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    Summary
    EudraCT Number:2018-003255-38
    Sponsor's Protocol Code Number:MO40597
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-003255-38
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF GAZYVA SHORT DURATION INFUSION (SDI) IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED FOLLICULAR LYMPHOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Gazyva Short Duration Infusion (SDI) in Patients with Previously Untreated Follicular Lymphoma
    A.4.1Sponsor's protocol code numberMO40597
    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
    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
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Follicular lymphoma
    E.1.1.1Medical condition in easily understood language
    Follicular lymphoma (FL) is one of the most common common B cell-indolent non-Hodgkin's lymphomas (NHL) [type of blood cell cancer of the 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 HLT
    E.1.2Classification code 10016903
    E.1.2Term Follicle centre lymphomas, follicular grade I, II, III
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061170
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III
    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 safety of obinutuzumab administered as a short duration infusion (SDI) during cycle 2 and in patients with previously untreated advanced FL on the basis of the incidence of Grade >=3 infusion-related reactions (IRRs) during cycle 2 in patients who had previously received obinutuzumab at the standard infusion rate without experiencing a Grade 3 or 4 IRR
    E.2.2Secondary objectives of the trial
    To evaluate the safety and efficacy of obinutuzumab administered as an SDI from cycle 2 in patients with previously untreated advanced FL on the basis of objective response rate and complete response rate, progression-free survival rate and overall survival, as determined by the investigator.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Able and willing to comply with all study related procedures including completion of patient-reported outcome endpoints
    - Ability to comply with the study protocol, in the investigator's judgment
    - Patients with previously untreated Stage III or IV FL or Stage II bulky disease scheduled to receive obinutuzumab and chemotherapy due to at least one of the following criteria:
    o Bulky disease
    o Local symptoms or compromise of normal organ function due to progressive nodal disease or extranodal tumor mass
    o Presence of B symptoms
    o Presence of symptomatic extra nodal disease
    o Cytopenias due to underlying lymphoma
    o Involvement of >= 3 nodal sites, each with a diameter of >= 3 cm
    o Symptomatic splenic enlargement
    - Histologically documented CD-20-positive FL, as determined by the local laboratory
    - Eastern Cooperative Oncology Group performance status 0−2
    - Adequate hematologic function
    - Life expectancy of >= 12 months
    - For women who are not postmenopausal or surgically sterile: 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 18 months after the last dose of obinutuzumab, for at least 3 months after the last dose of bendamustine or according to institutional guidelines for cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or cyclophosphamide, vincristine, and prednisone chemotherapy, whichever is longer
    - For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, with female partners of childbearing potential, men must remain abstinent or 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 study treatment
    E.4Principal exclusion criteria
    - Relapsed / refractory FL
    - Prior treatment for FL with chemotherapy or immunotherapy
    - Grade IIIb FL
    - Histological evidence of transformation of FL into high-grade B-cell NHL
    - Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone/prednisolone/methylprednisolone (at a dose equivalent to >30 mg/day prednisone), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
    - History of solid organ transplantation and anti-CD20 antibody therapy
    - History of severe allergic or anaphylactic reaction to humanized, chimeric, or murine monoclonal antibodies
    - Known sensitivity or allergy to murine products, hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any of the study drugs and history of HIV positive status
    - Active bacterial, viral, fungal, or other infection or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
    - Positive test results for chronic HBV infection, hepatitis C
    - History of progressive multifocal leukoencephalopathy and prior other malignancy
    - Vaccination with a live virus vaccine within 28 days prior to Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study
    - Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or significant pulmonary disease
    - Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1, Day 1, or anticipation of a major surgical procedure during the course of the study
    - For patients who will be receiving CHOP: left ventricular ejection fraction < 50% by multigated acquisition scan or echocardiogram
    - Any of the following abnormal laboratory values
    o Creatinine > 1.5 × the upper limit of normal (ULN) or creatinine clearance < 40 mL/min
    o AST or ALT > 2.5 × ULN
    o Total bilirubin ≥ 1.5 × the ULN: Patients with documented Gilbert disease may be enrolled if total bilirubin is <= 3.0 × the ULN
    o International normalized ratio (INR) > 1.5 in the absence of therapeutic anticoagulation
    o Partial thromboplastin time or activated partial thromboplastin time > 1.5 × ULN in the absence of a lupus anticoagulant
    - Pregnant or lactating, or intending to become pregnant during the study
    - Any investigational therapy within 28 days prior to the start of Cycle 1
    - Positive test results for human T-lymphotropic virus 1 (HTLV-1), evaluated in endemic Countries
    - Development of a Grade >=4 infusion-related reaction (IRR) during Cycle 1

    E.5 End points
    E.5.1Primary end point(s)
    1. The incidence of Grade >=3 IRRs during cycle 2 in patients who had previously received obinutuzumab at the standard infusion rate during cycle 1 without experiencing a Grade 3 or 4 IRR, with severity determined according to NCI CTCAE Version 5.0
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Cycle 2
    E.5.2Secondary end point(s)
    Safety
    1. Incidence, nature, and severity of all AEs
    2. Time to IRR (in hours) from infusion to onset of the IRR during cycle 2
    3. Incidence of IRRs regardless of grade by cycle (separately)
    4. Duration (in minutes) of obinutuzumab administration by cycle (all cycles including maintenance)
    5. Type and duration of Grade >=3 IRRs, during all cycles, where obinutuzumab was administered as an SDI.

    Efficacy
    6. Objective response rate at the end of induction therapy as determined by the investigator and according to the guidelines used at the site
    7. Progression-free survival rate at the end of the study
    8. Overall survival at the end of the study
    9. Complete response rate at 30 months as assessed by the investigator and according to the guidelines used at the site
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Approximately 2.75 years
    2-5. Day 1, 8, 15 of Cycle 1; Day 1 of Cycle 2; Day 1 of Cycle 3-6/8 and Maintenance (every 8 weeks +-10 days)
    6-8. Up to 2.75 years
    9. At 30 months
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    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 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
    Brazil
    Germany
    Japan
    Netherlands
    Slovakia
    Spain
    United Kingdom
    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 the study is defined as the Last Patient, Last Visit (LPLV) which will occur when all patients have completed 3 months of follow-up for safety, or earlier, if one of the following is documented:
    Withdrawal of consent, completed the safety follow-up after discontinuing obinutuzumab for patients in the maintenance or induction phase, Lost to follow-up or death.
    In addition, the Sponsor may decide to terminate the study at any time.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    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 months8
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 112
    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 the Roche IMP (obinutuzumab) or any other study treatments or interventions to patients who have completed the study.
    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 Decision2019-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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