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    Summary
    EudraCT Number:2010-023066-52
    Sponsor's Protocol Code Number:OMB114242
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-05-05
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-023066-52
    A.3Full title of the trial
    An open label, multicenter study investigating the safety and efficacy of ofatumumab therapy versus physicians' choice in patients with bulky fludarabine refractory chronic lymphocytic leukaemia (CLL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of ofatumumab to treat leukaemia with bulky lymph nodes
    A.4.1Sponsor's protocol code numberOMB114242
    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 SponsorNovartis Pharma Services AG
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressStella-Klein-Löw-Weg 17
    B.5.3.2Town/ cityVienna
    B.5.3.3Post codeA-1020
    B.5.3.4CountryAustria
    B.5.4Telephone number +43 1 86657 0
    B.5.5Fax number +43 1 86657 6458
    B.5.6E-mailaustria.dra@novartis.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 No
    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/3/08/581
    D.3 Description of the IMP
    D.3.1Product nameOfatumumab
    D.3.2Product code GSK1841157
    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 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 number20
    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
    Chronic lymphocytic leukaemia
    E.1.1.1Medical condition in easily understood language
    Chronic lymphocytic leukemia is a cancer of the B-cells (a type of blood cell)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10068852
    E.1.2Term B-cell chronic lymphocytic leukaemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the improvement in progression free survival (PFS), defined as the time from randomization to the date of disease progression or death due to any cause, in subjects with bulky fludarabine-refractory CLL receiving ofatumumab compared to physicians’ choice.
    E.2.2Secondary objectives of the trial
    • To evaluate overall response rate (ORR) - defined as the percentage of subjects achieving either a confirmed complete response (CR) or a partial response (PR).
    • To evaluate overall survival (OS), defined as the time from randomization to death.
    • To evaluate the safety and tolerability in subjects with CLL receiving ofatumumab compared to physicians choice during the treatment period
    • To evaluate the health-related quality of life in subjects with CLL receiving ofatumumab compared to physicians’ choice, as assessed by changes in patient reported outcome (PRO) measures relative to baseline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the study treatment(s) that may impact subject eligibility is provided in the IB and summary of product characteristics (SmPC) for Arzerra, and the prescribing information of marketed products used as physicians’ choice.
    Subjects eligible for enrollment in the study must meet all of the following criteria:

    1. Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines.
    2. Have bulky lymphadenopathy, defined as at least 1 lymph node >5cm
    3. The subject must be refractory to fludarabine treatment, defined as:
    a. No response to at least 2 cycles of a fludarabine-containing regimen, or
    b. A partial response or better after at least 2 cycles of a fludarabine-containing regimen for a duration of less than 6 months
    4. Active disease requiring CLL therapy
    5. Age atleast ≥ 18 years of age
    6. Had at least 2 prior therapies for CLL
    7. ECOG Performance Status of 0-2
    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
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Prior allogeneic stem cell transplantation at any time, or prior autologous stem cell transplantation within 6 months of planned randomization.
    2. Treatment with any known unapproved drug substance or experimental therapy within 4 weeks prior to planned dosing, or currently participating in any other interventional clinical study. Note: Participation in any other interventional clinical study after disease progression during post PD follow-up is permitted.
    3. Known transformation of CLL (e.g. Richter’s transformation), prolymphocytic leukaemia (PLL), or CNS involvement of CLL.
    4. Active Autoimmune Haemolytic Anaemia (AIHA) requiring treatment except if associated with progressive disease requiring anti-CLL treatment.
    5. 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 B or C (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 7.3.3.4 of study protocol). Prophylactic antiviral therapy may be initiated at the discretion of the investigator.
    Consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive.
    6. Known HIV positive.
    7. Significant concurrent, uncontrolled medical condition that in the opinion of the investigator contraindicates participation in this study.
    8. Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry or if in the opinion of the investigator it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data.
    9. Non-protocol corticosteroid usage except a maintenance dose corresponding to ≤ 10 mg of prednisone at the time of planned dosing.
    10. Screening laboratory values:
    • Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance) or,
    • Total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of CLL or due to Gilbert’s syndrome) or,
    • Alanine transaminase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
    11. Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator is a contraindication to their participation in the present study
    12. 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 ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that subject.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement in progression-free survival (PFS), which is defined as the time from randomisation to the date of disease progression or death due to any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Calculated from entry into the study until the time of disease progression (or death due to any cause). To be evaluated when full number of events are reached (95 events).
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints of this study are:
    ● Overall response rate (ORR), defined as the percentage of subjects achieving either a confirmed complete response (CR) or a partial response (PR).
    ● Overall survival, defined as the time from randomisation to death.
    ● Safety and tolerability during the treatment period:
    - Incidence and severity of AEs collected from the first dose of treatment to 60 days after the last dose of treatment.
    - Incidence and severity of SAEs collected from the first dose of treatment to the end of the follow-up period, or until initiation of subsequent, non-study related anticancer therapy -assessed at each visit (evaluated at end of study)
    ● Changes in patient reported outcome (PRO) measures - assessed at
    baseline, every 12 weeks up to week 48 and at and every 3 months at
    Follow-up visits to Month 60 from start of treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Overall response rate (ORR), defined as the percentage of subjects achieving either a confirmed complete response (CR) or a partial response (PR) - assessed every 4 weeks for Months 1 to 6, every 8 weeks for Months 7 to 12 and every 3 months in Follow-up to Month 60 from start of treatment.
    •Overall survival, defined as the time from randomisation to death –
    assessed every 4 weeks for Months 1 to 6, every 8 weeks for Months 7 to 12 and every 3 months in Follow-up to Month 60 from start of treatment (~ every 3 months in survival follow-up) until time of 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 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient Reported Outcomes
    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 Yes
    E.8.2.3.1Comparator description
    Physicians' choice
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Austria
    Belgium
    Bulgaria
    Czech Republic
    France
    Germany
    Ireland
    Israel
    Italy
    Poland
    Russian Federation
    Singapore
    Slovakia
    Sweden
    Ukraine
    United Kingdom
    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
    End of trial is last patient last visit
    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 years7
    E.8.9.2In all countries concerned by the trial months11
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 53
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    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)
    Post study treatment will not be provided as part of the protocol. Upon discontinuation
    from assigned study treatment, subjects may receive additional (non protocol) therapy at
    the discretion of the treating physician.
    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 Decision2011-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-04-24
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