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    Summary
    EudraCT Number:2008-007794-20
    Sponsor's Protocol Code Number:Acute GVHD - ECP
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-05-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-007794-20
    A.3Full title of the trial
    RANDOMIZED CONTROLLED MULTICENTER PHASE II STUDY FOR INITIAL TREATMENT OF ACUTE GRAFT-VERSUS-HOST DISEASE WITH EXTRACORPOREAL PHOTOPHERESIS AND CORTICOSTEROIDS OR CORTICOSTEROIDS ALONE
    A.3.2Name or abbreviated title of the trial where available
    Acute-GVHD-ECP
    A.4.1Sponsor's protocol code numberAcute GVHD - ECP
    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 SponsorAKH Wien, Klinik für Innere Medizin I, Onkologie
    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 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 Yes
    D.2.1.1.1Trade name Uvadex
    D.2.1.1.2Name of the Marketing Authorisation holderJohnson & Johnson Medical Ltd. trading as Therakos Europe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMethoxsalen
    D.3.4Pharmaceutical form Solution for blood fraction modification
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPUnknown use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmethoxsalen
    D.3.9.1CAS number 298-81-7
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 typeThe active ingredient in UVADEX is 8-methoxypsoralen, a naturally occurring photoactive substance found in the seed of the Ammi majus (umbelliferae plant).
    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
    Patients with newly diagnosed acute GVHD grades II to IV
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary endpoint is the complete resolution of GVHD manifestations without additional therapy for GVHD before response is evaluated on day 28 (week 4) after study initiation. Patients who require additional therapy for GVHD in the first 4 weeks after study initiation are considered to be treatment failures for the primary endpoint. Patients who die within the first 4 weeks after start of study regardless of GVHD status at the time of death are also regarded as treatment failures.
    E.2.2Secondary objectives of the trial
    The following secondary endpoints will be assessed and compared between study arms:
    Complete response rate by day 56 and day 84 after study initiation
    Time to complete resolution of acute GVHD to first-line therapy
    Duration of response to first-line therapy of acute GVHD
    Cumulative dose ofsteroids in mg/kg/day from day 0 to days 28 and 56 after study
    initiation
    Time to discontinuation of steroids as first-line therapy of acute GVHD
    Percent of patients in need of secondary treatment for acute GVHD
    Complete response rate to secondary treatment of acute GVHD assessed on day 28
    after start of second-line therapy
    Incidence of bacterial, viral and fungal infections until day 84 and 6 months after
    study initiation
    Incidence of recurrence of malignant disease at 6 months and 12 months after study
    initiation
    Transplant-related mortality at 6 months and 12 months after study initiation
    Overall survival at day 6 months and 12 months after study initiation
    Side effects of ECP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years
    - Patients who develop after allogeneic cell transplantation new onset acute
    GVHD, clinical grades II to IV will be eligible. The diagnosis of GVHD will be made on the basis of clinical features, and confirmed histologically according to standard criteria. (27,28)
    - Treatment for less than 72 hours with 2 mg/kg/day prednisolone prior to
    randomization and first cycle of ECP.
    - Absolute neutrophil count greater than 0.5 X 109/L for at least 3 days.
    Absence of uncontrolled infection.
    - Karnofsky performance score > 50%
    - Signed written informed consent
    - Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control. If a female patient is of childbearing potential, she must have a negative pregnancy test prior to study entry and in monthly intervals thereafter.
    - Patients must be able and willing to comply with all study procedures.
    E.4Principal exclusion criteria
    - Patients who have received more than one prior allogeneic BMT or PBSCT
    - Patients who received donor lymphocyte infusions (DLI)
    - Patients who have a known hypersensitivity or allergy to 8-methoxypsoralen
    - Patients with uncontrolled infections at onset of acute GVHD.
    -Patients with serious hemorrhage and/or gastrointestinal bleeding
    - Patients who had previous treatment with ECP.
    - Patients who received treatment with prednisolone for > 72 hours.
    - Patients unable to tolerate removal of > 500 ml of circulating blood volume required for the ECP procedure.
    - Patients with a platelet count < 20 X 109/L despite platelet transfusions.
    - Poor likelihood of full cooperation in the study and/or poor compliance anticipated.
    - Patients with a serious psychiatric disorder.
    - Patients who are currently participating in another study
    - Patients with co-existing melanoma, basal cell or sequamous cell skin carcinoma
    - Pregnant or lactating patients
    - Patients with aphakia
    - Patients with photosensitive disease like porphyria, systemic lupus erythematosus or albinism
    - Patients with coagulation disorders
    - Patients with uncontrolled acute systemic viral infection
    - Patients who have a known hypersensitivity or allergy to Prednisolon or other content of Decortin-H
    - Patients with HBs antigen positive active chronic hepatitis B infection
    - Patients who received vaccine within previous 2 weeks
    - Patients with lymphadenitis following BCG vaccine
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the complete resolution of GVHD manifestations without additional therapy for GVHD before response is evaluated on day 28 (week 4) after study initiation. Patients who require additional therapy for GVHD in the first 4 weeks after study initiation are considered to be treatment failures for the primary endpoint. Patients who die within the first 4 weeks after start of study regardless of GVHD status at the time of death are also regarded as treatment failures.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.2Open No
    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
    Standardtherapy
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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 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 2010-05-03. 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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 Decision2010-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-30
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