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    Summary
    EudraCT Number:2017-002023-21
    Sponsor's Protocol Code Number:GO39942
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-29
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-002023-21
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL COMPARING THE EFFICACY AND SAFETY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB AND CHP (R-CHP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH
    DIFFUSE LARGE B-CELL LYMPHOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination with Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients with Diffuse Large B-Cell Lymphoma
    A.4.1Sponsor's protocol code numberGO39942
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-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 namepolatuzumab vedotin
    D.3.2Product code RO5541077
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLATUZUMAB VEDOTIN
    D.3.9.2Current sponsor codeRO5541077
    D.3.9.3Other descriptive nameDCDS4501A
    D.3.9.4EV Substance CodeSUB177827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vincristine Sulfate-TEVA
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVincristine sulfate
    D.3.9.3Other descriptive nameVINCRISTINE SULFATE
    D.3.9.4EV Substance CodeSUB05101MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for concentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diffuse large B-cell lymphoma (DLBCL)
    E.1.1.1Medical condition in easily understood language
    DLBCL is the most common type of non-Hodgkin lymphoma, and is marked by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012855
    E.1.2Term Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of polatuzumab vedotin plus rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) compared with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) with respect to progression-free survival (PFS)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of polatuzumab vedotin plus R-CHP compared with R-CHOP with respect to secondary efficacy endpoints
    • To evaluate the safety of polatuzumab vedotin plus R-CHP compared with R-CHOP
    • To characterize the pharmacokinetics of polatuzumab vedotin
    • To evaluate the immune response to polatuzumab vedotin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-80 years and willingness to comply with the study protocol procedures, including patient reported outcome measures
    - Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms:
    o DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type
    o T-cell/histiocyte-rich large B-cell lymphoma
    o Epstein-Barr virus-positive DLBCL, NOS
    o ALK-positive large B-cell lymphoma
    o HHV8-positive DLBCL, NOS
    o High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma)
    o High-grade B-cell lymphoma, NOS
    - Availability of archival or freshly collected tumor tissue before study enrollment
    - International Prognostic Index score of 2-5
    - Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
    - Life expectancy >= 12 months
    - At least one bi-dimensionally measurable lesion, defined as >= 1.5 cm in its longest dimension as measured by computed tomography or magnetic resonance Imaging
    - Ability and willingness to comply with the study protocol procedures, including patient reported outcome measures
    - Left ventricular ejection fraction >= 50% on cardiac multiple-gated acquisition scan or cardiac echocardiogram
    - Adequate hematologic function
    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. Women must refrain from donating eggs during this same period.
    - For women of childbearing potential, a negative serum pregnancy test result within 7 days prior to commencement of dosing
    - For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm for at least 5 months after the last dose of blinded polatuzumab vedotin/placebo, 3 months after the last dose of rituximab, and for at least 6 months after the last dose of blinded vincristine/placebo and cyclophosphamide to avoid exposing the embryo for the duration of the pregnancy
    E.4Principal exclusion criteria
    - Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
    - Prior organ transplantation
    - Current Grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
    - History of indolent lymphoma
    - Current diagnosis of the following: Follicular lymphoma grade 3B; Bcell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma, CNS lymphoma (primary or secondary involvement), primary effusion DLBCL, and primary cutaneous DLBCL
    - Prior treatment with cytotoxic drugs within 5 years of screening for any condition or prior use of any anti-CD20 antibody
    - Prior use of any monoclonal antibody within 3 months of the start of Cycle 1; any investigational therapy within 28 days prior to the start of Cycle 1; vaccination with live vaccines within 28 days prior the start of Cycle 1
    - Prior therapy for DLBCL
    - Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
    - History of other malignancy that could affect compliance with the protocol or interpretation of results
    - Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease
    - Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
    - History or presence of an abnormal electrocardiogram that is clinically significant in the investigator's opinion
    - Known active bacterial, viral, fungal, mycobacterial, parasitic or other infection at study enrollment or significant infections within 2 weeks before the start of Cycle 1
    - Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
    - Prior radiotherapy to the mediastinal/pericardial region
    - Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
    - Any of the abnormal laboratory values such as international normalization ratio > 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation, Partial thromboplastin time or activated partial thromboplastin time > 1.5 x ULN in the absence of a lupus anticoagulant, Serum aspartate aminotransferase and alanine aminotransferase >= 2.5 x ULN, Total bilirubin >= 1.5 x ULN, Serum creatinine clearance < 40 mL/min
    - Patients with suspected active or latent tuberculosis
    - Positive test results for chronic hepatitis B infection, hepatitis C, human T-lymphotrophic 1 virus
    - Known history of HIV seropositive status
    - Patients with a history of progressive multifocal leukoencephalopathy
    - Pregnancy or lactation or intending to become pregnant during study
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression-free survival as assessed by the investigator by using the Lugano Response Criteria for Malignant Lymphoma
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 65 months
    E.5.2Secondary end point(s)
    1. 2-year progression-free survival rate as determined by the investigator
    2. Event-free survival (efficacy) as determined by the investigator
    3. Complete response rate at end of treatment by fluorodeoxyglucose positron emission tomography as determined by blinded independent central review and by the investigator
    4. Overall Survival
    5. Disease-free survival
    6. Duration of response
    7. Event-free survival (all causes)
    8. Time to deterioration in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 questionnaire (EORTC QLQ-C30) physical functioning and fatigue and Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)
    9. Proportion of patients achieving meaningful improvement in EORTC QLQ-C30 physical functioning and fatigue, and FACT-Lym LymS
    10. EORTC QLQ-C30 rate of treatment-related symptoms and FACT/ Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity peripheral neuropathy rate
    11. Incidence, nature, and severity of adverse events, with severity determined through use of
    National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)
    12. Incidence of peripheral neuropathy rates and severity determined through use of NCI CTCAE v4.0
    13. Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to adverse events
    14. Dose intensities of study drugs
    15. Plasma and/or serum concentration of polatuzumab vedotin related analytes at specified time points
    16. Incidence of Anti-drug antibodies (ADAs) to polatuzumab vedotin during the study relative to the prevalence of ADAs to polatuzumab vedotin at baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At 24 months
    2-7. Up to approximately 65 months
    8-10. Day 1 of Cycle 1, 2, 3 and 5, at treatment completion, and post-treatment visits
    11-14. Up to approximately 65 months
    15-16. Day 1 of Cycle 1 and 4, at treatment completion and at 3 month post treatment follow-up visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient reported outcomes
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    polatuzumab vedotin + R-CHP + vincristine placebo versus polatuzumab vedotin placebo + R-CHOP
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA137
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    France
    Germany
    Hong Kong
    Israel
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Poland
    Portugal
    Russian Federation
    Spain
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 525
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 463
    F.4.2.2In the whole clinical trial 875
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor does not have any plans to provide Sponsor study drugs (polatuzumab vedotin, vincristine, or rituximab) or any other study treatments or interventions to patients who have completed the study. The Sponsor may evaluate
    whether to continue providing polatuzumab vedotin or rituximab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product available at the Roche Policy Web site
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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