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    Summary
    EudraCT Number:2005-003836-22
    Sponsor's Protocol Code Number:114-NH-301
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-03-19
    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 ConcernedLatvia - SAM
    A.2EudraCT number2005-003836-22
    A.3Full title of the trial
    A Phase III, Randomized, 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.4.1Sponsor's protocol code number114-NH-301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGaliximab
    D.3.9.3Other descriptive nameIDEC 114, anti-CD80, anti-B7.1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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 Non-Hodgkin’s Lymphoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10029627
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology intermediate grade refractory
    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.
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be considered for registration and randomization into this study, subjects must satisfy all of the following criteria:
    1. Must give written informed consent and any authorizations as required by local law
    2. Aged ≥18 years old at the time of informed consent
    3. Histologically confirmed follicular Grade 1-3a NHL. If slides and/or tissue blocks
    from the most recent lymph biopsy are not available for Central Pathology Review, a
    repeat lymph node biopsy is required prior to enrollment. If there is any clinical
    evidence suggesting transformation (e.g. elevated LDH >2× upper limit of normal),
    a biopsy is required within 6 months prior to enrollment. Subjects with evidence of
    histologic transformation on a repeat biopsy are excluded from this study.
    4. Relapsed or progressive disease after at least 1 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 protocol Appendix C
    - The presence of B symptoms
    - Bulky disease (at least 1 lesion >5 cm)
    - Laboratory abnormalities (cytopenias)
    - Presence of masses which are causing ongoing clinical symptoms
    5. Bidimensionally measurable disease with at least 1 lesion ≥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 x upper limit of normal (ULN) and ALT (SGPT) ≤ 2 x ULN
    - Serum creatinine ≤ 2.0 mg/dL
    - Hemoglobin ≥ 8.0 g/dL
    - Absolute neutrophil count ≥ 1500 cells/mm3
    - Platelet count ≥ 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 months
    10. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.
    E.4Principal exclusion criteria
    Unless otherwise specified, candidates will be excluded from study entry if any of the
    following exclusion criteria exist at the time of randomization:
    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
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is Progression-Free Survival (PFS).
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Combination of galiximab with rituximab versus placebo and rituximab
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    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
    The purpose of the interim analyses will be to terminate the study early if superiority/futility of the galiximab in combination with rituximab group is demonstrated for progression free survival, the primary efficacy endpoint. A total of 4 analyses
    (3 interim and 1 final) are planned; however, the first interim analysis will be
    exclusively for futility with no stopping for efficacy. An Independent Data Monitoring Committee will monitor safety and efficacy at each interim analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-03-19. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 348
    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 Decision2007-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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