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    Summary
    EudraCT Number:2006-004516-51
    Sponsor's Protocol Code Number:27056
    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:2007-05-17
    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 number2006-004516-51
    A.3Full title of the trial
    A multicentre open-label, dose-escalation, trial of zanolimumab in combination with CHOP chemotherapy in subjects with CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement
    A.3.2Name or abbreviated title of the trial where available
    Zanolimumab with CHOP in CD4+ non-cutaneous PTCL with nodal involvment
    A.4.1Sponsor's protocol code number27056
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorSERONO INTERNATIONAL SA
    B.1.3.4CountryItaly
    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 namezanolimumab
    D.3.4Pharmaceutical form 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 codeHuMax-CD4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CD4 positive non cutaneous peripheral T-Cell lymphoma with nodal involvement
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10034623
    E.1.2Term Peripheral T-cell lymphoma unspecified
    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 safety and tolerability of ascending doses of zanolimumab up to 20 mg/kg in combination with CHOP chemotherapy in order to define a maximum tolerated dose (MTD) in subjects with CD4 positive non-cutaneous peripheral T-Cell Lymphoma with nodal involvement
    E.2.2Secondary objectives of the trial
    - Assess the pharmacokinetic (PK) profile of zanolimumab and doxorubicin when zanolimumab is administered concomitantly with CHOP; - Assess pharmacodynamic (PD) parameters in order to look for associations with PK, tolerability and efficacy signals. Tumore metabolic activity will be measured in a subset of subjects (centers with PET scanners) - Investigate efficacy signals (CR, CRu, PR) - Investigate host immune response to zanolimumab administration - To explore changes in CD4 positivity in subjects with biopsy for progressive disease
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Non-cutaneous peripheral T-cell lymphoma, with nodal involvement, with a CD4 positive phenotype confirmed by biopsy that must be performed within 2 months of Screening (node involvement must be accessible and measurable) excluding ALK + ALCL 2. Subjects must be eligible for the CHOP chemoterapy regimen. 3. Subjects may have had no more than one previous chemotherapy, excluding anthracyclines, and must have been in remission ofr at least one year. 4. Measurable disease according to the Standardized Response Criteria for NHL 5. Age major/equal 18 years 6. Has read and understands and has signed the informed consent (or has a legally acceptable representative who has signed on theri behalf) 7. Subjects and their partners will be requested to use medically approved contraception (e.g. intra-uterine device, diaphragm, condom with spermicides, contraceptive medication) from signature of informed consent until 8 weeks after the end of the last 3-week Cycle of CHOP. Exception: women who are psotmenopausal for more than 2 years; subjects who are surgically sterile or have a partner who is surgically sterile. 8. ECOG performance status minor/equal 2.
    E.4Principal exclusion criteria
    1. Known or suspected hypersensitivity to CHOP or components of the IMP 2. Known infection with HIV, unresolved hepatitis C (HCV RNA + in plasma) or hepatitis B (HBV DNA+, HBs Ag+, HBc Ag+), signs and symptoms of transmissible spongiform encepalopathy 3. Other concurrent or previous malignancies within the past 5 years, except adequately treated in situ carcinoma of the uterine cervix or basal cell carcinoma 4. Significant concurrent, uncontrolled or active medical condition including, but not limited to acute or chronic infectious disease requiring systemic medication renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease. 5. Known or clinical suspicion for CNS involvement of the PTCL with nodal involvement 6. Severe bone marrow impariment as evidenced by Hemoglobin (Hb) < 9.0 g/dL, asbolute neutrophil count (ANC) < 0.5 x 109/l, plateletes < 20 x 109/l at Screening 7. Subjects having received extensive radiotherapy (involving major/equal 30% of bone marrow) within the last 2 years 8. Renal impairment as evidenced by serum creatinine > 1.5 x upper limit of normal (ULN), and/or calculated creatinine clearance < 60 ml/min at Screening. 9. Liver function abnormality as defined by total bilirubin > 1.5 ULN and/or AST/ALT > 2.5 x ULN or for subjects with liver involvement AST/ALT > 5 x ULN 10. INR > 1.5 x ULN at Screening 11. Breast-feeding woment or women with a positive pregnancy test at Screening 12. Any immunosuppressive or cytotoxic drugs within 3 months from Screening (e.g. drugs interfering with the functions of T cell, IL-2, etc) 13. Prior treatment with anti-CD4 monoclonal antibodies within one year prior to Screening
    E.5 End points
    E.5.1Primary end point(s)
    The number of subjects experiencing a Dose-Limiting Toxicity related to study drug during the first Cycle of CHOP in each cohort
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 No
    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.8.3 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.8.6 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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2006-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-12-02
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