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    Summary
    EudraCT Number:2016-003579-22
    Sponsor's Protocol Code Number:MO39107
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003579-22
    A.3Full title of the trial
    A PHASE II STUDY EXPLORING THE SAFETY AND EFFICACY OF ATEZOLIZUMAB ADMINISTERED IN COMBINATION WITH OBINUTUZUMAB OR RITUXIMAB ANTI-CD20 THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA, MARGINAL ZONE LYMPHOMA AND WALDENSTR¿M MACROGLOBULINEMIA
    STUDIO DI FASE II PER ANALIZZARE LA SICUREZZA E L¿EFFICACIA DI ATEZOLIZUMAB SOMMINISTRATO IN ASSOCIAZIONE CON OBINUTUZUMAB O RITUXIMAB (TERAPIA ANTI-CD20) IN PAZIENTI AFFETTI DA LINFOMA MANTELLARE, LINFOMA DELLA ZONA MARGINALE E MACROGLOBULINEMIA DI WALDENSTR¿M RECIDIVATI/REFRATTARI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Exploring the Safety and Efficacy of Atezolizumab Administered in Combination with Obinutuzumab or Rituximab Anti-CD20 Therapy in Patients with Relapsed/Refractory Mantle Cell Lymphoma, Marginal Zone Lymphoma and Waldenstr¿m Macroglobulinemia
    STUDIO PER ANALIZZARE LA SICUREZZA E L¿EFFICACIA DI ATEZOLIZUMAB SOMMINISTRATO IN ASSOCIAZIONE CON OBINUTUZUMAB O RITUXIMAB (TERAPIA ANTI-CD20) IN PAZIENTI AFFETTI DA LINFOMA MANTELLARE, LINFOMA DELLA ZONA MARGINALE E MACROGLOBULINEMIA DI WALDENSTR¿M RECIDIVATI/REFRATTARI
    A.3.2Name or abbreviated title of the trial where available
    A Study Exploring the Safety and Efficacy of Atezolizumab Administered in Combination with Obinutuzu
    STUDIO PER ANALIZZARE LA SICUREZZA E L¿EFFICACIA DI ATEZOLIZUMAB SOMMINISTRATO IN ASSOCIAZIONE CON O
    A.4.1Sponsor's protocol code numberMO39107
    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.Hoffman-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 number000000
    B.5.5Fax number000000
    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 nameAtezolizumab
    D.3.2Product code RO5541267
    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 INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameTECENTRIQ
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 GAZYVARO - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO - 1000MG/40ML - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION GmbH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 name-
    D.3.2Product code [-]
    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 INNObinutuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRO5072759
    D.3.9.3Other descriptive nameOBINUTUZUMAB
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 MABTHERA - 1 FIALA 500 MG 50 ML
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION GmbH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMabThera 500 mg concentrate for solution for infusion
    D.3.2Product code RO0452294
    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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRO452294
    D.3.9.3Other descriptive nameMabThera 500 mg concentrate for solution for infusion
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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 - 1400 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 15 ML (120MG/ML) - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION GmbH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMabThera 1400 mg solution for subcutaneous injection
    D.3.2Product code RO0452294
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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.3.9.2Current sponsor codeRO452294
    D.3.9.3Other descriptive nameMabThera 1400 mg solution for subcutaneous injection
    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 number120
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 5
    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 Tecentriq - codice AIC EU/1/17/1220/001
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 name-
    D.3.2Product code [-]
    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 INNAtezolizumab
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.4EV Substance CodeSUB18312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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/Refractory Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) and Waldenstr¿m Macroglobulinemia (WM)
    LINFOMA A CELLULE MANTELLARI, LINFOMA DELLA ZONA MARGINALE E MACROGLOBULINEMIA DI WALDENSTR¿M
    E.1.1.1Medical condition in easily understood language
    MCL is a B-cell non-Hodgkin lymphoma (lymph nodes, spleen, etc); MZL (B-cell lymphoma) arise from post-germinal center marginal zone B-cell; WM is a lymphoplasmacytic lymphoma in the bone marrow.
    MCL è un linf. non-Hodgkin di cell B (linfonodi, milza, ecc); MZL (Linf. a cell B) si sviluppano dalla zona marginale post-germinale della cellB;
    WM è un linfoma linfoplasmacytico nel midollo osseo.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10054698
    E.1.2Term Waldenstrom's macroglobulinemia refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10026800
    E.1.2Term Mantle cell lymphoma recurrent
    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 10026801
    E.1.2Term Mantle cell lymphoma refractory
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10077534
    E.1.2Term Marginal zone lymphoma refractory
    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 10077533
    E.1.2Term Marginal zone lymphoma recurrent
    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 LLT
    E.1.2Classification code 10054697
    E.1.2Term Waldenstrom's macroglobulinemia recurrent
    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 LLT
    E.1.2Classification code 10054697
    E.1.2Term Waldenstrom's macroglobulinemia recurrent
    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 LLT
    E.1.2Classification code 10054698
    E.1.2Term Waldenstrom's macroglobulinemia refractory
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10077534
    E.1.2Term Marginal zone lymphoma refractory
    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 10077533
    E.1.2Term Marginal zone lymphoma recurrent
    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 10026801
    E.1.2Term Mantle cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10026800
    E.1.2Term Mantle cell lymphoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 atezolizumab in combination with obinutuzumab or rituximab
    Valutare l¿efficacia di atezolizumab in associazione a obinutuzumab o rituximab.
    E.2.2Secondary objectives of the trial
    ¿ To evaluate the efficacy of atezolizumab in combination with obinutuzumab or rituximab
    ¿ To evaluate the safety and tolerability of atezolizumab in combination with obinutuzumab or rituximab
    ¿ To characterize the pharmacokinetics of atezolizumab and obinutuzumab when administered in combination in MCL and WM patients
    ¿ To characterize the pharmacokinetics of atezolizumab and rituximab when administered in combination in MZL patients
    ¿ To evaluate the immune response to atezolizumab with obinutuzumab or rituximab
    - Valutare l¿efficacia di atezolizumab in associazione a obinutuzumab o rituximab.
    -Valutare la sicurezza e la tollerabilit¿ di atezolizumab in associazione a obinutuzumab o rituximab.
    -Caratterizzare la farmacocinetica di atezolizumab e obinutuzumab quando somministrati in associazione in pazienti con LCM eMW.
    ¿ Caratterizzare la farmacocinetica di atezolizumab e rituximab quando somministrati in associazione in pazienti con LZM.
    - Valutare la risposta immunitaria ad atezolizumab associato a obinutuzumab o rituximab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Ability to comply with the protocol
    - Age >= 18 years
    - Histologically documented, CD20 positive non-Hodgkin lymphoma (NHL), relapsed or refractory MCL and MZL and WM. Refractory is definited for 3 indications as having relapsed during or within 6 months after the last dose of the previous tratment. For WM patients, the diagnosis of relapse/refractory will be accompanied by evidence of reappearance of monoclonal IgM protein and/or recurrence of bone marrow involvement,
    lymphadenopathy/splenomegaly with symptoms attributable to active disease. Where ibrutinib is avalilable in the selected contry, patients with MCL or WM must have relapsed or become refractory to its benefits, or become intolerant of ibrutinib. all other patients must have failed at least 1 prior line of systemic treatment.
    - Bone marrow biopsy and/or other sites of disease at screening for tumor staging and response evaluation
    - ECOG performance status of 0, 1 or 2
    - Life expectancy>=12 weeks
    - For mantle cell lymphoma (MCL) and nodal marginal zone lymphoma (MZL), at least one bi-dimensionally measurable lesion>=1.5 cm in its largest dimension by Computed Tomography scan or MRI, as defined by Revised Response Criteria for Malignant Lymphoma
    - Adequate hematologic and end-organ function
    - For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or to use single highly effective or combined contraceptive methods that result in a failure rate of < 1% per year starting at leasr 28 days prior to day 1 of ycle 1, during the treatment period and for at least 18 months after the last dose of combination therapy
    - For women of childbearing potential, a negative serum pregnancy test result within 3 days prior to Day 1 of Cycle 1 prior to dosing. In addition, a urine pregnancy test should be done prior to dosing on Day 1 of Cycle 1 to confirm the negative result if the serum test was not performed prior to dosing on D1 of C1. For all other women, documentation must be present in the medical history confirming that the patients is not of childbearing potential.
    - For men, agreement to remain abstinent or to use a condom plus an additional contraceptive method that together result in a failure rate of 1% per year during the treatment period and for at least 3 months after the last dose of combination therapy.
    - Tumor tissue fresh sample preferred, archival tissue is acceptable (only if a fresch sample is not available).
    -Capacità di rispettare il protocollo
    -Età = 18 anni
    -LCM, LZM e MW istologicamente documentati e CD20-positivo (valutato localmente), recidivati o refrattari. Per le 3 indicazioni, si definisce refrattaria una malattia recidivata durante il trattamento precedente o entro 6 mesi dall’ultima dose. Nel caso di pazienti con MW, la diagnosi di malattia recidivata/refrattaria sarà supportata dall'evidenza di ricomparsa di proteine IgM monoclonali e/o nuovo coinvolgimento midollare, linfoadenopatia/splenomegalia con sintomi attribuibili a una malattia attiva. Qualora ibrutinib fosse disponibile, pazienti con LCM e MW dovranno essere recidivati o diventati refrattari ai suoi benefici, o intolleranti ad ibrutininb.Tutti gli altri pazienti devono aver fallito almeno 1 precedente linea di terapia sistemica.
    -Biopsia del midollo osseo e/o di altre sedi di malattia allo screening per la stadiazione tumorale e la valutazione della risposta (se non eseguita nei 6 mesi precedenti lo screening).
    -Performance status ECOG di 0, 1 o 2
    -Aspettativa di vita = 12 settimane
    -Per LCM e LZM nodale, almeno una lesione misurabile bidimensionalmente con asse maggiore = 1,5 cm rilevata alla Tomografia computerizzata (TAC) o alla risonanza magnetica (RM, accettata soltanto nei pazienti con controindicazioni per la TAC), secondo la definizione dei criteri rivisti di valutazione della risposta per il linfoma maligno (Cheson 2007).
    -Adeguata funzionalità ematologica e degli organi terminali
    -Per le donne non in postmenopausa (< 12 mesi di amenorrea non indotta da terapia ed età < 45 anni) o chirurgicamente sterili (assenza di ovaie e/o utero): consenso a praticare l’astinenza o a utilizzare un singolo metodo contraccettivo altamente efficace o metodi combinati caratterizzati da un tasso di fallimento < 1% l’anno, iniziando almeno 28 giorni prima del Giorno 1 del ciclo1, durante il periodo di trattamento e per almeno 18 mesi dopo l’ultima dose della terapia di associazione.
    -Per le donne potenzialmente fertili (incluse donne in pre-menopausa sottoposte a legatura delle tube e donne che non incontrano la definizione di post-menopausa) è richiesto un test di gravidanza sul siero negativo o entro 3 giorni dal ciclo 1 giorno 1 prima della somministrazione del trattamento. In aggiunta, un test di gravidanza eseguito sulle urine dovrà essere effettuato prima del trattamento al ciclo 1 giorno 1 per confermare il risultato negativo qualora il test su siero non sia eseguito il giorno 1 ciclo 1 precedentemente l’inizio del trattamento. Per tutte le altre donne, nella storia medica deve essere documentata la conferma che la paziente non sia potenzialmente fertile.
    -Per gli uomini, consenso ad astenersi dai rapporti sessuali oppure a utilizzare il profilattico in associazione a un metodo contraccettivo supplementare, che insieme determinino un tasso di insuccesso dell’1% l’anno, durante il periodo di trattamento e per almeno 3 mesi dopo l’ultima dose della terapia di combinazione.
    -Tessuto tumorale (di preferenza fresco, un campione di archivio è accettato solo se il campione fresco non è disponibile)
    E.4Principal exclusion criteria
    - Any approved anticancer therapy or hormonal therapy within 3 weeks prior to initiation of study treatment. Any radiotherapy within 4 weeks prior to initiation of study treatment.
    - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days oe 5 half-lifes prior to enrolment, whichever is longest.
    - Known Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma
    - Uncontrolled tumor-related pain
    - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; patients with indwelling catheters are eligible
    - Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
    - History of other malignancy
    - History of severe allergic or anaphylactic or other hypersensitivity reactions to chimeric or humanized or murine monoclonal antibodies or fusion proteins or murine proteins or known sensitivity or allergy to murine products
    - Severe infection within 4 weeks prior to initiation of study treatment,
    including, but not limited to, hospitalization for complications of
    infection, bacteremia, or severe pneumonia
    - Regular treatment with corticosteroids within the 4 weeks prior to the start of C1
    General Medical Exclusions
    - Pregnant and lactating women, or intending to become pregnant during the study or within 18 months after the last dose of combination therapy. Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 3 days prior to D1 of C1 prior to dosing. In addition, a urine pregnancy test should be done prior to dosing on D1 of C1 to confirm the negative result if the serum test was not performed prior to dosing on D1 of C1
    - History of autoimmune disease
    - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
    - Significant cardiovascular disease, within 3 months prior to initiation of study treatment
    - Patients with history of confirmed progressive multifocal leukoencephalopathy
    - Patients with prior allogeneic bone marrow transplantation (allo BMT) allogeneic stem cell transplant (ASCT), or prior solid organ transplantation
    - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest CT scan at screening
    - Serum albumin < 2.5 g/dL
    - Positive test for HIV, human T-lymphotrophic 1 virus, and hepatitis B or C
    - Active tuberculosis
    - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
    - Major surgical procedure other than for diagnosis within 28 days prior to C1D1
    - Administration of a live, attenuated vaccine (e.g., FluMist®) within 4 weeks before C1D1
    Exclusion Criteria Related to Medications
    - Known Hypersensitivity to obinutuzumab, rituximab or atezolizumab or their formulation excipients
    - Prior treatment with obinutuzumab or atezolizumab, or anti progressive disease (PD)-1 or programmed death-ligand 1 (PDL-1) antibodies
    - Fludarabine or Campath® within 12 months prior to study entry
    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA4 anti–PD-1, and anti–PD-L1 therapeutic antibodies
    - Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is longer, prior to C1D1
    - Treatment with systemic immunosuppressive medications within 2 weeks prior to C1D1 or anticipation of need for systemic immunosuppressive medication during study treatment
    Qualsiasi terap. antineoplastica approvata o ormonale nelle 3 sett. precedenti l'inizio del tratt. Qualsiasi radioterapia nelle 4 sett precedenti l'inizio del tratt.-Tratt. con altro agente sperim. o partecipazione ad altro studio clin con intento terapeutico nei 28 gg o 5 emivite precedenti l’arruolamento, a seconda di quale sia più lungo-Noto linfoma del sistema nerv. centrale, linfoma leptomeningeo o evidenza istologica di trasformazione in un tumore ad elevato grado di malignità o linfoma diffuso a grandi cellule B-Dolore incontrollato correlato al tumore-Versamento pleurico non controllato, versam. pericardico o ascite con necessità di ricorrenti procedure di drenaggio; i paz. con catetere a permanenza sono eleggibili.-Ipercalcemia non controllata o ipercalcemia sintomatica che imponga l’uso continuativo di terap con bifosfonati o denosumab-Anamnesi di altre neoplasie maligne-Anamnesi di gravi reazioni allergiche o anafilattiche o altre reazioni di ipersensibilità agli anticorpi monoclonali chimerici o umanizzati o murini o proteine di fusione o proteine murine o nota sensibilità o allergia ai prodotti murini. -Infezioni severe nelle 4 sett precedenti il tratt, incluse, ma non limitate a, ricovero ospedaliero per complicazioni collegate all’infezione, batteriemia o grave polmonite-Tratt. regolare con corticosteroidi nelle 4 sett prec C1-Esclusioni mediche generiche:-Donne in gravidanza, allattamento o che pianificano una gravidanza durante lo studio o entro 18 mesi dall’ultima dose della terap di associazione. Le donne non in post-menopausa o chirurgicamente sterili devono presentare un risultato negativo del test di gravidanza eseguito entro 3 gg dal C1D1 prima della somministrazione del tratt.. In aggiunta, un test di gravidanza sulle urine dovrà essere effettuato prima del tratt al C1D1 per confermare il risultato negativo qualora il test su siero non sia eseguito-Anamnesi di malattia autoimmune-Altre patologie disfunzioni metaboliche, anormalità all’esame fisico o anormalità di lab che controindichino l'uso di un farmaco sperim, che possano influire sull'interpretazione dei risultati o possano rendere il paz ad alto rischio per complicazioni al tratt.-Malattia cardiovascolare significativa nei 3 mesi precedenti l’inizio del tratt-Paz con anamnesi di leucoencefalopatia multifocale progressiva confermata-Pazi precedentemente sottoposti a trapianto allogenico di midollo osseo, o allogenico di cellule staminali o di organi solidi-Anamnesi di fibrosi polmonare idiopatica, polmonite in organizzazione, polmonite indotta da farmaci, polmonite idiopatica o evidenza di polmonite attiva alla TAC toracica di screening.-Albumina sierica < 2,5 g/dl.-Positività al test per: HIV, virus T-linfotropico umano di tipo 1 , epatite B, epatite C-Tubercolosi attiva.-Tratt con antibiotici EV nelle 2 sett precedenti inizio del tratt. -Procedura chirurgica maggiore, se non a scopo diagnostico, nei 28 ggprecedenti il C1D1 o procedura chirurgica maggiore prevista durante lo studio.-Somministrazione di un vaccino vivo attenuato (per es. FluMist®) nelle 4 sett precedenti il C1D1 Criteri di esclusione correlati ai medicinali:-Ipersensibilità a obinutuzumab, rituximab o atezolizumab o agli eccipienti delle rispettive formulazioni.-Precedente tratt con obinutuzumab o atezolizumab, o con anticorpi diretti contro PD-1 o PDL-1.-Assunzione di fludarabina o Campath® nei 12 mesi precedenti l’ingresso in studio.-Precedente tratt con agonisti di CD137 o terapie bloccanti i checkpoint immunitari, compresi gli anticorpi terapeutici anti-CTLA4, anti-PD1, e anti PD-L1-Tratt con agenti immunostimolatori nelle 4 sett o 5 emivite del farmaco, dei due periodi il più lungo, precedenti il C1D1-Tratt con medicinali immunosoppressori sistemici, es cortisone, ciclofosfamide, azatioprina, metotressato, talidomide e agenti anti-fattore di necrosi tumorale nelle 2sett preced C1D1 o che si preveda la necessità di farmaci immunosoppressivi sistemici durante il tratt.
    E.5 End points
    E.5.1Primary end point(s)
    1. For MCL and nodal and extra-nodal MZL, objective response (OR) at end of Induction, defined as a complete response (CR) or partial response (PR) based on modified Cheson 2007 criteria (excluding PET) 2. For WM, best overall objective response (BOR), defined as a CR, very good partial response, PR, or minimum response, based on Owen 2013 criteria at any time during the study.
    3. For gastric MZL, OR at end of Induction, defined as a CR or probable minimal residual disease or responding residual disease, based on the histological grading system of GELA 2003 criteria 4. For splenic MZL, OR at end of Induction, defined as a CR or PR based on Matutes (2008)
    1.Per LCM e LZM nodale ed extranodale, risposta obiettiva al termine dell’induzione (EOI, End of Induction), definita come risposta completa (CR, Complete Response) o risposta parziale (PR, Partial Response) in base ai criteri modificati di Cheson del 2007 (esclusa la PET).
    2 Per MW, migliore risposta obiettiva complessiva (BOR, Best Overall Response), definita come CR, risposta parziale molto buona (VGPR, Very Good Partial Response), PR o risposta minima (MR, Minimal Response), in base ai criteri di Owen del 2013 in qualsiasi momento durante lo studio.
    3 Per LZM gastrico, risposta obiettiva al termine dell’induzione (EOI), definita come CR o probabile minima malattia residua (pMRD, probable Minimal Residual Disease), o malattia residua responsiva (rRD, responding Residual Disease), in base al sistema di classificazione del grado istologico dei criteri GELA del 2003.
    4 Per LZM splenico, risposta obiettiva al termine dell’induzione (EOI), definita come CR o PR in base ai criteri di Matutes (2008).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 3 & 4. At the end of induction 2. At any time during the study; up to approximately 54 months
    1,3 e 4 alla fine dell'induzione, 2 in qualsiasi momento durante lo studio; fino a circa 54 mesi
    E.5.2Secondary end point(s)
    1. Progression-free survival (PFS), defined as the time from enrolment to the first occurrence of PD or death, as determined by the investigator 2. BOR, defined as best response seen throughout study 3. Complete Response Rate defined as best response of CR 4. Duration of objective response, defined for responding patients as the first occurrence of a documented objective response to the time of progression or death from any cause, whichever occurs first 5. Time to next treatment, defined as the time from the date of enrolment to the start date of the next anti-lymphoma treatment (NALT) or death from any cause 6. Overall survival, defined as the time from the enrolment to death from any cause 7. Event free survival, defined as the time from enrolment to disease progression or relapse, death from any cause, as assessed by the investigator, or initiation of any NALT, whichever occurs first.8. Disease-free survival, defined as the time from the date of the first occurrence of a documented CR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator, for the subgroup of patients with a BOR of CR 9. Response rates for MCL and nodal/extranodal MZL using the assessment based on FDG-PET scans based on modified Cheson 2007 10. Safety: Incidence, nature and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) 11. Pharmacokinetic parameters of atezolizumab, obinutuzumab, and rituximab 12. Occurrence of anti-drug antibodies of atezolizumab, obinutuzumab, and rituximab
    1Sopravvivenza libera da progressione (PFS, Progression-Free Survival), definita come il tempo che intercorre tra l¿arruolamento e la prima manifestazione di una progressione, secondo il giudizio dello sperimentatore, oppure il decesso. 2Migliore risposta complessiva (BOR), definita come la migliore risposta registrata nel corso dell¿intero studio. 3Tasso di risposte complete (CRR, Complete Response Rate), definito come il tasso di conseguimento di CR come migliore risposta. 4Durata della risposta obiettiva (DOR, Duration Of Response), definita per i pazienti responsivi come il Atezolizumab/Obinutuzumab/Rituximab¿F. Hoffmann-La Roche Ltd Sinossi MO39107, Versione 1.0, 28 Apr 2017 tempo che intercorre tra la prima manifestazione di una risposta obiettiva documentata e la progressione o il decesso per qualsiasi causa, a seconda di quale delle due ipotesi si verifichi per prima. 5Tempo al trattamento successivo (TTNT, Time To Next Treatment), definito come il tempo che intercorre tra la data dell¿arruolamento e la data di inizio del successivo trattamento anti-linfoma (NALT, Next Anti-Lymphoma Treatment) o il decesso per qualsiasi causa. 6Sopravvivenza complessiva (OS, Overall Survival), definita come il tempo che intercorre tra l¿arruolamento e il decesso per qualsiasi causa. 7Sopravvivenza libera da eventi (EFS, Event Free Survival), definita come il tempo che intercorre tra l¿arruolamento e la progressione o una recidiva della malattia, secondo il parere dello sperimentatore, il decesso per qualsiasi causa oppure l¿inizio di un NALT, a seconda di quale delle ipotesi si verifichi per prima. 8Sopravvivenza libera da malattia (DFS, Disease-Free Survival), definita come il tempo che intercorre tra la data di una CR documentata e la data di progressione della malattia, recidiva della malattia o decesso per qualsiasi causa (PFS), secondo il parere dello sperimentatore, per il sottogruppo di pazienti con CR come migliore risposta complessiva (BOR). 9Tassi di risposta di LCM e LZM nodale/extranodale utilizzando le valutazioni basate sulle immagini FDG-PET in base ai criteri modificati di Cheson del 2007. 10Sicurezza: Incidenza, natura e severit¿ degli eventi avversi (AE, Adverse Event), classificati secondo i criteri terminologici comuni per gli eventi avversi del National Cancer Institute (NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events, v 4.03); variazione dei parametri vitali, dei risultati dell¿esame obiettivo, dell¿elettrocardiogramma (ECG) e delle analisi cliniche di laboratorio durante e dopo la somministrazione del farmaco in studio. 11Concentrazioni sieriche in punti temporali specifici e/o parametri farmacocinetici (PK, Pharmacokinetics) di atezolizumab e obinutuzumab. 12Concentrazioni sieriche in punti temporali specifici e/o parametri PK di atezolizumab e rituximab.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-10. Up to approximately 54 months 11. C1D1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1 (atezolizumab); C1D1, C2D1, C4D1 (obinutuzumab); C1D1, C2D1, C4D1, C8D1 (rituximab), end of treatment (EOT) and at Follow-up 1 (FU1) 12. C1D1, C2D1, C34D1, C4D1, C8D1, C12D1, C16D1 (atezolizumab); C1D1, C4D1 (obinutuzumab); C1D1, C4D1 (rituximab); EOT and at FU1
    1-10. fino a circa 54 mesi 11. C1D1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1 (atezolizumab); C1D1, C2D1, C4D1 (obinutuzumab); C1D1, C2D1, C4D1, C8D1 (rituximab), fine trattamento (EOT) e al FU 1 (FU1) 12. C1D1, C2D1, C34D1, C4D1, C8D1, C12D1, C16D1 (atezolizumab); C1D1, C4D1 (obinutuzumab); C1D1, C4D1 (rituximab); EOT e al FU1
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bosnia and Herzegovina
    Korea, Democratic People's Republic of
    Korea, Republic of
    Russian Federation
    Switzerland
    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 the study is defined as the date when the last patient, last visit (LPLV) occurs. LPLV is expected to occur approximately 54 months after the first patient is enrolled.
    La conclusione dello studio coincider¿ con la data dell¿ultima visita dell¿ultimo paziente (Last Patient, Last Visit, LPLV). Si prevede che ci¿ avverr¿ circa 54 mesi dopo l¿arruolamento del primo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months54
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 55
    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 post-trial access to obinutuzumab, rituximab, and atezolizumab free of charge to eligible patients with MCL, MZL, or WM in case the trial is stopped while patients are still on treatment as
    per the study protocol, in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    Lo Sponsor offrirà l'accesso post-trial ai farmaci obinutuzumab, rituximab e atezolizumab gratuitamente ai pazienti affetti da MCL, MZL o WM risultati eleggibili nel caso in cui lo studio termini mentre i pazienti sono ancora in trattamento in accordo al protocollo, in conformità con il Roche Global Policy sull'accesso continuo ai medicinali investigativi Prodotto.
    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 Decision2017-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
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