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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001039-29
    Sponsor's Protocol Code Number:GO40515
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-001039-29
    A.3Full title of the trial
    A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED, CONTROLLED STUDY INVESTIGATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH CHOP OR CHP-POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with CHOP or CHP-Polatuzumab Vedotin in Patients with B Cell Non-Hodgkin Lymphoma
    A.4.1Sponsor's protocol code numberGO40515
    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
    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 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/F02-02
    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.3.9.1CAS number 1313206-42-6
    D.3.9.2Current sponsor codeRO5541077
    D.3.9.3Other descriptive nameDCDS4501A/DCDS4501S
    D.3.9.4EV Substance CodeSUB177827
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRO0452294
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 RoActemra
    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 nameTocilizumab
    D.3.2Product code RO4877533/F01-02
    D.3.4Pharmaceutical form Concentrate and solvent 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 (B-cell NHL)
    E.1.1.1Medical condition in easily understood language
    B-cell NHL is cancer that originates in your lymphatic system, the disease-fighting network spread throughout body. In NHL, tumors develop from B-lymphocytes -a type of white blood cell
    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
    Phase Ib
    Mosunetuzumab + cyclophosphamide, doxorubicin, vincristine, prednisone (M-CHOP):
    •To evaluate safety, tolerability of M-CHOP in patients with relapsed or refractory (R/R) B-cell NHL including estimation of the maximum tolerated dose (MTD), determination of recommended Phase II dose (RP2D), and characterization of dose-limiting toxicities (DLTs)
    Mosunetuzumab + cyclophosphamide, doxorubicin, prednisone, polatuzumab vedotin (M-CHP-pola):
    •To evaluate the safety and tolerability of M CHP-pola in patients with relapsing/refractory (R/R) B-cell NHL, including estimation of the MTD, determination of RP2D, and characterization of DLTs
    Phase II
    To evaluate
    •Efficacy of M-CHP-pola compared with rituximab (R)-CHP-pola in patients with previously untreated diffuse large B-cell lymphoma (DLBCL)
    E.2.2Secondary objectives of the trial
    Phase Ib
    To evaluate
    •Pharmacokinetics (PK) of mosunetuzumab when administered in combination with CHOP/CHP-pola, polatuzumab vedotin when administered in combination with mosunetuzumab, CHP
    •Relationship between serum PK, safety, biomarkers, efficacy
    •Preliminary assessment of anti-tumor activity of M-CHOP and M-CHP-pola
    Phase II
    •Efficacy of M-CHP-pola compared with R-CHP-pola in patients with previously untreated DLBCL
    •Efficacy of M-CHOP in patients with previously untreated DLBCL
    Phase Ib and II
    •Immune response to mosunetuzumab, polatuzumab vedotin and potential effect of mosunetuzumab, polatuzumab vedotin anti-drug antibody (ADA) incidence on relevant clinical outcomes
    •Safety, tolerability of M-CHP-pola compared with R-CHP-pola, M-CHOP
    •PK of mosunetuzumab when administered by IV infusion with CHOP, CHP-pola, polatuzumab vedotin when administered by IV infusion with mosunetuzumab, CHP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase Ib and Phase II
    - Age >= 18 years
    - At least one bi-dimensionally measurable nodal lesion
    - Life expectancy of at least 24 weeks
    - Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
    - Left ventricular ejection fraction defined by multiple-gated acquisition scan or echocardiogram within the institutional limits of normal
    - Adequate hematologic function
    - Contraception use
    Phase Ib
    - Histologically confirmed B-cell NHL according to WHO 2016 classification
    - R/R B-cell NHL after at least one prior systemic lymphoma therapy
    - Treatment with at least one prior CD20-directed therapy
    - Group B only: no prior treatment with polatuzumab vedotin
    Phase II
    - Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
    - International Prognostic Index score of 2-5
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding, or intending to become pregnant during the study
    - Prior treatment with mosunetuzumab and prior stem-cell transplant
    - Contraindication to receive full dose of any of the individual components
    - Current Grade >1 peripheral neuropathy
    - Received systemic immunosuppressive medications
    - Current or past history of central nervous system (CNS) lymphoma
    - Current or past history of CNS disease
    - Prior radiotherapy to the mediastinal/pericardial region
    - History of other malignancy
    - Recent major surgery
    Phase Ib
    - Prior treatment with >250 mg/m2 doxorubicin (or equivalent anthracycline dose)
    - Prior treatment with chemotherapy, immunotherapy, and biologic therapy within a specified period
    - Prior treatment with radiotherapy within a specified period
    - Adverse events from prior anti-cancer therapy resolved to <= Grade 1
    Phase II
    - Patients with transformed lymphoma
    - Prior therapy for B-cell NHL
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib
    1.Occurrence and severity of adverse events
    2.Occurrence of DLT with severity determined according to NCI CTCAE v5.0
    3.Change from baseline in targeted vital signs
    4.Change from baseline in targeted clinical laboratory test results
    5.Number of cycles received and dose density and intensity
    Phase II
    6.Complete response (CR) rate at the time of primary response assessment (PRA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 60 months
    2. C1D1 through C1D21
    3-4. From baseline to 60 months
    5. Up to 60 weeks
    6. Up to 60 months
    E.5.2Secondary end point(s)
    1.Maximum serum concentration (Cmax) of mosunetuzumab
    2.Minimum serum concentration (Cmin) of mosunetuzumab
    3.Total exposure (AUC) of mosunetuzumab
    4.Clearance of mosunetuzumab
    5.Volume of distribution of mosunetuzumab at steady state
    6.Relationship between serum pharmacokinetics and safety, biomarkers, or efficacy endpoints
    7.Complete response rate at the time of primary response assessment
    8.Best overall response rate and ORR
    9.Duration of response
    10.Progression free survival
    11.Progression free survival at 1 year
    12.Event-free survival
    13.Time to deterioration
    14.Occurrence and severity of adverse events including DLTs
    15.Incidence of ADAs to mosunetuzumab
    16.Incidence of ADAs to polatuzumab vedotin
    17.Relationship between ADAs and PK, safety, efficacy, and biomarkers
    18.Occurrence and severity of adverse events
    19.Change from baseline in targeted vital signs
    20.Change from baseline in targeted clinical laboratory test results and clinical assessments
    21.Number of cycles received and dose density and intensity
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-6. Up to 60 weeks
    7-10. Up to 60 months
    11. At 1 year
    12-13. Up to 60 months
    14. C1D1 through C1D21
    15-16. Up to 60 weeks
    17-19. Up to 60 months
    20. From baseline (-14 days) to up to 60 months
    21. Up to 60 weeks
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, immunogenicity, biomarkers
    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
    Phase Ib - 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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 EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    France
    Korea, Republic of
    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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 160
    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, polatuzumab vedotin, rituximab, 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 4.3.6
    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 Decision2019-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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