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    Summary
    EudraCT Number:2012-005223-32
    Sponsor's Protocol Code Number:OMB116481
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-12
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-005223-32
    A.3Full title of the trial
    A Phase II trial of Ofatumumab in patients with lymphoma of the of the mucosa associated lymphoid tissue (MALT-Lymphoma)
    Ofatumumab (Arzerra®) bei Patienten mit Lymphom des Mukosa-assoziierten lymphatischen Gewebes (MALT-Lymphom) - eine monozentrische Phase II Studie (O-MA 1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ofatumumab in patients with lymphoma of the of the mucosa associated lymphoid tissue (MALT-Lymphoma)
    Antikörpertherapie mit Ofatumumab bei Patienten mit bösartiger Erkrankung des schleimhaut-assoziierten lymphatischen Gewebes
    A.3.2Name or abbreviated title of the trial where available
    O-MA 1
    O-MA1
    A.4.1Sponsor's protocol code numberOMB116481
    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 SponsorMedizinische Universität Wien, Klinik für Innere Medizin I, Abt. Onkologie
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Pharma GmbH
    B.5.2Functional name of contact pointDr. Bernhard Lagg
    B.5.3 Address:
    B.5.3.1Street AddressAlbert Schweitzer-Gasse 6
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1140
    B.5.3.4CountryAustria
    B.5.4Telephone number00431970 750
    B.5.5Fax number00431970 75170
    B.5.6E-mailbernhard.b.lagg@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 holderGSK
    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 OMB116481
    D.3.4Pharmaceutical form Concentrate and solvent 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.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 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
    LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT-LYMPHOMA)
    Lymphom des Mukosa-assoziierten lymphatischen Gewebes (MALT-Lymphom)
    E.1.1.1Medical condition in easily understood language
    LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE
    Bösartige Erkrankung des Schleimhaut-assoziierten lymphatischen Gewebes
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10061850
    E.1.2Term Extranodal marginal zone B-cell lymphoma (MALT type)
    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
    Efficacy of IMP in patients with MALT-Lymphoma
    Wirksamkeit von Ofatumumab bei Patienten mit MALT-Lymphom
    E.2.2Secondary objectives of the trial
    Tolerability and safety of IMP in patients with MALT-Lymphoma
    Verträglichkeit von Ofatumumab bei Patienten mit MALT-Lymphom
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed MALT lymphoma (CD20+) with measurable disease (stage I – IV)
    • Gastric lymphoma: First or greater relapse after surgery, radiation, chemotherapy or HP-eradication (patients judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication in case of HP-positive gastric lymphoma) or refractoriness/persistence to the said measures. HP-negative patients are directly eligible and no initial attempt with antibiotics is considered in daily practice, as efficacy is low.
    • Extragastric lymphoma: Measurable disease stage I - IV
    • Age > 18 years
    • Life expectancy of at least 3 months
    • Patient must be able to tolerate therapy, and have adequate cardiac, renal and liver function
    • ECOG status of  2
    • Patient must be capable of understanding the purpose of the study and have given written informed consent.

    E.4Principal exclusion criteria
    • Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (“high grade lymphoma”) - component
    • Loss of CD20-expression following prior therapy (only to be expected following therapy with rituximab or y90-ibritumomab-tiuxetan)
    • Use of any investigational agent within 28 days prior to initiation of treatment
    • History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years
    • Major surgery, other than diagnostic surgery, within the last 4 weeks
    • Evidence of CNS involvement
    • A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
    • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
    • Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment
    • Inadequate hematological status at baseline prior to study entry:
    Dependency on red blood cell and/or platelet transfusions
    ANC (absolute neutrophil count (segmented + bands) <1.0 x 109/L; platelets <50 x 109/L ; creatinine >2.0 times upper normal limit
    hepatic dysfunction: total bilirubin >1.5 times upper normal limit (unless due to DLBCL involvement of liver or a known history of Gilbert’s disease); ALT >2.5 times upper normal limit (unless due to disease involvement of liver); alkaline phosphatase >2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow)
    • Patients with active opportunistic infections
    • Chronic or current 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
    • 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.
    • Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.
    • Known HIV positivity
    • Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening. pregnancy testing must be performed within 7 days of administration of IMP. GSKs approved methods of birth control must be used
    • Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
    • Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
    • Uncontrolled diabetes mellitus
    • Patients with are hypersensitive to IP.

    E.5 End points
    E.5.1Primary end point(s)
    Rate of objective responses (as judged by best response during the study period)
    → Clinical response measured according to standard criteria (RECIST 1.1, GELA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    •Re-Staging (week 12, 24, 36 & within week 40 -42), including all lesions rated positive for lymphoma involvement at baseline → Assessment via CT scan (chest, abdomen/pelvis), endoscopy with histologic sampling for GI-lymphoma
    E.5.2Secondary end point(s)
    safety & tolerance of treatment in terms of haematologic and non-haematologic side effects as assessed by the investigators.
    → Clinical adverse events & laboratory parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    safety & tolerance of treatment in terms of haematologic and non-haematologic side effects as assessed by the investigators: on day 1 and every 14 days of each cycle, week 40/EOS
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state46
    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)
    none
    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 Decision2013-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-19
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