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    Summary
    EudraCT Number:2015-004845-25
    Sponsor's Protocol Code Number:BO29561
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-23
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-004845-25
    A.3Full title of the trial
    A phase Ib/II study evaluating the safety and efficacy of obinutuzumab in combination with atezolizumab plus polatuzumab vedotin in patients with relapsed or refractory follicular lymphoma and rituximab in combination with atezolizumab plus polatuzumab vedotin in patients with relapsed or reflractory diffuse large B-cell lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination with Atezolizumab plus Polatuzumab Vedotin in Patients with Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination with Atezolizumab plus Polatuzumab Vedotin in Patients with Relapsed or Refractory Diffuse large B-cell Lymphoma
    A.4.1Sponsor's protocol code numberBO29561
    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 Yes
    D.2.1.1.1Trade name Gazyvaro
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1325
    D.3 Description of the IMP
    D.3.1Product nameObinutuzumab
    D.3.2Product code RO5072759/F06
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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/F03
    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.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB126162
    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 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.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 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/F02
    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 nameDCDS4501s
    D.3.9.4EV Substance CodeSUB177827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number170
    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: 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
    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 nameRituximab
    D.3.2Product code RO0452294/ V1
    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.3.9.2Current sponsor codeRO 0452294/V1
    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 number100mg/10ml
    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: 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 MABTHERA
    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 nameRituximab
    D.3.2Product code RO0452294/ V1
    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.3.9.2Current sponsor codeRO 0452294/V1
    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 number500mg/50ml
    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.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
    Follicular Lymphoma (FL) or Diffuse Large B-cell Lymphoma (DLBCL)
    E.1.1.1Medical condition in easily understood language
    Lymphoma is a type of cancer of the white blood cells (these cells are part of the body's immune system)
    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 10016904
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III NOS
    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 determine the recommended Phase II dose (RP2D) for polatuzumab
    vedotin (Pola) when given in combination with fixed doses of
    obinutuzumab (G) and atezolizumab (Atezo)
    • To evaluate the safety and tolerability of the G + Atezo + Pola
    treatment group and the Rituximab (R) + Atezo + Pola treatment group
    • To evaluate the efficacy of induction treatment with G + Atezo + Pola
    in relapsed or refractory FL and R+ Atezo + Pola in relapsed or refractory
    DLBCL on the basis of the following endpoint:
    o Complete Response (CR) at end of induction (EOI), as
    determined by the investigator on the basis of positron emission
    tomography-computed tomography (PET-CT) scans
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of induction treatment with G + Atezo + Pola and maintenance treatment with G + Atezo in relapsed or refractory FL and of induction treatment with R + Atezo + Pola and consolidation treatment with R + Atezo in relapsed or refractory DLBCL
    •To characterize the pharmacokinetics (PK) of obinutuzumab, atezolizumab, rituximab and polatuzumab vedotin when given in combination
    •To evaluate the immune response to obinutuzumab, atezolizumab, rituximab and polatuzumab vedotin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >=18 years
    - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
    - For G + Atezo + Pola treatment group: relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
    - For R + Atezo + Pola treatment group: relapsed or refractory DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in patients who are not eligible for second line combination (immuno-)chemotherapy and autologous stem-cell transplantation or who have failed second line combination (immuno-)chemotherapy or experienced disease progression (DP) following autologous stem-cell transplantation
    - Histologically documented CD20-positive lymphoma as determined by the local laboratory
    - Fluorodeoxyglucose (FDG)-avid lymphoma (i.e., PET-positive lymphoma)
    - At least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by computed tomography (CT) scan or magnetic resonance imaging [MRI])
    - Availability of a representative tumour specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL
    - For women of childbearing potential, agreement to remain abstinent or to use single highly effective or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period for >= 5 months after the last dose of atezolizumab, >= 12 months after the last dose of rituximab, >= 12 months after the last dose of polatuzumab vedotin, and >=18 months after the last dose of obinutuzumab
    - 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 obinutuzumab, rituximab and atezolizumab, and 5 months after the last dose of polatuzumab vedotin and to refrain from donating sperm during this same period
    E.4Principal exclusion criteria
    - Grade 3b follicular lymphoma
    - History of transformation of indolent disease to DLBCL
    - Known CD20-negative status at relapse or progression
    - Central nervous system (CNS) lymphoma or leptomeningeal infiltration
    - Prior allogeneic stem-cell transplantation (SCT)
    - Completion of autologous SCT within 100 days prior to Day 1 of Cycle 1
    - Prior standard or investigational anti-cancer therapy
    - Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <= 2 (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) prior to Day 1 of Cycle 1
    - Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
    - History of solid organ transplantation and severe allergic or anaphylactic reaction to humanized, chimeric, or murine monoclonal antibodies
    - Known hypersensitivity or allergy to murine products and biopharmaceuticals or any component of the atezolizumab, obinutuzumab, rituximab or polatuzumab vedotin formulations
    - Known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
    - Active bacterial, viral, fungal, or other infection
    - Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
    - History of HIV positive status
    - History of progressive multifocal leukoencephalopathy
    - Vaccination with a live virus vaccine or live attenuated vaccine within 28 days prior to Day 1 of Cycle 1
    - History of other malignancy
    - History of autoimmune disease
    - Grade > 1 peripheral neuropathy present at screening
    - Any significant, uncontrolled concomitant disease
    - Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1
    - Inadequate haematologic and liver function (unless due to underlying lymphoma) defined as aspartate aminotransferase (AST) > upper limit of normal (ULN) or serum total bilirubin > ULN for patients enrolled in dose escalation phase and for the patients enrolled in the expansion phase the defined criteria is AST or alanine transaminase (ALT) > 2.5 × ULN and serum total bilirubin > 1.5 × ULN (or > 3 × ULN for patient with Gilbert syndrome
    - Abnormal laboratory values (unless due to underlying lymphoma)
    - Pregnant or lactating, or intending to become pregnant during the study
    - Life expectancy < 3 months
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    1. Incidence of dose-limiting toxicities (DLTs) during Cycles 1 and 2 of study treatment
    2. Nature, frequency, severity, and timing of adverse events
    3. Changes in clinical laboratory results during and following study treatment administration
    Efficacy:
    4. CR at EOI, as determined by the investigator on the basis of PET-CT scans based on Lugano 2014 criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day (D) 1-28 during Cycles (C) 1 and 2 of study treatment
    2. Up to 90 days after the last dose (LD) of study treatment
    3. Up to 90 days after the last dose (LD) of study treatment
    4. 6-8 weeks after Day 1 of the last induction cycle
    E.5.2Secondary end point(s)
    Efficacy:
    1. CR at EOI, as determined by the investigator on the basis of CT scans alone
    2. Objective response [CR or partial response (PR)] at EOI, as determined by the investigator on the basis of PET-CT scans
    3. Objective response at EOI, as determined and by the investigator on the basis of CT scans alone
    4. Best response during the study, as determined by the investigator on the basis of CT scans alone
    PK:
    6. Observed serum obinutuzumab concentration at specified timepoints
    7. Observed serum atezolizumab concentration at specified timepoints
    8. Observed serum and plasma concentrations of polatuzumab vedotin and relevant analytes [total antibody, antibody conjugated mono-methyl auristatin E (acMMAE), and unconjugated MMAE] at specified timepoints
    9. Observed serum rituximab concentration at specified timepoints
    Immunogenicity:
    10. Incidence of human anti-chimeric antibodies (HACAs) to rituximab during the study relative to the prevalence of HACAs at baseline
    11. Incidence of human anti-human antibodies (HAHAs) to obinutuzumab during the study relative to the prevalence of HAHAs at baseline
    12. Incidence of anti-therapeutic antibodies (ATAs) to atezolizumab during the study relative to the prevalence of ATAs at baseline
    13. Incidence of ATAs to polatuzumab vedotin during the study relative to the prevalence of ATAs at baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. 6−8 weeks after D1 of the last induction cycle
    4. Every 6 months after the induction treatment,until DP,initiation of another anti-lymphoma treatment or end of study, whichever occurs first
    5. D1, of C1, C2, C4, C6, D1 of Month (M)1,and of 7, 13, 19 in FL,treatment discontinuation (TD),120 days after LD
    6. At TD, 120 days after the LD
    7. Serum: D1 of C1, C2, C4, M1D1, TD, 120 days, and 1 yr after LD Plasma: C1D1, C1D8, C1D15, D1 of C2, C4, C6
    8-9. D1 of C1, C2, C4, C6, TD, 120 days, after LD
    10. C1D1, C6D1, TD, 120 days, after LD
    11. At TD and 120 days after LD
    12. D1 of C1, C2, C4, TD, 120 days, and 1 yr after LD
    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
    immunogenicity
    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
    ib safety and efficacy
    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.8.3 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 EEA16
    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
    Germany
    Poland
    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 time when both of the following criteria are met:
    • All enrolled FL patients have completed or discontinued study treatment (including induction treatment and maintenance treatment, as applicable).
    • All enrolled patients with DLBCL have been followed for at least 1 year after they have completed or discontinued study treatment (including induction treatment and consolidation treatment, as applicable).
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 86
    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)
    Currently,the Sponsor does not have any plans to provide obinutuzumab, atezolizumab, rituximab or polatuzumab vedotin or any other study treatments or interventions to patients who have completed the study.The Sponsor will evaluate whether to continue providing obi, ate, ritu or pola in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following Web site: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2016-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-07
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