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    Summary
    EudraCT Number:2017-000614-39
    Sponsor's Protocol Code Number:2016/9408
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-01
    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 ConcernedNorway - NOMA
    A.2EudraCT number2017-000614-39
    A.3Full title of the trial
    Prevention of graft-versus-host disease in patients treated with allogeneic stem cell transplantation: Possible role of extracorporeal photophoresis
    Forebygging av transplantat-mot-vert-sykdom hos pasienter som har gjennomgått stamcelletransplantasjon med bruk av ekstrakorporal fotoforese
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of graft-against-host disease in patients treated with allogeneic stem cell transplantation: Possible role of extracorporeal photophoresis
    Forebygging av transplantat-mot-vert-sykdom hos pasienter som har gjennomgått stamcelletransplantasjon med bruk av ekstrakorporal fotoforese
    A.4.1Sponsor's protocol code number2016/9408
    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 SponsorOSLO UNIVERSITY HOSPITAL HF
    B.1.3.4CountryNorway
    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 supportEXTRASTIFTELSEN
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOSLO UNIVERSITY HOSPITAL
    B.5.2Functional name of contact pointHEAD OF DEPARTMENT
    B.5.3 Address:
    B.5.3.1Street AddressPostbox 4950 Nydalen
    B.5.3.2Town/ cityOSLO
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number4723070713
    B.5.5Fax number4723070470
    B.5.6E-mailgtjonnfj@ous-hf.no
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 20 MCG/ML SOLUTION FOR BLOOD FRACTION MODIFICATION
    D.2.1.1.2Name of the Marketing Authorisation holderTHERAKOS (UK) LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameUVADEX (METHOXSALEN)
    D.3.2Product code 05-3888
    D.3.4Pharmaceutical form Solution for blood fraction modification
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPExtracorporeal use
    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) 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 No
    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
    Graft-versus-host disease (GVHD), both acute and chronic untill one year after allogeneic stam cell transplatation
    Både akutt og kronisk transplantat-mot-vert sykdom i opptil ett år etter stamcelletransplantasjon.
    E.1.1.1Medical condition in easily understood language
    Graft-against-host disease (GVHD), both acute and chronic untill one year after allogeneic stam cell transplatation
    Både akutt og kronisk transplantat-mot-vert sykdom i opptil ett år etter stamcelletransplantasjon.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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
    Reduce graft-versus-host disease
    Redusere transplantat-mot-vert sykdom
    E.2.2Secondary objectives of the trial
    Mortality
    Dødelighet
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients > 18 yrs diagnosed with acute or chronic leukemia, chronic myeloproliferative disease, myelodysplastic syndromes and lymphomas according to WHO-criteria and that are suitable fora first-time allogeneic stem cell transplatation according to our national guidelines.
    -Provide written consent to participate
    -Understand Norwegian or English
    -No previous history of malignant disease
    -No contraindication to ECP-treatment or undergone previous ECP treatment
    Pasienter > 18 år med akutt leukemi, kronisk leukemi, kronisk myeloproliferative sykdom, myelodysplastisk syndrome eller lymfom og trenger allogen stamcelltransplatasjon. De skal tidligere ikke ha hatt annen ondartet sykdom eller gjennomgått ECP behandling. De skal ikke være allergisk mot psoralen eller citrat produkter.
    E.4Principal exclusion criteria
    In addition to those regarding eligibility for transplantation itself:
    -Unwilling to provide written consent to participate
    -Unable to cooperate as judged by the responsible physician
    -ECOG status > 2 at time of inclusion
    -Using anti-inflammatory or cytotoxic drugs other than those that are part of the treatment of the current hematological malignancy
    -Known allergy to psoralen or citrate products
    I tillegg til det som gjelder om deltager er egnet for trasplantasjon
    -Ikke villig til å gi skriftlig samtykke for deltagelse
    -Ikke i stand til å samarbeide vurdert av ansvarlig lege
    -ECOG status > 2 ved inklusjonstiden
    -Bruker betennelsesdempende midler eller cellegift mot andre tilstander enn den aktuelle blodsykdommen
    -Kjent allergi mot psoralen eller citrat produkter
    E.5 End points
    E.5.1Primary end point(s)
    Fraction of graft-versus-host disease
    Andel med transplantat-mot-vert sykdom
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year after start of transplantation
    1 år etter oppstart av transplantasjon
    E.5.2Secondary end point(s)
    Mortality
    Dødelighet
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year after start of transplantation
    1 år etter oppstart av transplantasjon
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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 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
    1 year after the last visit of the last subject
    1 år etter siste besøk/kontroll av siste deltager
    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 months
    E.8.9.1In the Member State concerned days
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state156
    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)
    According to national recommendations regarding treatment of malignant blood diseases

    Etter gjeldende nasjonale anbefalinger som gjelder behandling av ondartet blodsykdommer
    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 Decision2017-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-10
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