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    Summary
    EudraCT Number:2019-004081-18
    Sponsor's Protocol Code Number:JCAR017-FOL-001
    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:2020-03-06
    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 number2019-004081-18
    A.3Full title of the trial
    A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL) (Transcend FL)
    Estudio en fase II, sin enmascaramiento, multicéntrico, de cohortes múltiples y de un solo grupo para evaluar la eficacia y la seguridad del JCAR017 en sujetos adultos con linfoma no hodgkiniano (LNH) de linfocitos B de escasa malignidad recidivante o resistente al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of JCAR017 in adult subjects with a type of cancer that affects B-cells, a type of white blood cell.
    Un estudio para evaluar la seguridad y eficacia de JCAR017 en sujetos adultos con un tipo de cancer que afecta los linfocitos B, un tipo de celulas de la sangre.
    A.4.1Sponsor's protocol code numberJCAR017-FOL-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04245839
    A.5.4Other Identifiers
    Name:WHO Universal Trial Number (UTN)Number:U1111-1244-9768
    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 Address86 Morris Avenue
    B.5.3.2Town/ citySummit, New Jersey
    B.5.3.3Post code07901
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 913-709-6862
    B.5.5Fax number+1 908-897-4074
    B.5.6E-mailClinicalTrialDisclosure@celgene.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/3/17/1890, EU/3/18/2018, EU/3/18/2099
    D.3 Description of the IMP
    D.3.1Product nameJCAR017
    D.3.2Product code JCAR017
    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 INNLISOCABTAGENE MARALEUCEL
    D.3.9.2Current sponsor codeJCAR017
    D.3.9.4EV Substance CodeSUB191306
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma (NHL)
    linfoma no hodgkiniano (LNH) de linfocitos B de escasa malignidad recidivante o resistente
    E.1.1.1Medical condition in easily understood language
    A cancer of B-cells, a type of white blood cell responsible for producing antibodies
    Un cáncer de células B, un tipo de glóbulo blanco responsable de producir anticuerpos.
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10016895
    E.1.2Term Follicle centre lymphomas diffuse predominantly small cell
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10076596
    E.1.2Term Marginal zone lymphoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10029460
    E.1.2Term Nodal marginal zone 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
    The primary objective of the study is to evaluate the efficacy of JCAR017 in subjects with relapsed/refractory (r/r) follicular lymphoma (FL) and marginal zone lymphoma (MZL)
    El objetivo principal del estudio es evaluar la eficacia del JCAR017 en sujetos con linfoma folicular (LF) y linfoma de zona marginal (LZM) recidivante o resistente al tratamiento (r/r).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:

    -To evaluate other measures of efficacy
    -To evaluate the safety of JCAR017
    -To characterize the pharmacokinetic (PK) profile of JCAR017
    -To evaluate the Health-Related-Quality of Life (HRQoL) using preselected primary domains of interest in the EORTC QLQ-C30 (global health/QoL, physical functioning, fatigue, pain) and FACT-LymS (lymphoma specific symptoms)
    Los objetivos secundarios son:
    -la evaluación de otras medidas de la eficacia
    -la evaluación de la seguridad del JCAR017
    -la caracterización del perfil farmacocinético (FC) del JCAR017
    -la evaluación de la calidad de vida relacionada con la salud (CdVRS) mediante los principales ámbitos de interés preseleccionados en el cuestionario sobre Calidad de vida C30 de la Organización europea para la investigación y el tratamiento del cáncer (EORTC QLQ-C30 —del ingl. European Organization of Research and Treatment of Cancer) y la Evaluación funcional del tratamiento antineoplásico, Subescala de linfoma (FACT-LymS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has FL (Grade 1, 2, or 3a) or MZL histologically confirmed within 6 months of screening, as assessed by local pathology.
    2. Subject must have relapsed or refractory disease, as assessed by the investigator.
    3. Subject must have measurable disease as follows:
    a. For FL subjects (Cohorts 1, 2, and 3), PET-positive disease with at least one PET-positive lesion and at least one measurable nodal or extranodal lesion greater than 1.5 cm in the long axis (refer to protocol, Appendix F)
    b. MZL subjects (Cohort 4) with PET non-avid disease should have at least one measurable nodal lesion greater than 2.0 cm in the long axis (PET-positive disease is not required for MZL) - refer to protocol, Appendix F
    4. Subject must have received the following, depending on cohort assignment:
    a. Cohort 1 (4L+ r/r FL): received at least 3 prior lines of systemic therapy. At least one of these lines must be a combination which included an anti-CD20 antibody (eg, rituximab, obinutuzumab) and an alkylating agent. Prior HSCT is permitted as a prior line of therapy. A group of 4L+ double-refractory subjects will be enrolled in this cohort (refer to protocol section 4.2).
    b. Cohort 2 (3L r/r FL): received 2 prior lines of systemic therapy. At least one of these lines must be a combination which included an anti-CD20 antibody (eg, rituximab, obinutuzumab) and an alkylating agent. In addition to this requirement, subjects must meet one of the following high-risk criteria: have relapsed or refractory disease within 12 months of completion of a prior line of therapy and have received prior combination therapies, OR relapsed after HSCT, OR meet the definition of double refractory (refer to protocol section 4.2)
    c. Cohort 3 (2L r/r FL): received 1 prior line of combination systemic therapy, which included an anti-CD20 antibody (eg, rituximab, obinutuzumab) and an alkylating agent. A group of POD24 subjects, defined as having progressive disease within 24 months of diagnosis and have received treatment within 6 months of the original FL diagnosis, will be enrolled to this cohort. The 2L subjects that do not meet this POD24 definition must instead meet one of the modified GELF criteria (NCCN, 2019) as outlined in protocol section 4.2, number 5.
    d.Cohort 4 (3L+ MZL): received at least 2 prior systemic therapies, including at least one line of combination systemic therapy, therapy with an anti-CD20 antibody (eg, rituximab, obinutuzumab) and an alkylating agent, or relapsed after HSCT. Splenectomy for Splenic MZL (SMZL) is considered as a line of therapy. Antibiotics for extranodal MZL (ENMZL) are not considered as a prior line of therapy.
    5. Subject is ≥ 18 years of age the time of signing the informed consent form (ICF).
    6. Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
    7. Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    8. Subject has adequate organ function.
    9. Subject has adequate vascular access for leukapheresis procedure.
    10. Subjects must agree to not donate blood, organs, sperm or semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy.
    11. Females of childbearing potential (FCBP) subjects must:
    a. Have 2 negative pregnancy tests as verified by the Investigator (one negative serum beta-human chorionic gonadotropin [ß-hCG] pregnancy test result at screening, and within 7 days prior to the first dose of lymphodepleting chemotherapy).
    b. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption.
    c. Agree to abstain from breastfeeding during study participation and for at least 12 months following lymphodepleting chemotherapy.
    12 Male subjects must:
    a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for 12 months after lymphodepleting chemotherapy even if he has undergone a successful vasectomy.
    1. El sujeto debe tener LF (grado 1, 2 o 3a) o LZM confirmado histológicamente en los 6 meses anteriores a la selección, determinado mediante una evaluación anatomopatológica local. 2. El sujeto debe tener enfermedad recidivante o resistente al tratamiento, determinada por el investigador. 3. El sujeto debe tener enfermedad mensurable, de la forma siguiente: a. En el caso de los sujetos con LF (cohortes 1, 2 y 3), enfermedad confirmada mediante TEP con al menos una lesión detectada en la TEP y al menos una lesión ganglionar o extraganglionar de más de 1,5 cm en el eje longitudinal (véase el protocolo, apéndice F) b. Los sujetos con LZM (cohorte 4) sin avidez en la TEP deben tener al menos una lesión ganglionar mensurable de más de 2,0 cm en el eje longitudinal (en el caso del LZM no es necesario la confirmación de la enfermedad mediante TEP); véase el protocolo, apéndice F. 4. Dependiendo de la cohorte a la que se le asigne, el sujeto debe haber recibido lo siguiente: a. Cohorte 1 (4L+ LF r/r): un mínimo de 3 líneas de tratamiento sistémico previas. Al menos una de dichas líneas debe ser una combinación que incluya un anticuerpo anti CD20 (por ejemplo, rituximab, obinutuzumab) y un alquilante. Está permitido el TCPH como línea de tratamiento previa. En esta cohorte se incluirá a un grupo de sujetos en cuarta línea de tratamiento o más, doblemente resistentes al tratamiento (véase el apartado 4.2 del protocolo). b. Cohorte 2 (3L LF r/r): un mínimo de 2 líneas de tratamiento sistémico previas. Al menos una de dichas líneas debe ser una combinación que incluya un anticuerpo anti CD20 (por ejemplo, rituximab, obinutuzumab) y un alquilante. Además de este este requisito, los sujetos deben cumplir uno de los siguientes criterios de alto riesgo: presentar enfermedad recidivante o resistente al tratamiento en los 12 meses siguientes a la finalización de una línea de tratamiento previa y haber recibido anteriormente tratamientos combinados O haber recaído tras un TCPH O cumplir la definición de doblemente resistente al tratamiento (véase el apartado 4.2 del protocolo) c. Cohorte 3 (2L LF r/r): un mínimo de 1 línea de tratamiento sistémico combinado, compuesta por un anticuerpo anti-CD20 (por ejemplo, rituximab, obinutuzumab) y un alquilante. En esta cohorte se incluirá a un grupo de sujetos PE24, definidos como sujetos que presentan progresión de la enfermedad en los 24 meses siguientes al diagnóstico y que han recibido tratamiento en los 6 meses siguientes al diagnóstico del LF original. Los sujetos 2L que no cumplan dicha definición de PE24 deben cumplir en su lugar uno de los criterios del GELF modificados (NCCN, 2019), tal como se describe en el punto 5 del apartado 4.2 del protocolo. d. Cohorte 4 (3L+ LZM): un mínimo de 2 líneas de tratamiento sistémico previas que incluyan al menos una línea de tratamiento sistémico combinado, compuesta por un anticuerpo anti-CD20 (por ejemplo, rituximab, obinutuzumab) y un alquilante, o haber recaído tras un TCPH. La esplenectomía para el LZM esplénico (LZME) se considera una línea de tratamiento. Los antibióticos para el LZM extraganglionar (LZMEG) no se consideran una línea previa de tratamiento. 5. El sujeto debe tener 18 años o más en el momento de la firma del formulario de consentimiento informado (FCI). 6. Los sujetos que hayan recibido un tratamiento previo dirigido contra el CD19 deben tener un linfoma con presencia de CD19 confirmado mediante biopsia después de finalizar el tratamiento previo dirigido contra el CD19. 7. El sujeto debe tener un estado funcional de 0 o 1 en la escala del Eastern Cooperative Oncology Group (ECOG). 8. El sujeto debe tener un funcionamiento orgánico satisfactorio. 9. El sujeto debe tener un acceso vascular adecuado para el procedimiento de leucocitaféresis. 10. El sujeto debe aceptar no donar sangre, órganos, espermatozoides, semen u óvulos para su uso en otras personas durante un mínimo de 1 año tras la quimioterapia productora de linfopenia. 11. Las mujeres en edad fértil (MEF) deben: a. Haber obtenido un resultado negativo en dos pruebas de embarazo verificado por el investigador (un resultado negativo en la prueba de embarazo de la gonadotropina coriónica humana [β-hCG] en suero durante la selección, y en los 7 días anteriores a la primera dosis de quimioterapia productora de linfopenia). b. Comprometerse a una abstinencia real de relaciones sexuales heterosexuales (que deberá revisarse todos los meses y documentarse en los documentos fuente, o bien a aceptar usar métodos anticonceptivos eficaces de forma ininterrumpida y tener capacidad para hacerlo. c. Abstenerse de practicar la lactancia materna durante la participación en el estudio y durante un mínimo de 12 meses tras la quimioterapia productora de linfopenia. Revisar el criterio 12 en la versión inglesa.
    E.4Principal exclusion criteria
    1. Evidence of composite DLBCL and FL, or of transformed FL. Subjects with World Health Organization (WHO) sub-classification of duodenal-type FL
    2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study based on investigator’s judgement.
    3. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study based on investigator’s judgement.
    4. Any condition that confounds the ability to interpret data from the study based on investigator’s judgement.
    5. Central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study).
    6. History of another primary malignancy that has not been in remission for at least 2 years For specific exceptions, see protocol section 4.3
    7. Previous treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis.
    8. Prior CAR T-cell or other genetically-modified T-cell therapy.
    9. History of or active human immunodeficiency virus (HIV).
    10. Active hepatitis B or active hepatitis C.
    11. Uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment.
    12. Active autoimmune disease requiring immunosuppressive therapy.
    13. Presence of acute or chronic graft-versus-host disease (GVHD).
    14. History of specific cardiovascular conditions within the past 6 months prior to signing the ICF (see protocol section 4.3).
    15. History or presence of clinically relevant central nervous system (CNS) pathology not related to disease under study. (see protocol section 4.3)
    16. Subject is a pregnant or nursing (lactating) woman.
    17. Subject has an intolerance to dimethyl sulfoxide (DMSO) and/or dextran
    18. Progressive vascular tumor invasion, thrombosis, or embolism
    19. Venous thrombosis or embolism not managed on a stable regimen of anticoagulation
    20. Subject has received or undergone the following (See section 4.3 for additional details).
    a. Therapeutic doses of corticosteroids (defined as >20 mg/day prednisone or equivalent) within 7 days prior to unstimulated leukapheresis.
    b. Cytotoxic chemotherapeutic agents that are not considered lymphotoxic and intrathecal chemotherapy must be stopped > 7 days prior to unstimulated leukapheresis
    c. Experimental agents within 4 weeks prior to signing the ICF unless no response or PD is documented on the experimental therapy
    d. Ibrutinib, lenalidomide and PI3Ki within 3 half-lives prior to unstimulated leukapheresis
    e. Immunosuppressive therapies within 4 weeks prior to leukapheresis and JCAR017 infusion
    f. Donor lymphocyte infusion (DLI) within 6 weeks prior to JCAR017 infusion
    g. Radiation within 6 weeks of leukapheresis.
    h. Systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to JCAR017 infusion.
    1. Signos de LDCBG y LF (linfoma mixto) o de LF transformado. Sujetos con la subclasificación de LF de tipo duodenal de la Organización Mundial de la Salud (OMS).
    2. Cualquier problema de salud, anomalía analítica o trastorno psiquiátrico relevantes que impediría la participación del sujeto en el estudio, según el criterio del investigador.
    3. Cualquier problema de salud, incluidas las anomalías analíticas, que podría suponer un riesgo inaceptable para el sujeto en caso de participar en el estudio, según el criterio del investigador.
    4. Cualquier problema de salud que induzca a confusión en la capacidad para interpretar los datos del estudio, según el criterio del investigador.
    5. Afectación exclusivamente del sistema nervioso central (SNC) a causa de una neoplasia maligna (nota: se permite la participación en el estudio de sujetos con afectación del SNC secundaria).
    6. Antecedentes de otra neoplasia maligna primaria que no haya permanecido en remisión durante al menos 2 años. Para consultar las excepciones específicas, véase el apartado 4.3.
    7. Tratamiento previo con alemtuzumab en los 6 meses anteriores a la leucocitaféresis o tratamiento con fludarabina o cladribina en los 3 meses anteriores a la leucocitaféresis.
    8. Tratamiento previo con linfocitos T CAR u otro tratamiento con linfocitos T modificados genéticamente.
    9. Antecedentes o presencia del virus de la inmunodeficiencia humana (VIH).
    10. Hepatitis B o C activas.
    11. Infección sistémica fúngica, bacteriana, vírica o de otro tipo no controlada (incluida la tuberculosis), a pesar de haberse administrado un tratamiento con los antibióticos adecuados u otro tipo de tratamiento.
    12. Enfermedades autoinmunitarias activas que requieran tratamiento inmunodepresor.
    13. Presencia de enfermedad de injerto contra huésped (EICH) aguda o crónica.
    14. Antecedentes de enfermedades cardiovasculares específicas en los 6 meses anteriores a la firma del FCI (véase el apartado 4.3 del protocolo).
    15. Antecedentes o presencia de una afección clínicamente relevante del sistema nervioso central (SNC) que no guarde relación con la enfermedad estudiada (véase el apartado 4.3 del protocolo).
    16. Ser una mujer embarazada o en periodo de lactancia.
    17. Intolerancia al dimetilsulfóxido (DMSO) y/o al dextrano.
    18. Invasión tumoral vascular progresiva, trombosis o embolia.
    19. Trombosis venosa o embolia sin tratamiento con una pauta estable de anticoagulantes.
    20. Haber recibido o haberse sometido a lo siguiente (véase el apartado 4.3 para conocer más detalles).
    a. Dosis terapéuticas de corticoesteroides (definidas como >20 mg/día de prednisona o un equivalente) en los 7 días previos a la leucocitaféresis no estimulada.
    b. Los antineoplásicos citotóxicos que no se consideren linfotóxicos y la quimioterapia intratecal deben suspenderse >7 días antes de la leucocitaféresis no estimulada.
    c. Fármacos experimentales en las 4 semanas anteriores a la firma del FCI, a menos que se documente la ausencia de respuesta o la PE con el tratamiento experimental.
    d. Ibrutinib, lenalidomida y PI3Ki en las 3 semividas anteriores a la leucocitaféresis no estimulada.
    e. Tratamientos inmunodepresores en las 4 semanas anteriores a la leucocitaféresis y la infusión de JCAR017.
    f. Infusión de linfocitos de donante (ILD) en las 6 semanas anteriores a la infusión de JCAR017.
    g. Radiación en las 6 semanas anteriores a la leucocitaféresis.
    h. Fármacos inmunoestimuladores sistémicos en las 6 semanas o 5 semividas del fármaco (el periodo que sea más corto) anteriores a la infusión de JCAR017.
    E.5 End points
    E.5.1Primary end point(s)
    Complete response rate (CRR) as assessed by PET-CT (FL) or CT (MZL) using “The Lugano Classification”.
    Evaluación radiológica de la neoplasia por tomografía computarizada de calidad diagnóstica (TC) o resonancia magnética nuclear (RMN) (tórax, cuello, abdomen y pelvis), o por tomografía por emisión de positrones (TEP) según la Clasificación de Lugano
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 24 months
    Hasta 24 meses
    E.5.2Secondary end point(s)
    -Overall response rate (ORR) as assessed by PET-CT (FL) or CT (MZL) using “The Lugano Classification”.
    -Duration of response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using “The Lugano Classification”.
    -Duration of response (DOR) as assessed by PET-CT and/or CT using “The Lugano Classification”.
    -Progression-free survival (PFS) as assessed by PET-CT and/or CT using “The Lugano Classification”.
    -Overall Survival (OS)
    -Safety
    -Pharmacokinetics (PK)
    -Health-related quality of life (HRQoL)
    - Tasa de respuesta global (TRG) evaluada mediante PET-TC (LF) o TC (LZM) según la Clasificación de Lugano.
    - Duración de la respuesta (DR) si la mejor respuesta global (MRG) es la RC, evaluada mediante PET-TC y/o TC según la Clasificación de Lugano.
    - Duración de la respuesta (DR) evaluada mediante PET-TC y/o TC según la Clasificación de Lugano.
    - Supervivencia sin progresión (SSP) evaluada mediante PET-TC y/o TC según la Clasificación de Lugano.
    - Supervivencia global (SG)
    - Seguridad
    - Farmacocinética (FC)
    - Calidad de vida relacionada con la salud (CVRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 24 months for all secondary endpoints.
    Hasta 24 meses para todos los objetivos secundarios.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Potential predictive biomarkers
    Posibles biomarcadores predictivos
    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) 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.8.2.4Number of treatment arms in the trial1
    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 EEA14
    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
    Canada
    France
    Germany
    Italy
    Japan
    Spain
    Sweden
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, the date when the last subject enters the LTFU study, or the date of receipt of the last data point from the last subject that is required for primary, secondary, and/or exploratory analysis, as prespecified in the protocol, whichever is the later date.
    El final del ensayo se define como la fecha de la última visita del último sujeto para completar el seguimiento posterior al tratamiento, la fecha en que el último sujeto entra en el estudio LTFU o la fecha de recepción del último punto de datos del ultimos sujeto que se requiere para el análisis primario, secundario y / o exploratorio, según lo especificado previamente en el protocolo, cualquiera que sea la fecha posterior.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 150
    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)
    Because this protocol involves gene transfer, long-term follow-up for lentiviral vector safety, disease status, and survival will continue on this protocol until 24 months after last infusion of JCAR017, regardless of disease status, and rolled over to a separate LTFU protocol thereafter for up to 15 years after JCAR017 infusion.
    Debido a que este protocolo implica la transferencia de genes, el seguimiento a largo plazo para la seguridad del vector lentiviral, el estado de la enfermedad y la supervivencia continuará en este protocolo hasta 24 meses después de la última infusión de JCAR017, independientemente del estado de la enfermedad, y se transferirá a un protocolo LTFU separado a partir de entonces hasta 15 años después de la infusión de JCAR017
    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 Decision2020-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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