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    Summary
    EudraCT Number:2010-020757-14
    Sponsor's Protocol Code Number:BRIEF
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-020757-14
    A.3Full title of the trial
    A multicentric phase II study evaluating the benefit of a short induction treatment by Bendamustine and Rituximab followed by maintenance therapy with rituximab In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma patients, with an intermediate or high FLIPI score
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bendamustine and rituximab in elderly untreated follicular lymphoma
    A.3.2Name or abbreviated title of the trial where available
    BRIEF
    A.4.1Sponsor's protocol code numberBRIEF
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01313611
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMundipharma
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportRoche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProfessor Pierre Feugier
    B.5.2Functional name of contact pointChairman of the study
    B.5.3 Address:
    B.5.3.1Street AddressCHU Brabois - Hematologie ; Rue du Morvan
    B.5.3.2Town/ cityVandoeuvre les Nancy
    B.5.3.3Post code54511
    B.5.3.4CountryFrance
    B.5.4Telephone number+33383 15 32 82
    B.5.5Fax number+33383 15 35 58
    B.5.6E-mailp.feugier@chu-nancy.fr
    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 LEVACT
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma 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.3.1Product namebendamustine
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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: 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 Ltd
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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
    Initial diagnosis of histologically confirmed follicular lymphoma
    E.1.1.1Medical condition in easily understood language
    Follicular lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the complete response rate according to Cheson criteria 1999 after a short induction treatment by Rituximab and Bendamustine in 1st line follicular lymphoma patients, ≥ 60 years old, with an intermediate or high FLIPI score, and without high tumor burden (according to GELF criteria)
    E.2.2Secondary objectives of the trial
    - Complete response rate at the end of induction according to Cheson 2007
    - Overall response rates at the end of induction phase
    - Overall response rate at the end of induction phase according to Cheson 2007
    - Response rates at the end of maintenance phase according to Cheson 1999
    - Response rates at the end of maintenance phase according toCheson 2007
    - Duration of response
    - Progression free survival
    - Overall survival
    - Time to next anti lymphoma treatment
    - Immediate toxicity (grades 3 and 4, during the twelve first weeks)
    - Long-term toxicity
    - QoL evaluation

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Predictive value or early response evaluated at week 12 by 18FDG-TEPStudy
    E.3Principal inclusion criteria
    • Histologically confirmed follicular lymphoma CD20+, all grades except the grade 3b with a lymph node biopsy performed within 6 months before study entry and with material available for central review
    • A minimal initial immunology is required, including : CD20, bcl-2, CD10 et CD5
    • Age must be ≥ 60 years.
    • Patients not previously treated.
    • Patients with an intermediate or high risk FLIPI score requiring with one or more of the following adverse prognostic factors:
    1. Ann Arbor Stage (I-II vs. III-IV)
    2. Hemoglobin level ( < 12g/dL vs. ≥ 12 g/dL)
    3. Number of nodal areas (< 5 vs. ≥ 5)
    • Patients with at least one measurable site of disease: patients with only blood or marrow or splenic infiltration are excluded
    • Performance status ≤ 2 on the ECOG scale
    • Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) including:
    Hemoglobin ≥ 8.0 g/dL (5.0 mmol/L)
    Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    Platelet count ≥ 100 x 109/L
    • Adequate renal function: calculated creatinine clearance > 50 ml/min (according to MDRD method) unless these abnormalities are related to lymphoma
    • Adequate hepatic function: Total bilirubin < 2.0 mg/dl (34 µmol/L), AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal unless these abnormalities are related to lymphoma
    • Adequate cardiac function: LEVF ≥ 50% calculated by echocardiography or scintigraphy
    • Having previously signed a written informed consent
    E.4Principal exclusion criteria
    • Other histological types of lymphoma than follicular lymphoma
    • Grade 3b follicular lymphoma
    • Patients previously on watch and wait since more than 6 months from diagnosis
    • Patients previously treated for lymphoma, except splenectomy
    • Bulky disease at study entry according to the GELF criteria
    • Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
    • Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer or previous cancer in CR without any treatment in the last 5 years
    • Known HIV infection or active HBV or HCV infection
    • Poor Performance status > 2 on the ECOG scale
    • Known contra-indication to study product
    • Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
    • Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent.


    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the response rate after a short treatment by rituximab and bendamustine instead of a watch-and-wait approach.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the completion of the induction phase for all the 62 included patients
    E.5.2Secondary end point(s)
    - Complete response rate at the end of induction according to Cheson 2007
    - Overall response rates at the end of induction phase according to Cheson 1999
    - Overall response rate at the end of induction phase according to Cheson 2007
    - Response rates at the end of maintenance phase according to Cheson 1999
    - Response rates at the end of maintenance phase according toCheson 2007
    - Duration of response
    - Progression free survival
    - Overall survival
    - Time to next anti lymphoma treatment
    - Immediate toxicity (grades 3 and 4, during the twelve first weeks)
    - Long-term toxicity
    - QoL evaluation
    E.5.2.1Timepoint(s) of evaluation of this end point
    - After the completion of the induction phase for all the 62 included patients
    - After the completion of the maintenance phase for all the 62 included patients
    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 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 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 concerned94
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA111
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    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 years9
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 62
    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)
    Patients will be treated according to local investigational use
    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 Decision2011-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-01
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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
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