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    Summary
    EudraCT Number:2018-001127-40
    Sponsor's Protocol Code Number:GO40554
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2018-11-16
    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 number2018-001127-40
    A.3Full title of the trial
    A PHASE I/II TRIAL OF MOSUNETUZUMAB (BTCT4465A) AS CONSOLIDATION THERAPY IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA FOLLOWING FIRST-LINE IMMUNOCHEMOTHERAPY AND AS THERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA WHO ARE UNABLE TO TOLERATE FULL-DOSE CHEMOTHERAPY
    ENSAYO DE FASE I/II CON MOSUNETUZUMAB (BTCT4465A) COMO TRATAMIENTO DE CONSOLIDACIÓN EN PACIENTES CON LINFOMA DIFUSO DE LINFOCITOS B GRANDES TRAS INMUNOQUIMIOTERAPIA DE PRIMERA LÍNEA Y COMO TRATAMIENTO EN PACIENTES CON LINFOMA DIFUSO DE LINFOCITOS B GRANDES NO TRATADO ANTERIORMENTE Y QUE NO TOLERAN LA QUIMIOTERAPIA A DOSIS COMPLETA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients with Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Therapy in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma who are Unable to Tolerate Full-Dose Chemotherapy
    Estudio de Mosunetuzumab (BTCT4465A) como tratamiento de consolidación en pacientes con linfoma difuso de células B grandes después de una inmunoquimioterapia de primera línea y como tratamiento en pacientes con linfoma difuso de células B grandes sin tratamiento previo que no toleran la quimioterapia a dosis completa
    A.4.1Sponsor's protocol code numberGO40554
    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.5.6E-mailglobal.rochegenentechtrials@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 nameMosunetuzumab
    D.3.2Product code RO7030816/F02-01
    D.3.4Pharmaceutical form 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 INNMosunetuzumab
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeRO7030816
    D.3.9.3Other descriptive nameBTCT4465A, anti−CD20/CD3, anti−CD20/CD3 TDB antibody, KTWE4644 (anti−CD20 half−antibody), HTHR4765 (anti−CD3 half−antibody)
    D.3.9.4EV Substance CodeSUB189787
    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 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 Yes
    D.3.11.13.1Other medicinal product typeMosunetuzumab is a humanized bispecific antibody composed of an anti-CD20 half-antibody and an anti-CD3 half-antibody.
    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 RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH, Germany
    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.3.1Product nameTocilizumab
    D.3.2Product code RO4877533/F01-02
    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 INNTOCILIZUMAB
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeRO4877533
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against the soluble and membrane-bound interleukin 6 receptor (IL-6R).
    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
    B-cell non-Hodgkin lymphoma (NHL)
    Linfoma no hodgkiniano de linfocitos B (LNH)
    E.1.1.1Medical condition in easily understood language
    B cell NHL is a cancer that starts in cells called B-lymphocytes, which are part of the body's immune system
    El LNH de células B es un cáncer que comienza en las células llamadas linfocitos B, que son parte del sistema inmune del cuerpo
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cohort A
    • To make a preliminary assessment of the anti-tumor activity of mosunetuzumab in patients with best response of partial response (PR)following first-line therapy for Diffuse Large B-Cell Lymphoma (DLBCL)
    • To evaluate the safety, tolerability, and pharmacokinetics (PK) of mosunetuzumab in patients previously treated with first-line immunochemotherapy for DLBCL, including determination of the recommended dose for consolidation therapy
    Cohort B
    • To make a preliminary assessment of anti tumor activity of mosunetuzumab in patients unable to receive full dose, first-line immunochemotherapy
    • To evaluate the safety, tolerability, and PK of mosunetuzumab in patients with previously untreated DLBCL unable to tolerate immunochemotherapy
    Cohorte A
    -Hacer una evaluación preliminar de la actividad antitumoral de mosunetuzumab en pacientes cuya mejor respuesta es una RP tras el tratamiento de primera línea para el LDLBG.
    -Evaluar la seguridad, la tolerabilidad y la farmacocinética de mosunetuzumab en pacientes tratados previamente con inmunoquimioterapia de primera línea para el LDLBG, lo que incluye determinar la dosis recomendada para el tratamiento de consolidación.
    Cohorte B
    --Para realizar una evaluación preliminar de la actividad antitumoral del mosunetuzumab en pacientes que no pueden recibir la dosis completa, inmunoquimioterapia de primera línea
    -Evaluar la seguridad, tolerabilidad y farmacocinética de mosunetuzumab en pacientes con LDCBG sin tratamiento previo que no toleran la inmunoquimioterapia
    E.2.2Secondary objectives of the trial
    • To make a preliminary assessment of efficacy of mosunetuzumab using measures other than complete response rate
    • To assess the immune response to mosunetuzumab and the potential effect of mosunetuzumab anti-drug antibody incidence on relevant clinical outcomes
    • To characterize the PK of mosunetuzumab and the relationship between serum PK, safety, biomarkers, and efficacy
    -Hacer una evaluación preliminar de la eficacia de mosunetuzumab usando medidas distintas a la tasa de RC por PET-CT.
    • Evaluar la respuesta inmunitaria a mosunetuzumab y evaluar el efecto potencial de la incidencia de AAF contra mosunetuzumab sobre los resultados clínicos pertinentes.
    • Caracterizar el PK del mosunetuzumab y la relación entre la PK sérica, la seguridad, los biomarcadores y la eficacia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for All Cohorts
    -Age >= 18 years
    - At least one bi-dimensionally measurable nodal lesion
    - Life expectancy of at least 24 weeks
    - Adequate hematologic function
    - Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
    -Use of contraception as defined by the protocol
    Inclusion criteria specific to Cohort A
    - Histologically confirmed DLBCL according to WHO 2016 classification
    - One prior systemic chemotherapy containing regimen for DLBCL
    - Best response of PR to prior systemic chemotherapy
    - Age >= 18 years
    - Left ventricular ejection fraction (LVEF) defined by multiple-gated acquisition /echocardiogram scan within the institutional limits of normal
    -- Use of contraception as defined by the protocol
    Inclusion criteria specific to Cohort B
    - Previously untreated, histologically confirmed, DLBCL according to WHO 2016
    - - In the opinion of the investigator, unable to receive full-dose standard
    chemotherapy
    - Age greater than or equal 80 years or 60 to 79 years, as defined below:
    -The patient must have adequate end-organ function
    -For patients who are 60 to 79 years of age, at least one of the
    following:
    - Impairment in at least one activity of daily living or instrumental
    activity of daily living
    - Impairment in cardiac function, renal function, or liver function such
    that the patient is unable to tolerate full-dose immunochemotherapy,
    such as R-CHOP
    Criterios de inclusión para todas las cohortes
    -Edad>= 18 years
    -Al menos una lesión nodal medible bidimensionalmente
    -Esperanza de vida de al menos 24 semanas
    -Función hemática adecuada
    -Estado funcional de 0, 1 o 2 en la escala ECOG
    -Uso de anticonceptivos como lo define el protocolo.
    Criterios de inclusión específicos de la cohorte A
    L-DLBG confirmado mediante histología conforme a la clasificación de la OMS de 2016
    -Una quimioterapia sistémica previa que contenga un régimen para el LDLBG.
    -Mejor respuesta de RP a la quimioterapia sistémica
    -Edad ≥18 años
    -Fracción de eyección ventricular izquierda (FEVI) definida por ventriculografía isotópica (MUGA) / ecocardiograma (ECO) con los límites de la normalidad
    -Uso de anticonceptivos como lo define el protocolo
    -Criterios de inclusión específicos de la cohorte B
    -LDLBG no tratado previamente, confirmado mediante histología conforme a la clasificación de la OMS
    -En opinión del investigador, incapaz de recibir la dosis completa estándar quimioterapia
    -Edad mayor o igual a 80 años o 60 a 79 años, como se define a continuación:
    -El paciente debe tener una adecuada función del órgano terminal.
    -Para pacientes de 60 a 79 años de edad, al menos uno de los
    siguientes:
    - Deterioro en al menos una actividad de la vida diaria o instrumental.
    actividad de la vida diaria
    - Deterioro de la función cardíaca, la función renal o la función hepática, como que el paciente es incapaz de tolerar la dosis completa de inmunoquimioterapia, tales como R-CHOP
    E.4Principal exclusion criteria
    Exclusion Criteria for All Cohorts
    - Transformed lymphoma
    - Prior treatment with mosunetuzumab
    - Prior stem cell transplant (autologous and allogeneic)
    - Administration of a live, attenuated vaccine within 4 during a specified period
    - Prior solid organ transplantation
    - History of autoimmune disease
    - Received systemic immunosuppressive medications
    - Current or past history of central nervous system (CNS) disease
    - History of other malignancy
    - Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol
    - Known active bacterial, viral, fungal or other infection at study enrollment
    - Clinically significant history of liver disease
    - Recent major surgery within a specified period
    - Abnormal laboratory values
    - Prior treatment with radiotherapy
    - Adverse events from prior anti-cancer therapy not resolved to <= Grade 1
    - Significant cardiovascular disease or significant pulmonary disease
    Exclusion Criteria Specific to Cohort A
    - Prior treatment with chemotherapy, immunotherapy, or biologic therapy within a specified period
    - Pregnant or breastfeeding, or intending to become pregnant during the study
    Exclusion Criterion Specific to Cohort B
    - Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy
    Criterios de exclusión para todas las cohortes
    -Linfoma transformado.
    -Tratamiento previo con mosunetuzumab.
    -Trasplante de células madre previo (autólogo y alógeno).
    - Administración de una vacuna elaborada con microbios vivos atenuados en las 4 semanas previas durante un periodo especifico
    - Trasplante de órgano sólido previo-
    -Antecedentes de enfermedad autoinmunitaria
    -Administración de inmunosupresores sistémicos
    -Enfermedad del SNC actual o antecedentes de ella
    -Antecedentes de otra neoplasia maligna
    -Indicios de enfermedades significativas, concomitantes, no controladas, que pudieran afectar el cumplimiento del protocolo
    -Infección activa conocida, ya sea bacteriana, viral, fúngica, micobacteriana, parasitaria o de otro tipo en el enrollment del estudio
    -Antecedentes clínicamente significativo de hepatopatías
    -Cirugía mayor reciente durante un período específico
    -Cualquiera de los valores analíticos anómalos
    -Tratamiento previo con radioterapia
    -Acontecimientos adversos del tratamiento antineoplásico anterior no resueltos hasta un grado ≤1
    -Cardiovasculopatía significativa o enfermedad pulmonar importante
    Criterios de exclusión específicos de la cohorte A
    Tratamiento anterior con quimioterapia, inmunoterapia o terapia biológica dentro de un período especifico
    -Mujeres embarazadas o lactantes, o que pretenden quedarse embarazadas durante el estudio
    Criterios de exclusión específicos de la cohorte B
    -Tratamiento previo para el LDLBG con quimioterapia, inmunoterapia y terapia biológica
    E.5 End points
    E.5.1Primary end point(s)
    For Cohort A and B
    1. Positron emission tomography–computed tomography (PET-CT) complete response rate
    2. Incidence and severity of adverse events
    Para la cohorte A y B
    1. Tasa de respuesta completa de tomografía por emisión de positrones (PET-CT) de acuerdo con los criterios de respuesta de Lugano 2014 en la evaluación de la respuesta primaria según lo determine el investigador
    2. Incidencia y gravedad de los eventos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Up to 60 months
    1-2. Hasta 60 meses
    E.5.2Secondary end point(s)
    1. Objective response rate
    2. Duration of response
    3. Progression-free survival
    4. Event-free survival
    5. Incidence of Antidrug antibody (ADA) to mosunetuzumab
    6. Relationship between ADAs and PK, safety, efficacy, and biomarkers may be explored as appropriate
    7. Maximum serum concentration (Cmax) and minimum serum concentration (Cmin) of mosunetuzumab
    8. Total exposure (area under the concentration-time curve [AUC]) of mosunetuzumab
    9. Clearance of mosunetuzumab
    10. Volume of distribution of mosunetuzumab
    11. Relationship between serum pharmacokinetics and safety, biomarkers, or efficacy endpoints, as appropriate
    1. Tasa de respuesta objetiva
    2. Duración de la respuesta
    3. La supervivencia libre de progresión
    4. Supervivencia sin eventos
    5. Incidencia de anticuerpos antidrogas (ADA) en mosunetuzumab
    6. La relación entre ADA y PK, seguridad, eficacia y biomarcadores se puede explorar según corresponda
    7. Concentración sérica máxima (Cmax) y concentración sérica mínima (Cmin) de mosunetuzumab
    8. Exposición total (área bajo la curva de concentración-tiempo [AUC]) de mosunetuzumab
    9. Liquidación de mosunetuzumab
    10. Volumen de distribución de mosunetuzumab
    11. Relación entre la farmacocinética sérica y los marcadores de seguridad, biomarcadores o eficacia, según corresponda









    . Tasa de respuesta objetiva
    2. Duración de la respuesta
    3. La supervivencia libre de progresión
    4. Supervivencia sin eventos
    5. Incidencia de anticuerpos antidrogas (ADA) en mosunetuzumab
    6. La relación entre ADA y PK, seguridad, eficacia y biomarcadores se puede explorar según corresponda
    7. Concentración sérica máxima (Cmax) y concentración sérica mínima (Cmin) de mosunetuzumab
    8. Exposición total (área bajo la curva de concentración-tiempo [AUC]) de mosunetuzumab
    9. Liquidación de mosunetuzumab
    10. Volumen de distribución de mosunetuzumab
    11. Relación entre la farmacocinética sérica y los marcadores de seguridad, biomarcadores o eficacia, según corresponda











    Tasa de respuesta objetiva
    2. Duración de la respuesta
    3. La supervivencia libre de progresión
    4. Supervivencia sin eventos
    5. Incidencia de anticuerpos antidrogas (ADA) en mosunetuzumab
    6. La relación entre ADA y PK, seguridad, eficacia y biomarcadores se puede explorar según corresponda
    7. Concentración sérica máxima (Cmax) y concentración sérica mínima (Cmin) de mosunetuzumab
    8. Exposición total (área bajo la curva de concentración-tiempo [AUC]) de mosunetuzumab
    9. Liquidación de mosunetuzumab
    10. Volumen de distribución de mosunetuzumab
    11. Relación entre la farmacocinética sérica y los marcadores de seguridad, biomarcadores o eficacia, según corresponda
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Up to 60 months
    5-6. Up to 60 weeks
    7-11. Up to 60 weeks
    1-4. Hasta 60 meses
    5-6. Hasta 60 semanas
    7-11. Hasta 60 semanas
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, immunogenicity, PD biomarkers, prognostic biomarkers, ctDNA
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose-Finding
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Israel
    Poland
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of this study is defined as the date when the last patient, last visit occurs, including survival follow-up visits conducted by telephone or on-site visits.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 60
    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 will offer continued access to Roche IMPs (mosunetuzumab and tocilizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in protocol section 4.3.4.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-23
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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