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    Summary
    EudraCT Number:2007-004190-26
    Sponsor's Protocol Code Number:GEN415
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-004190-26
    A.3Full title of the trial
    An open-label, single-arm, multi-center phase 2 trial with ofatumumab in patients with relapsed/progressive Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed/progression after autologous transplant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, single-arm, multi-center phase 2 trial with ofatumumab in patients with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
    A.4.1Sponsor's protocol code numberGEN415
    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 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 supportGSK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Trial Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402089904466
    B.5.5Fax number+4402089901234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Yes
    D.2.1.1.1Trade name Arzerra
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 HuMax-CD20
    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 codeHuMax-CD20
    D.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Diffuse Large B-Cell Lymphoma
    E.1.1.1Medical condition in easily understood language
    Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoid malignancy and is a sub-group of non-Hodgkin’s lymphoma (NHL)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10012821
    E.1.2Term Diffuse large B-cell lymphoma recurrent
    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 investigate the efficacy of ofatumumab in patients with relapsed/progressive DLBCL ineligible for transplant or relapsed/progression after autologous transplant
    E.2.2Secondary objectives of the trial
    To determine the safety and pharmacokinetic (PK) profile of ofatumumab in patients with relapsed/progressive DLBCL ineligible for transplant or relapsed/progression after autologous transplant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with DLBCL:

    a. and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation

    b. and relapse after complete remission or disease progression after partial remission
    following autologous stem cell transplantation.

    2. Tumor verified to be CD20+ positive from excisional or incisional lymph node biopsy.
    3. CT scan in screening phase (based on local evaluation) showing:
    a. 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
    b. 1 clearly demarcated lesion with a largest diameter ≥ 2.0 cm
    4. ECOG Performance Status of 0, 1, or 2
    5. Age ≥ 18 years
    6. Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out
    E.4Principal exclusion criteria
    1. More than 1 previous radioimmunotherapy regimen
    2. Received radioimmunotherapy within 3 months prior to Visit 2
    3. Received any of the following treatments within 4 weeks prior to Visit 2:
    a. Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues)
    b. Glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day
    4. Received monoclonal antibodies, other than rituximab, within 3 months prior to Visit 2
    5. Patients previously treated with other anti-CD20 monoclonal antibodies than rituximab, tositumomab and ibritumomab tiuxetan (the latter two in accordance with exclusion criteria no.1 and 2)
    6. Patients with previously diagnosed and treated indolent lymphoma
    7. Known CNS involvement of DLBCL
    8. Past or current malignancy, except for:
    a. Cervical carcinoma Stage 1B or less
    b. Non-invasive basal cell and/or squamous cell skin carcinoma
    c. Malignant melanoma with a complete response of a duration of > 10 years
    d. Other cancer diagnoses with a complete response of a duration of > 5 years
    9. Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
    10. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure (NYHA III-IV), and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
    11. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
    12. History of significant cerebrovascular disease
    13. Known HIV positive
    14. Positive serology for hepatitis B (HB) defined as:
    a. Positive test for HBsAg and/or
    b. Positive test for anti-HBs and anti-HBc
    Patients with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will not be considered positive.

    15. Screening laboratory values:
    a. platelets < 50 x 10^9/L (unless due to DLBCL involvement of the bone marrow)
    b. neutrophils < 1.0 x 10^9/L (unless due to DLBCL involvement of the bone marrow)
    c. creatinine > 1.5 times upper normal limit (unless normal creatinine clearance)
    d. total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of DLBCL)
    e. ALT > 2.5 times upper normal limit (unless due to liver involvement of DLBCL)
    f. alkaline phosphatase > 2.5 times upper normal limit (unless due to liver involvement of DLBCL)
    16. Known or suspected hypersensitivity to components of investigational product
    17. Life expectancy less than 6 months
    18. Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 2
    19. Current participation in any other interventional clinical trial
    20. Patients known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
    21. Breast feeding women or women with a positive pregnancy test at Visit 1
    22. Women of childbearing potential not willing to use adequate contraception during trial and one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response as measured over a 6 month period from start of treatment with ofatumumab assessed according to the “Revised response criteria for malignant lymphoma”
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is Objective Response (OR)
    E.5.2Secondary end point(s)
    Duration of response, Progression Free survival, Overall survival, time to next DLBCL therapy, Adverse Events, HAHA, Pharmacokinetics
    E.5.2.1Timepoint(s) of evaluation of this end point
    Objective Response (OR) measured over a 6 month period from the start of study treatment. Other endpoints measured at regular intervals over a 60 month period
    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 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 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) 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.8.2.4Number of treatment arms in the trial1
    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 EEA61
    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
    Denmark
    France
    Italy
    Romania
    Spain
    United Kingdom
    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
    Last visit of last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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
    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.1.2.1Number of subjects for this age range: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 81
    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 Decision2008-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-19
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