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    Summary
    EudraCT Number:2008-004932-19
    Sponsor's Protocol Code Number:OMB110911
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-11-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-004932-19
    A.3Full title of the trial
    A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. Chlorambucil Monotherapy in previously untreated patients with Chronic Lymphocytic Leukemia
    A.4.1Sponsor's protocol code numberOMB110911
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code GSK1841157
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNOfatumumab
    D.3.9.2Current sponsor codeGSK1841157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Chronic Lymphocytic Leukaemia
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate progression-free-survival of ofatumumab added to chlorambucil therapy vs. chlorambucil therapy for the treatment of previously untreated (frontline) CLL.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate clinical benefit, safety, tolerability, changes in patient reported outcome measures (PRO) and pharmacokinetics of subjects treated with ofatumumab added to chlorambucil.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Drug-Drug Interaction and Electrocardiogram Sub-Study Protocol

    A sub-study will be conducted in order to determine whether ofatumumab has an effect on the corrected QT interval (QTc) or on chlorambucil pharmacokinetics. All patients enrolled at participating sites are encouraged to enroll in the ECG and drug-drug interaction sub-study in order to avoid patient selection bias.

    A minimum of 50 subjects (25 per treatment arm) will participate in the sub-study.
    Subject participating in the sub-study will not require any additional study visits to the visits required for the main study.

    Objectives:
    • To evaluate the potential effect of ofatumumab on QTc interval
    • To evaluate the potential effect of ofatumumab on chlorambucil pharmacokinetics

    Study Endpoints/Assessments:
    • QTcF (Fridericia-Corrected QT Interval)
    • Plasma ofatumumab concentrations
    • Plasma chlorambucil and phenylacetic acid mustard concentrations

    Full details are available in Appendix 5 of the amended protocol for OMB110911, dated 25th November 2009.
    E.3Principal inclusion criteria
    1. Diagnosis of CLL defined by:

    • Circulating lymphocytes ≥5,000/μL
    AND
    • Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20,
    CD23, CD79b, and surface Ig prior to Visit 2 Lymphocytosis with less than 5,000/μL B lymphocytes displaying the CLLimmunophenotype but in the absence of other features of a B-cell lymphoproliferate disorder (lymphadenopathy, organomegaly, cytopenias, disease-related symptoms) is defined as monoclonal B-lymphocytosis (MBL), not CLL.

    2. Considered inappropriate for fludarabine-based therapy, for reasons that include, but not limited to, advanced age or presence of co-morbidities

    3. Active disease and indication for treatment based on modified NCI-WG guidelines
    [Hallek, 2008] defined by presenting at least any one of the following conditions:

    • Evidence of progressive marrow failure as manifested by development or
    worsening of anemia and/or thrombocytopenia

    • Massive (i.e. at least 6cm below the left costal margin) or progressive or
    symptomatic splenomegaly

    • Massive nodes (i.e. at least 10cm in longest diameter) or progressive or
    symptomatic lymphadenopathy

    • Progressive lymphocytosis with an increase of more than 50% over a two month
    period or an lymphocyte doubling time of less than 6 months
    In patients with initial blood lymphocyte counts of less than 30x10^9/L,
    lymphocyte doubling time should not be used as a single parameter to define a
    treatment indication. In addition, factors contributing to lymphocytosis or
    lymphadenopathy other than CLL (eg, infections) should be excluded.

    • A minimum of any one of the following disease-related symptoms must be
    present:

    a) Unintentional Weight loss ≥ 10% within the previous six months;

    b) Fevers > 100.5°F (38.0°C) for ≥ 2 weeks without evidence of infection;
    or

    c) Night sweats for more than 1 month without evidence of infection

    4. Not been previously treated for CLL (prior autoimmune hemolytic anemia treatment permitted)

    5. ECOG Performance Status of 0-2

    6. Life expectancy of at least 6 months, in the opinion of the investigator

    7. Age ≥ 18 years

    8. Signed written informed consent prior to performing any study-specific procedures
    French subjects: In France, a subject will be eligible for inclusion in this study only if
    either affiliated to or a beneficiary of a social security category.
    E.4Principal exclusion criteria
    1. Prior immuno- or chemotherapy for CLL or small lymphocytic lymphoma (SLL)
    with any agent except corticosteroids used to treat autoimmune hemolytic anemia

    2. Previous autologous or allogeneic stem cell transplantation

    3. Active autoimmune hemolytic anemia (AIHA) requiring corticosteroid therapy >
    100mg/day equivalent to hydrocortisone, or chemotherapy*

    4. Known transformation of CLL (e.g. Richter)

    5. Known CNS involvement of CLL

    6. Chronic or current active infectious disease requiring systemic antibiotics,
    antifungal, or antiviral treatment such as, but not limited to, chronic renal infection,
    chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C

    7. Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible*

    8. Clinically significant cardiac disease including unstable angina, acute myocardial
    infarction within 6 months prior to screening (Visit 1), congestive heart failure, and
    arrhythmia requiring therapy, with the exception of extra systoles or minor
    conduction abnormalities*

    9. History of significant cerebrovascular disease or event with significant symptoms or
    sequelae*

    10. Glucocorticoid use, unless given in doses ≤ 100mg/day hydrocortisone (or equivalent dose of other glucocorticoid) for <7 days for exacerbations other than CLL (e.g. asthma)*

    11. Known HIV positive

    12. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In
    addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a
    HB DNA test will be performed and if positive the subject will be excluded.

    If HBV DNA is negative, subject may be included but must undergo HBV DNA
    monitoring (see Section 6.3.4). Prophylactic antiviral therapy may be initiated at the
    discretion of the investigator.

    13. Screening laboratory values:
    • Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance)

    • Total bilirubin > 2.0 times upper normal limit (unless due to liver involvement
    of CLL or due to Gilbert’s syndrome)

    • Alanine transaminase (ALT) > 3.0 times upper normal limit (unless due to liver
    involvement of CLL)

    14. Previous treatment or known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor is a contraindication to their
    participation in the present study

    15. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to Visit 1, whichever is longer,
    treatment with any anti-CD20 monoclonal antibody within 3 months of Visit 1, or
    participation in any other interventional clinical study. Note: Participation in any
    other interventional clinical study after disease progression during post PD-followup
    is permitted.

    16. Known or suspected inability to comply with study protocol

    17. Lactating women, women with a positive pregnancy test at Visit 1 or women (of
    childbearing potential) as well as men with partners of childbearing potential, who
    are not willing to use adequate contraception from study start through one year
    following last treatment dose. Adequate contraception is defined as abstinence, oral
    hormonal birth control, hormonal birth control injections, implants of levonorgestrel,
    estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and
    male partner sterilization if male partner is sole partner for that subject. The double
    barrier method can be used in regions where considered acceptable and adequate
    (condom or occlusive cap plus spermicidal agent).

    *Subjects can participate in the study if in the opinion of the investigator and medical
    monitor it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data.
    E.5 End points
    E.5.1Primary end point(s)
    • Progression free survival (PFS), defined as the interval between randomization until disease progression or death.
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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 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.8.3 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 EEA97
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    See protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days21
    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.1.3Elderly (>=65 years) Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 355
    F.4.2.2In the whole clinical trial 522
    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 Decision2010-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-17
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