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    Summary
    EudraCT Number:2009-017995-26
    Sponsor's Protocol Code Number:LNH2009-7B
    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:2010-06-14
    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 number2009-017995-26
    A.3Full title of the trial
    PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOULSY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA
    Etude de phase II évaluant l’efficacité de l’association miniCHOP plus ofatumumab chez des patients âgés de plus de 80 ans, atteints d’un lymphome diffus à grandes cellules B CD20+ non préalablement traités
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOULSY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA
    Etude de phase II évaluant l’efficacité de l’association miniCHOP plus ofatumumab chez des patients âgés de plus de 80 ans, atteints d’un lymphome diffus à grandes cellules B CD20+ non préalablement traités
    A.3.2Name or abbreviated title of the trial where available
    LNH09-7B
    A.4.1Sponsor's protocol code numberLNH2009-7B
    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 supportLaboratoire GlaxoSmithKline
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointLYSARC
    B.5.3 Address:
    B.5.3.1Street AddressCH Lyon Sud, Secteur Sainte Eugénie, Pavillon 6D
    B.5.3.2Town/ cityPierre Bénite
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number330472 66 93 33
    B.5.5Fax number330472 66 93 71
    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 nameofatumumab
    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.3.11 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    Diffuse large B Cell lymphoma
    E.1.1.1Medical condition in easily understood language
    Diffuse large B Cell 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 PT
    E.1.2Classification code 10003899
    E.1.2Term B-cell lymphoma
    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 efficacy of O-miniCHOP in patients aged over 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OS).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and the safety of O-miniCHOP as measured by the PFS (Progression Free Survival), EFS (Event Free Survival), response duration, the DFS (disease free survival) for complete responders and unconfirmed complete responders, response rate at the end of the treatment, the additional toxicities and evaluation of simplificated scale prognostic impact.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.)
    May also be included : de Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell infiltration in bone marrow
    - Or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
    - Or CD20+ Follicular lymphoma grade 3B
    - Or CD20+ Agressive B-cell lymphoma unclassifiable
    - Aged over 80 years.
    - Ann Arbor stage I, II, III or IV.
    - All aaIPI
    - Patient non previously treated.
    - All ECOG performance status
    - With a minimum life expectancy of 3 months.
    - Negative HIV, HBV and HCV serologies test ≤ 4 weeks (except after vaccination).
    - Patient able to give his consent and having previously signed a written informed consent.
    - Patient affiliated to social security system, if applicable.
    E.4Principal exclusion criteria
    - Any other histological type of lymphoma, Burkitt included.
    - Any history of treated or non-treated small-B cell lymphoma.
    - Central nervous system or meningeal involvement by lymphoma.
    - Contra-indication to any drug contained in the chemotherapy regimens.
    - Any serious active disease (according to the investigator’s decision).
    - Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
    - Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
    - Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score ≤7, and a prostate specific antigen (PSA) ≤10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) ≥2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
    - Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
    - Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
    - Adult patient under tutelage.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival will be measured to assess the benefit of ofatumumab associated to mini-CHOP from the date of inclusion to the date of death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival will be measured from the date of inclusion to the date of death from any cause. Patients who have not died at the time of the analysis or who are lost to follow-up will be censored at the date of last contact.
    E.5.2Secondary end point(s)
    PROGRESSION-FREE SURVIVAL (PFS)
    EVENT-FREE SURVIVAL (EFS)
    DISEASE-FREE SURVIVAL (DFS)
    DURATION OF RESPONSE RESPONSE RATE AT THE END OF TREATMENT
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS measured from the date of inclusion to the date of first documented disease progression, relapse or death from any cause, whichever occurs first. EFS measured from the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause.
    DFS measured from the time of attainment of CR, CRu or PR to the date of first documented disease progression, relapse or death as a result of lymphoma or acute toxicity of treatment.
    Duration of response measured from the time of attainment of CR/CRu or PR to the date of first documented disease progression, relapse or death from any cause. Response to treatment, assessed at the end of protocol therapy, will be classified as CR, CRu, PR, SD and PD.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    The end of the study corresponds to the last visit of last included patient
    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 months6
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    None
    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 Decision2010-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
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