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    Summary
    EudraCT Number:2012-000212-28
    Sponsor's Protocol Code Number:M-PUVA2012
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-000212-28
    A.3Full title of the trial
    A multi-center, randomized study on oral 8-methoxypsoralen plus UVA with or without maintenance therapy in mycosis fungoides EORTC/ISCL stage Ia to IIb.
    Eine multizentrische, randomisierte , klinische Studie mit oder ohne PUVA -Erhaltungstherapie mit 8-MOP bei Patienten mit Mycosis fungoides Stadium IA bis IIB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center, randomized clinical trial with or without PUVA (= psoralen, a photosensitizing agent, + UVA treatment) maintenance therapy in patients with mycosis fungoides (= kind of skin cancer).
    Eine multizentrische, randomisierte (= zufällige Zuteilung zu den Behandlungsgruppen) , klinische Studie mit oder ohne PUVA -Erhaltungstherapie (= Psoralen, ein photosensibilisierender Wirkstoff, plus UV-Bestrahlung) bei Patienten mit Mycosis fungoides (= Form von Hautkrebs)
    A.4.1Sponsor's protocol code numberM-PUVA2012
    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 SponsorMedizinische Universität Graz, Univ. Klinik für Dermatologie
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedizinische Universität Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointInformation Klinische Studie
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 8
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number43316385 12538
    B.5.5Fax number43316385 12466
    B.5.6E-maildermatologie@medunigraz.at
    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 Yes
    D.2.1.1.1Trade name Oxsoralen
    D.2.1.1.2Name of the Marketing Authorisation holderGerot Pharmazeutika GesmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN8-Methoxypsoralen
    D.3.9.1CAS number 298-81-7
    D.3.9.3Other descriptive namePsoralen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 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
    mycosis fungoides
    Mycosis Fungoides
    E.1.1.1Medical condition in easily understood language
    kind of skin cancer
    Form von Hautkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10028503
    E.1.2Term Mycosis fungoides stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10028504
    E.1.2Term Mycosis fungoides stage II
    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 determine whether PUVA maintenance therapy does prolong disease free survival after initial complete response.
    Es soll untersucht werden, ob die Erhaltungstherapie das Auftreten des Rezidivs verhindert bzw. das Zeitintervall bis zum Auftreten des Rezidivs verlängert.

    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histopathologically documented MF clinical stage IA-IIB (see Table1) confirmed by current or previous diagnostic lesion biopsy
    • A Karnofsky performance score > 60 (see Table 2)
    • Age > 18 years - ≤ 85
    • Anti-ds-DNA (antinuclear antibodies) AND anti-Ro/La antibodies: negative
    • Acceptable organ function defined as follows:
    SGOT (AST) and SGPT (ALT) < 2.5 times the upper limit of normal for the institution
    • Creatinine < 2 times the upper limit of normal for the institution
    • No evidence of severe cardiac insufficiency (NYHA grade III-IV)
    • Women of child bearing potential must have a negative serum or urine pregnancy test (ß-HCG) within seven (7) days prior to randomization
    • Absence of any serious intercurrent illness or infection at time of entry into the study that could interfere with planned treatment
    • Patients must be willing to accept limiting sun exposure on the day receiving PUVA treatment
    • Written informed consent
    E.4Principal exclusion criteria
    • Pregnancy and Lactation

    • Photosensitive diseases such as lupus erythematosus or basal cell nevus syndrome

    • Skin cancer syndromes such as Xeroderma pigmentosum or basal cell nevus syndrome

    • PUVA (oral or topical) treatment within the last 3 months
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of median time to recurrence after complete remission between patients treated with maintenance therapy vs. patients without maintenance therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    timepoint: up to five years after the end of treatment
    E.5.2Secondary end point(s)
    Comparison of time from end of treatment to recurrence on condition that the patient is in complete remission at the end of treatment between patients treated with maintenance therapy vs. patients without maintenance therapy.
    - Cytokine response in serum and tissue

    - Quality of life

    - HADS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Comparison of time from end of treatment to recurrence on condition that the patient is in complete remission at the end of treatment between patients treated with maintenance therapy vs. patients without maintenance therapy.

    Cytokine response in serum and tissue:
    before start of treatment, week 6 and 12 and two optional timepoints. During maintenance therapy: week 24 and end of maintenance therapy

    Quality of life and HADS: each follow-up exam
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    no maintenance therapy
    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 concerned10
    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 No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 66
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state82
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 82
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    normal treatment
    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 Decision2012-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-02
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