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    Summary
    EudraCT Number:2006-003353-24
    Sponsor's Protocol Code Number:Hx-CD4-110
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-26
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2006-003353-24
    A.3Full title of the trial
    Open-label, Dose escalation, followed by Double-blind, Randomized, Two-dose, Parallel Group, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with Mycosis Fungoides type CTCL (stage IB-IVB) who are Refractory or Intolerant to Targretin® (bexarotene) and one other Standard Therapy
    A.3.2Name or abbreviated title of the trial where available
    HuMax-CD4 in Refractory Mycosis Fungoides
    A.4.1Sponsor's protocol code numberHx-CD4-110
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/198
    D.3 Description of the IMP
    D.3.1Product nameHuMax-CD4 (zanolimumab)
    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.3.10 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 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 Yes
    D.3.11.13.1Other medicinal product typeHuman Monoclonal Antibody
    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
    Refractory Mycosis Fungoides type CTCL (stage IB-IVB).

    The study population will be patients who are refractory to or intolerant to at least two prior therapies, one being Targretin, the other being the current standard of care at each institution.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10028502
    E.1.2Term Mycosis fungoides refractory
    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 is to determine the efficacy of HuMax-CD4 in patients with MF who are refractory or intolerant to treatment with Targretin® and one other standard therapy.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to explore safety and relief of symptoms and characterize the pharmacokinetic profile of HuMax-CD4 in patients with MF who are refractory or intolerant to treatment with Targretin® and one other standard therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) A biopsy compatible with the diagnosis of MF with a CD4 positive phenotype within 6 months of study entry
    2) MF stage IB to IVB (highest stage ever)
    3) Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof), and the other being the current standard therapy at each institution. Stage 1 patients are only required to be refractory or intolerant to at least one prior current standard therapy
    • Refractory is defined as:
    - resistance to therapy due to lack of response (defined as failure to obtain at least a 50% reduction in the disease for at least 6 months)
    - progression of disease (defined as worsening of the disease by 25% or more compared to pre-treatment status) during therapy or within three months after cessation of therapy

    • Intolerance to prior therapy is defined as:
    - Discontinuation of therapy due to side effects/toxicity of the therapy, whether or not response occurred. Side effects/toxicity of Targretin therapy which qualify for the intolerance criteria are isolated hypertriglyceridemia or combined hypertriglyceridemia/hypercholesterolemia despite dose reduction of Targretin and concomitant administration of anti-lipemic therapy, defined as:
    a) Isolated hypertriglyceridemia defined as Triglycerides > 400 mg/d

    b) Combined hypertriglyceridemia/hypercholesterolemia for non-diabetic patients Triglycerides > 200 mg/dL plus LDL cholesterol > 160 mg/dL or Triglycerides > 200 mg/dL plus HDL cholesterol < 40 mg/dL
    c) Combined hypertriglyceridemia/hypercholesterolemia in diabetic patients (type I and II): Triglycerides > 150 mg/dL plus LDL cholesterol > 130 mg/dL or Triglycerides > 150 mg/dL plus HDL cholesterol < 40 mg/dL
    - Other side effects/toxicities of Targretin, despite dose reduction, which qualify for the intolerance criteria:
    d) ALT > 3 times upper limit of normal
    e) AST > 3 times upper limit of normal
    f) Bilirubin > 3 times upper limit of normal
    g) NCI grade 3 leucopenia
    h) Uncorrectable hypothyroidism
    i) Drug related dermatitis
    • Ineligibility (as part of the intolerance criteria) to treatment with Targretin® despite administration of anti-lipemic therapy or due to concurrent medical conditions, such as:
    - Isolated hypertriglyceridemia or combined hypertriglyceridemia/
    hypercholesterolemia, defined as:

    a) Isolated hypertriglyceridemia defined as Triglycerides > 400 mg/dL

    b) Combined hypertriglyceridemia/hypercholesterolemia in non-diabetic patients defined as Triglycerides > 200 mg/dL plus LDL cholesterol > 160 mg/dL or Triglycerides > 200 mg/dL plus HDL cholesterol < 40 mg/dL

    c) Combined hypertriglyceridemia/hypercholesterolemia in diabetic patients (Type I and II): Triglycerides > 150 mg/dL plus LDL cholesterol > 130 mg/dL or Triglycerides > 150 mg/dL plus HDL cholesterol < 40 mg/dL

    - Prior pancreatitis
    - Recurrent biliary colic
    - Known hypersensitivity to retinoids
    - Incapability to swallow Targretin capsules

    4. WHO performance status 0, 1 or 2
    5. Age ≥ 18 years
    6. Following receipt of verbal and written information about the study, the patient must provide signed consent before any study related activity is carried out
    E.4Principal exclusion criteria
    1. Sezary syndrome
    2. Primary cutaneous anaplastic large cell lymphoma
    3. Lymphomatoid papulosis
    4. Histopathological evidence of sheets of large cells (from skin or nodes) or poorly differentiated tumors
    5. Prior treatment with combination chemotherapy within six months
    6. Prior treatment with Total Skin Electron Beam (TSEB) therapy within one year
    7. Prior treatment with Campath (alemtuzumab)
    8. Prior treatment with more than three regimens of single agent chemotherapy
    9. Prior treatment with pentostatin within two years
    10. Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, oral retinoids, systemic glucocorticosteroids, carmustine, nitrogen mustard, systemic vitamin A or etretinate
    11. Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2
    12. Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient’s disease
    13. Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma
    14. Acute or chronic infectious disease (including herpes simplex and herpes zoster) requiring medication except patients taking dicloxillin for carriage of staphylococcus
    15. Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease
    16. Screening blood laboratory values:
    a) Hemoglobin < 8.5 g/dL
    b) WBC ≤ 2.5 x 10^9 cells/L
    c) Platelets < 100 x 10^9 cells/L
    d) ALT/AST > 2.5 times upper limit of normal
    e) S-Creatinine > 1.5 mg/dL
    f) CD3+ CD4+ cell count > 2000 cells/mm^3
    g) CD4/CD8 ratio of 10 or higher
    h) CD4+ CD7– cells ≥ 40% of CD4+ cells
    i) CD4+ CD26– cells ≥ 40% of CD4+ cells
    17. Known or suspected positive serology for HIV
    18. Known or suspected positive serology for hepatitis B or C
    19. Signs or symptoms of CNS involvement
    20. Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening)
    21. Prior treatment with anti-CD4 monoclonal antibodies
    22. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
    23. Breast feeding women or women with a positive pregnancy test at Visit 1
    24. Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate defined as proportion of patients achieving CR, CCR and PR as assessed by Physician’s Global Assessment of Clinical Condition (PGA) during treatment and 8 weeks of follow-up
    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 Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 92
    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 Decision2007-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-16
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