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    Summary
    EudraCT Number:2017-002023-21
    Sponsor's Protocol Code Number:GO39942
    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:2018-02-02
    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 number2017-002023-21
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL COMPARING THE EFFICACY AND SAFETY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB AND CHP (R-CHP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA
    ESTUDIO DE FASE III, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO PARA COMPARAR LA EFICACIA Y SEGURIDAD DE POLATUZUMAB VEDOTIN EN COMBINACIÓN CON RITUXIMAB Y CHP (R-CHP) EN COMPARACIÓN CON RITUXIMAB Y CHOP (R-CHOP) EN PACIENTES CON LINFOMA DIFUSO DE CÉLULAS GRANDES TIPO B NO TRATADO ANTERIORMENTE
    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 Polatuzumab Vedotin in Combination with Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients with Diffuse Large B-Cell Lymphoma
    Un estudio para evaluar la eficacia y seguridad de Polatuzumab Vedotin en combinación con Rituximab y CHP (R-CHP) versus Rituximab y CHOP (R-CHOP) en pacientes no tratados previamente con linfoma difuso de células B grandes
    A.4.1Sponsor's protocol code numberGO39942
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.6E-mailspain.start_up_unit@roche.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 namepolatuzumab vedotin
    D.3.2Product code RO5541077
    D.3.4Pharmaceutical form Powder for concentrate for solution for 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 INNPOLATUZUMAB VEDOTIN
    D.3.9.2Current sponsor codeRO5541077
    D.3.9.3Other descriptive nameDCDS4501A
    D.3.9.4EV Substance CodeSUB177827
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 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 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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for solution for 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 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 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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Vincristine Sulfate-TEVA
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Solution 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 INNVincristine sulfate
    D.3.9.3Other descriptive nameVINCRISTINE SULFATE
    D.3.9.4EV Substance CodeSUB05101MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for concentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diffuse large B-cell lymphoma (DLBCL)
    Linfoma difuso de células B grandes (DLBCL)
    E.1.1.1Medical condition in easily understood language
    DLBCL is the most common type of non-Hodgkin lymphoma, and is marked by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs
    El DLBCL es el tipo más común de linfoma no Hodgkin y está marcado por tumores de crecimiento rápido en los ganglios linfáticos, el bazo, el hígado, la médula ósea u otros órganos
    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 10012855
    E.1.2Term Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)
    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 efficacy of polatuzumab vedotin plus rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) compared with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) with respect to progression-free survival (PFS)
    -Evaluar la eficacia de polatuzumab vedotin más rituximab más ciclofosfamida, doxorrubicina y prednisona (R-CHP) en comparación con rituximab más ciclofosfamida, doxorrubicina, vincristina y prednisona (R-CHOP) con respecto a la supervivencia libre de progresión (SLP)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of polatuzumab vedotin plus R-CHP compared with R-CHOP with respect to secondary efficacy endpoints
    • To evaluate the safety of polatuzumab vedotin plus R-CHP compared with R-CHOP
    • To characterize the pharmacokinetics of polatuzumab vedotin
    • To evaluate the immune response to polatuzumab vedotin
    -Evaluar la eficacia de polatuzumab vedotin más R-CHP en comparación con R-CHOP con respecto a los puntos finales secundarios de eficacia
    • Para evaluar la seguridad de polatuzumab vedotin plus R-CHP en comparación con R-CHOP
    • Caracterizar la farmacocinética de polatuzumab vedotin
    • Evaluar la respuesta inmune al polatuzumab vedotin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-80 years
    - Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms:
    o DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type
    o T-cell/histiocyte-rich large B-cell lymphoma
    o Epstein-Barr virus-positive DLBCL, NOS
    o ALK-positive large B-cell lymphoma
    o HHV8-positive DLBCL, NOS
    o High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma)
    o High-grade B-cell lymphoma, NOS
    - Availability of archival or freshly collected tumor tissue before study enrollment
    - International Prognostic Index score of 2-5
    - Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
    - Life expectancy >= 12 months
    - At least one bi-dimensionally measurable lesion, defined as >= 1.5 cm in its longest dimension as measured by computed tomography or magnetic resonance imaging
    - Ability and willingness to comply with the study protocol procedures, including patient reported outcome measures
    - Left ventricular ejection fraction >= 50% on cardiac multiple-gated acquisition scan or cardiac echocardiogram
    - Adequate hematologic function
    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 12 months after the last dose of study treatment
    - For women of childbearing potential, a negative serum pregnancy test result within 7 days prior to commencement of dosing
    - For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm for at least 5 months after the last dose of blinded polatuzumab vedotin/placebo, 3 months after the last dose of rituximab, and for at least 6 months after the last dose of blinded vincristine/placebo and cyclophosphamide to avoid exposing the embryo for the duration of the pregnancy
    - Edad 18-80 años
    - Pacientes sin tto previo con DLBCL CD20-positivo, incluido uno de los siguientes diagnósticos seg la clasificación de la OMS de neoplasmas linfoides en 2016: DLBCL, no especificado de otra manera (NOS) incluyendo el tipo de células B del centro germinal,activadas o linfoma de células B grandes de células T / histiocitos o DLBCL positivo al virus de Epstein-Barr, NOS
    o linfoma de células B grandes ALK positivo o DLBCL positivo para HHV8, NOS
    o Linfoma de células B de alto grado con MYC y BCL2 y / o BCL6 (linfoma de doble golpe o triple golpe)o Linfoma de células B de alto grado, NOS
    - Dispde tejido tumoral archivado o recién recolectado antes de la inscripción en el estudio
    - Puntaje del Índice de Pronósticos Internacionales de 2-5
    - E C Oncology Group Estado de funci de 0, 1 o 2
    - Esperanza de vida> = 12 meses
    - Al menos una lesión bidimensional medible, definida como> = 1,5 cm en su dimensión más larga medida por tomografía comp o resonancia
    - Cap y disposición para cumplir con los proc del protocolo incluidas medidas de resultado informadas por los ptes
    - Fracde eyección del ventrículo izquierdo> = 50% en la adq cardíaca de adq múltiple o ecocardiograma cardíaco
    - Función hem adecuada
    - Para mujeres en edad fértil: acuerdo de permanecer abstinentes o métodos anticonceptivos con tasa de fracaso <1% por año durante el período de tto y durante al menos 12 meses desp última dosis del tto
    - Para las mujeres en edad fértil, un resultado de prueba de embarazo en suero negativo dentro de los 7 días preval inicio de la dosificación
    - Para hombres: acuerdo de permanecer abstinentes o usar condón y abstenerse de donar esperma durante al menos 5 meses después de la últ dosis de polatuzumab vedotin / placebo ciego, 3 meses después de la últ dosis de ritu, y durante al menos 6 meses después de la última dosis de vincristina / placebo y ciclofosfamida enmascarados para evitar la exposición del embrión durante la duración del embarazo
    E.4Principal exclusion criteria
    - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
    - Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
    - Prior organ transplantation
    - Current Grade >1 peripheral neuropathy by clinical examination
    - Demyelinating form of Charcot-Marie-Tooth disease
    - History of indolent lymphoma
    - Follicular lymphoma grade 3B
    - B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma)
    - Primary mediastinal (thymic) large B-cell lymphoma
    - Burkitt lymphoma
    - Prior treatment with cytotoxic drugs within 5 years of screening for any condition or prior use of any anti-CD20 antibody
    - Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
    - Prior therapy for DLBCL, with the exception of nodal biopsy
    - Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
    - Patients with CNS lymphoma, primary effusion DLBCL, and primary cutaneous DLBCL
    - Vaccination with live vaccines and any investigational therapy within 28 days prior to the start of Cycle 1
    - History of other malignancy that could affect compliance with the protocol or interpretation of results
    - Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease
    - Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
    - History or presence of an abnormal electrocardiogram that is clinically significant in the investigator’s opinion
    - Known active bacterial, viral, fungal, mycobacterial, parasitic or other infection at study enrollment or significant infections within 2 weeks before the start of Cycle 1
    - Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
    - Prior radiotherapy to the mediastinal/pericardial region
    - Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator’s judgment
    - Any of the abnormal laboratory values such as international normalization ratio > 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation, Partial thromboplastin time or activated partial thromboplastin time > 1.5 x ULN in the absence of a lupus anticoagulant, Serum aspartate aminotransferase and alanine aminotransferase >= 2.5 x ULN, Total bilirubin >= 1.5 x ULN, Serum creatinine clearance < 40 mL/min
    - Patients with suspected active or latent tuberculosis
    - Positive test results for chronic hepatitis B infection, hepatitis C, human T-lymphotrophic 1 virus
    - Known history of HIV seropositive status
    - Patients with a history of progressive multifocal leukoencephalopathy
    - Pregnancy or lactation or intending to become pregnant during study
    - Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to Cycle 1, Day 1
    -Antecedentes de reacciones alérgicas o anafilácticas graves a anticuerpos monoclonales humanizados o murinos o sensibilidad o alergia conocidas a los productos murinos
    -Contraindicación para cualquiera de los componentes individuales de CHOP, incluida la recepción anterior de antraciclinas
    -Trasplante de órganos anterior
    -Neuropatía periférica actual de grado 1 según la exploración clínica
    -Forma desmielinizante de la enfermedad de Charcot-Marie-Tooth
    - Antecedentes de linfoma de escasa malignidad
    -Linfoma de linfocitos B, no clasificable, con características intermedias entre el LDCGB y el linfoma de Hodgkin (linfoma de la zona gris)
    -Linfoma folicular de grado 3B
    -Linfoma de Burkitt
    -Tratamiento anterior con citotóxicos dentro de los 5 años anteriores al cribado de cualquier enfermedad o uso anterior de cualquier anticuerpo anti-CD20
    -Uso anterior de cualquier anticuerpo monoclonal durante los 3 meses anteriores al inicio del ciclo 1
    -Tratamiento anterior para LDCGB, a excepción de la biopsia ganglionar
    -Uso de corticosteroides 30 mg/día de prednisona o equivalente, con fines distintos del control de los síntomas del linfoma
    -Los pacientes con linfoma del SNC (afectación primaria o secundaria), LDCGB con derrame primario y LDCGB cutáneo primario
    -Vacunación con vacunas con microbios vivos en los 28 días previos al inicio del ciclo 1
    -Antecedentes de otra neoplasia maligna que pudiera afectar el cumplimiento del protocolo o la interpretación de los resultados
    -Signos de enfermedades significativas, no controladas, concomitantes que puedan afectar al cumplimiento del protocolo o la interpretación de los resultados, entre ellas, enfermedad cardiovascular significativa
    -Cirugía mayor reciente (en las 4 semanas anteriores al inicio del ciclo 1), para fines que no fueran de diagnóstico
    -Antecedentes o presencia de un ECG anómalo que es clínicamente significativo, en opinión del investigador
    -Infección bacteriana, vírica, fúngica, micobacteriana, parasitaria o de otro tipo activa diagnosticada,en el momento de la inscripción en el estudio o infecciones significativas en el lapso de las 2 semanas anteriores al inicio del ciclo 1
    -Hepatopatía clínicamente importante, como hepatitis vírica o de otro tipo activa, alcoholismo actual o cirrosis
    -Radioterapia anterior en la región del mediastino o pericardio
    -Consumo excesivo de drogas ilícitas o alcoholismo en los 12 meses anteriores a la selección, según el criterio del investigador
    -Cualquiera de las siguientes alteraciones en los valores analíticos (salvo que alguna de estas alteraciones se deban al linfoma de base):
    INR  1,5  del límite superior de la normalidad (LSN) en ausencia de anticoagulación terapéutica
    TTP o TTPa  1,5  LSN en ausencia de un anticoagulante lúpico
    AST y ALT en suero  2,5  LSN
    Bilirrubina total  1,5  LSN
    Los pacientes con diagnóstico confirmado de enfermedad de Gilbert pueden ser inscritos si la bilirrubina total es  3,0  LSN.Aclaramiento de creatinina sérica 40 ml/min
    -Los pacientes con sospecha de tuberculosis latente o activa
    -Resultados positivos en la prueba de infección por hepatitis B crónica,hepatitis C,Resultados positivos para el virus linfotrópico humano de células T tipo 1
    -Antecedentes conocidos de estado de seropositividad al VIH
    -Pacientes con antecedentes de leucoencefalopatía multifocal progresiva
    Embarazo, lactancia o que tengan la intención de quedarse embarazadas durante el estudio
    -Las mujeres con capacidad de procrear deben presentar una prueba de embarazo en suero negativa dentro de los 7 días anteriores al ciclo 1, día 1.
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression-free survival as assessed by the investigator by using the Lugano Response Criteria for Malignant Lymphoma
    1. La supervivencia libre de progresión evaluada por el investigador mediante el uso de los criterios de respuesta de Lugano para el linfoma maligno
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 65 months
    1. Hasta aproximadamente 65 meses
    E.5.2Secondary end point(s)
    1. 2-year progression-free survival rate as determined by the investigator
    2. Event-free survival (efficacy) as determined by the investigator
    3. Complete response rate at end of treatment by fluorodeoxyglucose positron emission tomography as determined by blinded independent central review and by the investigator
    4. Overall Survival
    5. Disease-free survival
    6. Duration of response
    7. Event-free survival (all causes)
    8. Time to deterioration in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 questionnaire (EORTC QLQ-C30) physical functioning and fatigue and Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)
    9. Proportion of patients achieving meaningful improvement in EORTC QLQ-C30 physical functioning and fatigue, and FACT-Lym LymS
    10. EORTC QLQ-C30 rate of treatment-related symptoms and FACT/ Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity peripheral neuropathy rate
    11. Incidence, nature, and severity of adverse events, with severity determined through use of
    National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)
    12. Incidence of peripheral neuropathy rates and severity determined through use of NCI CTCAE v4.0
    13. Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to adverse events
    14. Dose intensities of study drugs
    15. Plasma and/or serum concentration of polatuzumab vedotin related analytes at specified time points
    16. Incidence of Anti-drug antibodies (ADAs) to polatuzumab vedotin during the study relative to the prevalence of ADAs to polatuzumab vedotin at baseline
    1. Tasa de supervivencia libre de progresión de 2 años según lo determinado por el investigador
    2. Supervivencia libre de eventos (eficacia) según lo determine el investigador
    3. Tasa de respuesta completa al final del tratamiento mediante tomografía por emisión de positrones con fluorodesoxiglucosa según lo determinado por la revisión central independiente ciega y por el investigador
    4. Supervivencia global
    5. Supervivencia libre de enfermedad
    6. Duración de la respuesta
    7. Supervivencia libre de eventos (todas las causas)
    8. Tiempo de deterioro en la Organización Europea para la Investigación y el Tratamiento del Cáncer Calidad de Vida-cuestionario Core 30 (EORTC QLQ-C30) funcionamiento físico y fatiga y evaluación funcional de la terapia del cáncer-Linfoma Linfoma subescalar (FACT-Lym Lyms)
    9. Proporción de pacientes que lograron una mejora significativa en el funcionamiento físico y la fatiga de EORTC QLQ-C30 y FACT-Lym Lyms.
    10. EORTC QLQ-C30 tasa de síntomas relacionados con el tratamiento y FACT / Evaluación funcional de la terapia del cáncer / grupo de oncología ginecológica - Neurotoxicidad tasa de neuropatía periférica
    11. Incidencia, naturaleza y gravedad de los eventos adversos, con severidad determinada mediante el uso de
    Criterios de terminología común del Instituto Nacional del Cáncer para eventos adversos, versión 4.0 (NCI CTCAE v4.0)
    12. Incidencia de las tasas de neuropatía periférica y la gravedad determinada mediante el uso de NCI CTCAE v4.0
    13. Incidencia y naturaleza de la interrupción del medicamento en estudio, la reducción de la dosis y la demora de la dosis debido a eventos adversos
    14. Intensidades de dosis de la medicación del estudio
    15. Concentración plasmática y / o sérica de analitos relacionados con polatuzumab vedotin en momentos específicos
    16. Incidencia de anticuerpos antidrogas (ADA) para polatuzumab vedotin durante el estudio relativo a la prevalencia de ADA a polatuzumab vedotin al inicio del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At 24 months
    2-7. Up to approximately 65 months
    8-10. Day 1 of Cycle 1, 2, 3 and 5, at treatment completion, and post-treatment visits
    11-14. Up to approximately 65 months
    15-16. Day 1 of Cycle 1 and 4, at treatment completion and at 3 month post treatment follow-up visit
    1. A los 24 meses
    2-7. Hasta aproximadamente 65 meses
    8-10. Día 1 del ciclo 1, 2, 3 y 5, al finalizar el tratamiento y visitas posteriores al tratamiento
    11-14. Hasta aproximadamente 65 meses
    15-16. Día 1 del ciclo 1 y 4, al finalizar el tratamiento y a los 3 meses de la visita de seguimiento posterior al tratamiento
    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 Yes
    E.6.13.1Other scope of the trial description
    Patient reported outcomes
    Resultados informados por el paciente
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    polatuzumab vedotin + R-CHP + vincristine placebo versus polatuzumab vedotin placebo + R-CHOP
    E.8.2.4Number of treatment arms in the trial2
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA137
    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
    Brazil
    Canada
    China
    Czech Republic
    France
    Germany
    Hong Kong
    Israel
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Poland
    Portugal
    Russian Federation
    Spain
    Switzerland
    Taiwan
    Turkey
    Ukraine
    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
    LPLV
    La última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 525
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 463
    F.4.2.2In the whole clinical trial 875
    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)
    The Sponsor does not have any plans to provide Sponsor study drugs (polatuzumab vedotin, vincristine, or rituximab) or any other study treatments or interventions to patients who have completed the study. The Sponsor may evaluate
    whether to continue providing polatuzumab vedotin or rituximab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product available at the Roche Policy Web site
    El Sponsor no tiene previsto proporcionar medicamentos del estudio del Sponsor(polatuzumab vedotin, vincristine o rituximab) ni ningún otro tratamiento o intervención del estudio a pacientes que hayan completado el estudio. El patrocinador puede evaluarsi continuar proporcionando polatuzumab vedotin o rituximab de acuerdo con la Política global de Roche sobre el acceso continuo a los medicamentos de investigación disponible en el sitio web de la política de Roche
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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