
    9. Tratamiento con LTC-VEB o linfocitos T con receptores de antígeno quimérico (CAR) dirigido contra linfocitos B en las 8 semanas previas a la inclusión (cohortes de TOS o TCH); o infusión de linfocitos del donante no seleccionados en las 8 semanas previas a la inclusión (solo cohorte de TCH)
    10. Mujeres en período de lactancia o embarazadas o mujeres en edad fértil o varones con una pareja en edad fértil que no desean utilizar un método anticonceptivo altamente eficaz
    11. Incapacidad de cumplir los procedimientos relacionados con el estudio
    E.5 End points
    E.5.1Primary end point(s)
    The ORR (CR or PR) obtained following administration of tabelecleucel with up to 2 different HLA
    restrictions in the SOT or HCT cohort
    La TRO (RC o RP) obtenida después de la administración de tabelecleucel con hasta 2 restricciones HLA diferentes en la cohorte de TOS o TCH
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Monitorizada a lo largo del estudio
    E.5.2Secondary end point(s)
    - DOR in SOT and HCT cohorts separately.
    - ORR and DOR in SOT and HCT cohorts combined.
    - Rates of CR and PR
    - Time to response and time to best response
    - OS
    - Rates of allograft loss/rejection episodes (for SOT cohort only): loss is defined as allograft removal, resumption of renal replacement therapy (kidney), initiation of a ventricular assist device (heart), need for mechanical ventilation or extracorporeal membrane oxygenation (lung), re-transplant (any), or placement on a SOT list (any); rejection episodes will be defined according to appropriate criteria for the particular organ transplant.
    - DdR en las cohortes de TOS y TCH por separado
    - TRO y DdR en las cohortes de TOS y TCH combinadas
    - Tasas de RC y RP
    - Tiempo hasta la respuesta y tiempo hasta la mejor respuesta
    - SG
    - Índices de episodios de pérdida/rechazo del aloinjerto (solo para la cohorte de TOS): la pérdida se define como la extracción del aloinjerto, la reanudación de la terapia de reemplazo renal (riñón), el inicio de un dispositivo de asistencia ventricular (corazón), la necesidad de ventilación mecánica u oxigenación extracorpórea de la membrana (pulmón), volver a someterse a trasplante (cualquiera) o inclusión en una lista de TOS (cualquiera). Los episodios de rechazo se definirán de acuerdo con los criterios apropiados para el trasplante de órgano en particular.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Monitorizada a lo largo del estudio
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Spain
    United Kingdom
    United States
    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
    After treatment is completed or discontinued, subjects will be assessed for disease response every 3 months, up to 24 months from cycle 1 day 1, and every 6 months thereafter up to 5 years from cycle 1 day 1 for survival status.
    Después de haber completado el tratamiento o de discontinuar, los pacientes serán evaluados para la respuesta a la enfermedad cada 3 meses, hasta 24 meses desde el ciclo 1 día 1, y cada 6 meses desde entonces hasta 5 años desde el ciclo 1 dia 1 para el estado de supervicencia.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years11
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 10
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 4
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 66
    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 Decision2020-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 01:50:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA