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    Summary
    EudraCT Number:2009-012518-39
    Sponsor's Protocol Code Number:OMB112517
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-01-20
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-012518-39
    A.3Full title of the trial
    A phase III, open label, randomized, multicenter trial of ofatumumab maintenance treatment versus no further treatment in subjects with relapsed chronic lymphocytic leukemia (CLL) who have responded to induction therapy

    Otevřená, randomizovaná, multicentrická studie fáze III – udržovací léčba ofatumumabem oproti žádné další léčbě u osob s relapsem chronické lymfocytární leukémie (CLL) s dobrou odpovědí na indukční léčbu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see if ofatmumab helps response last longer after treatment for relapsed CLL compared to watching and re-treaing CLL
    A.3.2Name or abbreviated title of the trial where available
    PROLONG
    A.4.1Sponsor's protocol code numberOMB112517
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1148-0253
    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 AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1 Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 61 324 1111
    B.5.5Fax number+41 61 324 8001
    B.5.6E-mailclinicaltrial.enquiries@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.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeGSK1841157
    D.3.9.4EV Substance CodeSUB25221
    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 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
    Chronická lymfocytární leukemie
    E.1.1.1Medical condition in easily understood language
    Chronic lymphocytic leukemia is a cancer of the B-cels (a type of blood cell)
    Chronická lymfocytární leukemie je nádorové onemocnění vycházející z B- buněk (typ krevních buněk)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate progression free survival (PFS) of ofatumumab maintenance treatment
    versus no further treatment after remission induction in subjects with relapsed Chronic Lymphocytic Leukaemia
    E.2.2Secondary objectives of the trial
    • Secondary objectives are to evaluate clinical benefit, safety, tolerability and health-related quality of life of
    subjects treated with ofatumumab versus no further treatment. An additional secondary objective is to evaluate
    the pharmacokinetics in CLL subjects on maintenance ofatumumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines
    [Hallek, 2008]
    2. At least PR according to the revised 2008 NCI-WG CLL criteria, within 3 months of the response assessment
    after the last dose of 2nd/3rd line treatment
    3. The anti-leukemic treatment before study entry should have been at least 3 months or 3 cycles of
    polychemotherapy (e.g. CVP), fludarabine-containing chemotherapy or immunochemotherapy
    4. ECOG Performance Status of 0-2
    5. 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.
    E.4Principal exclusion criteria
    1. Known primary or secondary fludarabine-refractory subjects, defined as treatment failure (failure to achieve a
    CR or PR) or disease progression within 6 months [Hallek, 2008]
    2. Prior maintenance therapy
    3. Known transformation of CLL (e.g. Richter’s transformation), prolymphocytic leukemia (PLL), or CNS
    involvement of CLL
    4. Active Autoimmune Hemolytic Anemia (AIHA) requiring treatment except 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
    5. Previous autologous or allogeneic stem cell transplantation
    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 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 HBV DNA test will be performed and if positive the subject
    will be excluded*.)
    7. 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 except 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
    8. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months
    prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles
    or minor conduction abnormalities except 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. History of significant cerebrovascular disease or event with symptoms or sequelae
    10. Significant concurrent, uncontrolled medical condition that in the opinion of the investigator contraindicates
    participation in this study
    11. Other anti-leukemic use of medications including glucocorticoids
    12. Known HIV positive
    13. Screening laboratory values:
    • Platelets<50 x 10^9/L
    • Neutrophils<1.0 x 10^9/L
    • 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) > 2.5 times upper normal limit (unless due to liver involvement of CLL or
    Gilbert's syndrome)
    • Alkaline phosphatase > 2.5 times upper normal limit
    14. Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor
    contraindicates study participation
    15. Subjects who have received treatment with any non-marketed drug substance or experimental therapy
    within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication 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.
    16. 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. For
    females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap
    plus spermicidal agent).
    * 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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression-free-survival (PFS) which is defined as the time from randomization to the
    date of disease progression or death due to any cause. The investigator assessment of response will be assessed
    according to the IWCLL updated NCI-WG CLL criteria [Hallek, 2008].
    E.6
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 3 Cycles of ofatumumab plus bendamustine treatment. Last Subject = approx. Nov-2012
    After 6 Cycles of ofatumumab plus bendamustine treatment. Last Subject = approx. Feb-2013
    After the last dose, if not after 6 cycles, of ofatumumab plus bendamustine treatment. Last Subject = approx. Feb-2013
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    sledování
    observation only
    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 EEA98
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Czech Republic
    Germany
    Greece
    Italy
    Poland
    Russian Federation
    Spain
    United States
    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
    not applicable
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    E.8.9.2In all countries concerned by the trial months6
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 372
    F.4.2.2In the whole clinical trial 532
    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)
    Survival and disease status assessments will be performed post treatment every 3 months for 5 years after last
    treatment. CT scans will be done yearly.Subjects demonstrating disease progression will be followed for
    survival status until study completion. Follow-up assessment after disease progression on treatment will include
    a 1 month post-treatment safety assessment and subsequent follow-up visits to assess survival status, date of next
    CLL therapy, type of therapy, response to therapy.
    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 Decision2010-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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