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    Summary
    EudraCT Number:2005-003836-22
    Sponsor's Protocol Code Number:114-NH-301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-01-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-003836-22
    A.3Full title of the trial
    A phase III, randomised, double blind study of galiximab in combination with rituximab compared with rituximab in combination with placebo for the treatment of subjects with Relapsed or Refractory, follicular Non-Hodgkin's Lymphoma
    A phase III, randomised, double blind study of galiximab in combination with rituximab compared with rituximab in combination with placebo for the treatment of subjects with Relapsed or Refractory, follicular Non-Hodgking`s Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    114-NH-301
    A.4.1Sponsor's protocol code number114-NH-301
    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 SponsorBiogen Idec Ltd.
    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 namegaliximab
    D.3.2Product code NA
    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 INNgaliximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number500
    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 typeNon Applicabile
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or refractory follicular NHL
    Linfoma Non Hodgin follicolare recidivante o refrattario al trattamento
    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 10016905
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III 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 compare the clinical benefit of galiximab in combination with rituximab with that of rituximab monotherapy for the treatment of subjects with relapsed or refractory, follicular NHL.
    Confrontare i benefici clinici di galiximab in associazione a rituximab con quelli della monoterapia di rituximab per il trattamento di soggetti con LNH follicolare recidivante o refrattario al trattamento
    E.2.2Secondary objectives of the trial
    · To further characterize the safety profile of galiximab in combination with rituximab. · To further characterize the pharmacokinetics (PK) of 4 infusions of galiximab in combination with rituximab.
    - caratterizzare ulteriormente il profilo di sicurezza di galiximab in associazione con rituximab- caratterizzare ulteriormente la farmacocinetica di 4 infusioni di galiximab in associazione con rituximab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must give written informed consent and any authorizations as required by local law (e.g., Protected Health Information [PHI] for North America) 2. Aged ³ 18 years old at the time of informed consent 3. Histologically confirmed follicular NHL Grade 1-3a (if the subject has received any intervening lymphoma therapy since the most recent biopsy, a repeat biopsy will be required to exclude transformation) 4. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment as determined by one of the following: · Documented disease progression by CT scan using the International Workshop Response Criteria (IWRC) as described in Appendix C on the protocol · The presence of B symptoms · Bulky disease (at least 1 lesion >5 cm) · Laboratory abnormalities (cytopenias or elevated LDH) · Presence of masses which are causing ongoing clinical symptoms 5. Bidimensionally measurable disease with at least 1 lesion ³ 2.0 cm in a single dimension 6. Hematologic, hepatic, and renal function parameters satisfying the following: · Bilirubin £ 2.0 mg/dL · AST (SGOT) £ 2 ´ upper limit of normal (ULN) and ALT (SGPT) £ 2 ´ ULN · Serum creatinine £ 2.0 mg/dL · Hemoglobin ³ 8.0 g/dL · Absolute neutrophil count ³ 1500 cells/mm3 · Platelet count ³ 75,000 plts/mm3 7. WHO Performance Status £ 2 8. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs 9. Expected survival of ³ 3 months 10. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.
    - Consenso informato firmato - aver compiuto 18 anni al momento della firma del consenso informato - LNH follicolare di grado 1-3a confermato istologicamente
    E.4Principal exclusion criteria
    1. Follicular lymphoma Grade 3b 2. Previous exposure to galiximab or any anti CD80 antibody 3. Known hypersensitivity to murine proteins 4. Rituximab refractory or refractory to anti CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months) 5. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C) 6. Prior lymphoma vaccine therapy within 12 months prior to Study Day 1 7. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1 8. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1 9. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1 10. Prior allogeneic transplant 11. Transfusion-dependent subjects 12. Known history of hepatitis or hepatic disease. (Although testing for hepatitis B is not mandatory, this should be considered for all subjects considered at high risk for hepatitis B infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B exposure should be excluded unless the serological findings are clearly due to vaccination.) 13. Presence of chronic lymphocytic leukemia (CLL), marginal zone lymphoma, mucosa associated lymphoid tissue (MALT) 14. Presence of central nervous system (CNS) lymphoma 15. Known history of HIV infection or AIDS 16. Prior diagnosis of aggressive NHL or mantle cell lymphoma 17. Histologic transformation 18. Presence of pleural or peritoneal effusion with positive cytology for lymphoma 19. Another primary malignancy requiring active treatment (except hormonal therapy) 20. Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor 21. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1 22. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1 23. History of alcoholism or substance abuse within the 2 years prior to Study Day 1 24. Pregnant or currently breastfeeding
    - Linfoma follicolare di grado 3b - pecedente esposizinone a galiximab o anticorpi anti CD80 - ipersensibilita` nota alle proteine muriniche - refrattario a rituximab o ad anticorpi anti CD20
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival
    Sopravvivenza libera da progressione
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned16
    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 Information not present in EudraCT
    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
    Il follow up dopo i primi 4 anni continuera' in uno stusdio separato dal presente, fino a morte del paziente, perdita del follow up o ritiro del Consenso informato
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 700
    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 Decision2007-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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