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    Summary
    EudraCT Number:2008-005811-16
    Sponsor's Protocol Code Number:OMB110913
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-12
    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 ConcernedGreece - EOF
    A.2EudraCT number2008-005811-16
    A.3Full title of the trial
    A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects with Relapsed Chronic Lymphocytic Leukemia
    A.4.1Sponsor's protocol code numberOMB110913
    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 and 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.3.4Pharmaceutical 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 Information not present in EudraCT
    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 combination ofatumumab-fludarabine-cyclophosphamide therapy vs. fludarabine-cyclophosphamide therapy for the treatment of relapsed CLL.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate clinical benefit, changes in patient reported outcome (PRO) measures, safety, tolerability and pharmacokinetics of subjects treated with ofatumumab in combination with fludarabine and cyclophosphamide.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub-study will be conducted at selected sites in order to determine whether ofatumumab has an effect on the corrected QT interval (QTc) interval or on fludarabine or cyclophosphamide pharmacokinetics.

    Details are included in Appendix 6 of the protocol (OMB110913, dated 2008-08-22), Section 11.6.

    All patients enrolled at participating sites are encouraged to enroll in the QTc and drug-drug interaction sub-study in order to avoid patient selection bias. A total of 50 subjects (25 per treatment arm) will participate in the sub-study.

    Objectives:

    - To evaluate the potential effect of ofatumumab on QTc interval

    - To evaluate the potential effect of ofatumumab on fludarabine or cyclophosphamide pharmacokinetics
    E.3Principal inclusion criteria
    Subjects eligible for enrollment in the study must meet all of the following criteria:

    1. Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20, CD23, CD79b, and surface Ig prior to Visit 2

    2. Active disease and indication for treatment based on modified IWCLL updated NCI-WG guidelines [Hallek, 2008] defined by presenting at least one of the following conditions:
    • Evidence of progressive marrow failure as manifested by development of, or worsening of anemia, and/or thrombocytopenia
    • Massive (i.e., greater than 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
    • Massive nodes (i.e., greater than 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
    • Progressive lymphocytosis with an increase of more than 50% over a 2 month period or lymphocyte doubling time of less than 6 months
    • A minimum of any one of the following disease-related symptoms must be present:
    a. Unintentional weight loss more than or equal to 10% within the previous 6 months
    b. Fevers of greater than 100.5○F (38.0ºC) for 2 or more weeks without other evidence of infection
    c. Night sweats for more than 1 month without evidence of infection

    3. Relapsed CLL: defined as a subject who has received at least one prior CLL therapy and previously achieved a complete or partial remission/response, but after a period of 6 or more months, demonstrate evidence of disease progression [Hallek 2008].

    4. ECOG Performance Status of 0-2

    5. Life expectancy of at least 6 months

    6. Age ≥ 18 years

    7. 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. Refractory CLL: defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months of last anti-leukemic therapy [Hallek, 2008]

    2. Subjects with platelet count less than 50,000/microliter and ANC less than or equal to 1000/microliter

    3. Previous autologous or allogeneic stem cell transplantation

    4. Active Autoimmune Hemolytic Anemia (AIHA) requiring corticosteroid therapy greater than 100mg equivalent to hydrocortisone, or chemotherapy

    5. Known transformation of CLL (e.g. Richter’s Transformation/syndrome)

    6. Known CNS involvement of CLL

    7. 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

    8. 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

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

    10. History of significant cerebrovascular disease or event with significant symptoms or sequelae

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

    12. Known HIV positive

    13. Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HB DNA test will be performed and if positive the subject will be excluded. Note: If HBcAb positive and HBsAb positive, which is indicative of a past infection, the subject can be included.

    14. Screening laboratory values:
    • Creatinine > 1.5 times upper normal limit (unless normal creatinine clearance)
    • Total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of CLL)
    • Alanine Aminotransferase (ALT) > 3.0 times upper normal limit (unless due to liver involvement of CLL)

    15. Previous treatment or known or suspected hypersensitivity to ofatumumab

    16. 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 or currently participating in any other interventional clinical study

    17. Subjects known or suspected of not being able to comply with a study protocol

    18. 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).
    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 Information not present in EudraCT
    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) 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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 months6
    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) 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 Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 416
    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)
    After completion of the treatment phase (for subjects achieving CR, PR, or SD), survival and disease status assessments will be performed 1 month post treatment and every 3 months for 5 years. In addition, subjects will be monitored for safety, efficacy and pharmacokinetics. Follow-up assessment for subjects experiencing disease progression during the treatment phase requires a 1 month post-treatment safety assessment.
    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 Decision2009-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-25
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