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    Summary
    EudraCT Number:2004-000243-23
    Sponsor's Protocol Code Number:Hx-CD4-109
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-09-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-000243-23
    A.3Full title of the trial
    An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with refractory or relapsed Non-Cutaneous CD4+ T-Cell Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
    A.4.1Sponsor's protocol code numberHx-CD4-109
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 Information not present in EudraCT
    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 nameHuMax-CD4
    D.3.2Product code HuMax-CD4
    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.3.8INN - Proposed INNzanolimumab
    D.3.9.1CAS number 652153-01-0
    D.3.9.2Current sponsor codeHuMax-CD4
    D.3.9.3Other descriptive namefully human monoclonal antibody against CD4 on T-cells
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Yes
    D.3.11.13.1Other medicinal product typeFully human monoclonal antibody
    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
    The mature non-cutaneous T-cell lymphomas expressing the CD4 molecule are the object of this protocol.
    1.Peripheral T-cell lymphoma (PTCL) unspecified
    2.Angioimmunnoblastic T-cell lymphoma
    3.Anaplastic large cell lymphoma
    4.Enteropathy type T-cell lymphoma
    5.Hepatosplenic T-cell lymphoma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10042971
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to explore the efficacy of HuMax-CD4 treatment with respect to tumor response and duration in patients with refractory or relapsed non-cutaneous CD4+ T-cell lymphoma.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety of HuMax-CD4 treatment in patients with refractory or relapsed non-cutaneous CD4+ T-cell lymphoma.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Patients must have a diagnostic biopsy of non-cutaneous T-cell lymphoma with a CD4 positive phenotype. The biopsy must be performed within 6 months of first treatment. Patients must be diagnosed according to one of the following subgroups by histological subtypes as defined by WHO:
    • Peripheral T-cell lymphoma (PTCL) unspecified
    • Angioimmunnoblastic T-cell lymphoma
    • Anaplastic large cell lymphoma
    • Enteropathy type T-cell lymphoma
    • Hepatosplenic T-cell lymphoma
    2. Relapse or refractory to at least one prior chemotherapy. Refractory is defined as resistance to therapy due to lack of response or progression of disease. The relapse must be histologically confirmed. The histology should be determined through an excisional lymph node biopsy. In case this is not feasiable due to different standard practice or not possible in case of more deeply located etc. a core biopsy can be performed.
    3. CT scan at screening showing:
    a) 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
    b) 1 clearly demarcated lesion of a largest diameter ≥ 2.0 cm
    c) For patients with PTCL, hepatosplenic type, liver and/or spleen must be enlarged and the case must be immunohistochemically confirmed as being CD4-positive.
    d) For patients with PTCL, enteropathy type, a bioptic verification with immunohistochemically confirmed CD4-positivity must also be present.
    4. Age ≥18
    5. Following receipt of verbal and written information about the trial, the
    patient must provide signed consent before any trial related activity is
    carried out.
    E.4Principal exclusion criteria
    1) Prior treatment with anti-CD4 monoclonal antibodies.
    2) Treatment with CdA , fludarabine or Campath® within the previous year.
    3) Treatment within 4 weeks prior to visit 2 with systemic anticancer therapies, such as, but not limited to: methorexate, bleomycin, cyclophosphamide, systemic glucocorticosteroids.
    4) Relapse after more than two previous lymphoma treatment regimens (high dose consolidation is not regarded as a regimen itself).
    5) Leukemia.
    6) Life expectancy less then 6 months.
    7) WHO performance status ≥ 3
    8) Concurrent or previous malignancies within the past 5 years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin cercinoma.
    9) Acute or chronic infectious disease requiring systemic medication.
    10) Significant concurrent, uncontrolled or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease.
    11) Screening laboratory values
    i. Hemoglobin < 5.3 mmol/L (<8.7 g/dL)
    ii. WBC ≤2.5 x 109 cells/L
    iii. Neutrophils< 1.5 x 109cells/L
    iv. Platelets < 75 x 109 cells/L
    v. CD3+CD4+ cell count > 2000 cells/mm3
    vi. ALT/AST > 4 times upper limit of normal, unless lymphoma related
    vii. S-creatinine greater than 133 µmmol/L
    12) Known or suspected positive serology for HIV.
    13) Allogenic bone marrow transplantation.
    14) Known or clinical suspicion for CNS involvement.
    15) Breast-feeding women or women with a positive pregnancy test at visit 1.
    16) Women of childbearing potential not using either hormonal birth control or an intrauterine device for the entire trial period.
    17) Simultaneous or previous participation in a trial with any investigational drug within 4 weeks prior to start of trial treatment.
    18) Patients known or suspected of being not able to comply with the requirements of the trial (e.g due to alcoholism, drug dependency or psychological disorder).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is objective tumor response from start of treatment until week 18.
    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 No
    E.6.7Pharmacodynamic No
    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 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 Yes
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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 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
    Last patient last visit eg. 24 months after last treatment or until disease progression.




    First patient in: October 2004, expected last patient out in approx. April 2007
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=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 2004-09-27. Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    Women of childbearing potential not using either hormonal birthcontrol or an intrauterine device for the entire study period are excluded for the trial. This is one of the exclusion criteria.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 20
    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 Decision2004-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-09
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