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    Summary
    EudraCT Number:2019-000894-22
    Sponsor's Protocol Code Number:MAGIC-HR-ECP
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-000894-22
    A.3Full title of the trial
    Phase II multicenter study of extracorporeal photopheresis with UvadexTM plus standard steroid treatment for high risk acute Graft-versus-Host Disease
    Multizentrische Phase II Studie zur Behandlung von Hochrisikoakuter Graft-versus-Host Erkrankung mit extrakorporaler Photopherese mit UvadexTM zusätzlich zur Standardbehandlung mit Steroiden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II multicenter study of UV irradiation with UvadexTM outside of the body plus standard steroid treatment for high risk acute Graft-versus-Host Disease
    Multizentrische Phase-II-Studie zur UV-Bestrahlung mit UvadexTM außerhalb des Körpers plus Standardbehandlung mit Steroiden bei akuter Spender-gegen-Empfänger-Erkrankung mit hohem Risiko
    A.4.1Sponsor's protocol code numberMAGIC-HR-ECP
    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 SponsorDepartment of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf
    B.1.3.4CountryGermany
    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 supportTherakos, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf
    B.5.2Functional name of contact pointFrancis A. Ayuk
    B.5.3 Address:
    B.5.3.1Street AddressMartinistraße 52
    B.5.3.2Town/ cityHamburg
    B.5.3.4CountryGermany
    B.5.4Telephone number004940741055250
    B.5.6E-mailayuketan@uke.de
    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 holderTherakos Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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
    New onset high risk acute GvHD following allogeneic SCT
    Neu auftretende akute GvHD mit hohem Risiko nach allogener SCT
    E.1.1.1Medical condition in easily understood language
    New onset high risk acute Graft-versus-Host-Disease following allogeneic (of nonself origin) Stem Cell Transplantation
    Neu auftretende akute Spender-gegen-Empfänger-Erkrankung mit hohem Risiko nach Transplantation von Stammzellen, die nicht vom Patienten selbst stammen
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018653
    E.1.2Term Graft-versus-host disease <GVHD>
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To improve day 28 GvHD complete response rate for high risk (Ann Arbor Score 2/3) GvHD patients from the historical rate of 37% to 52% by treatment with ECP and high dose systemic corticosteroids (2 mg/kg).
    Verbesserung der GvHD-Gesamtansprechrate am Tag 28 bei Hochrisiko-GvHD-Patienten (Ann Arbor Score 2/3) von bisher 37% auf 52% durch Behandlung mit ECP und hochdosierten systemischen Kortikosteroiden (2 mg / kg).
    E.2.2Secondary objectives of the trial
    To decrease 6-month NRM from the historical rate of 30% to 20% in patients treated on this clinical trial.
    Verringerung der 6-Monats-NRM von der historischen Rate von 30% auf 20% bei Patienten, die in dieser klinischen Studie behandelt werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. New onset high risk acute GvHD (Ann Arbor score 2/3 as defined in Appendix A) following allogeneic SCT. Any clinical severity (Glucksberg grade I-IV) is eligible.
    2. Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). Recipients of non-myeloablative and myeloablative transplants are eligible.
    3. No prior systemic treatment for acute GvHD except for a maximum of 7 days of methylprednisolone ≤2 mg/kg/day (or IV Methyprednisolone equivalent) during the period from the initiation of systemic steroid treatment for acute GvHD until study therapy begins. Topical skin steroid treatment and non-absorbable oral steroid treatment for GI GvHD are permissible.
    4. Age 18 years or older.
    5. Platelet count > 25.000 (including platelet support)
    6. Eastern Coorperative Oncology Group (ECOG) score of 0≤2 unless due to aGvHD
    7. Negative pregnancy test within 10 days before start of study if the patient is a woman of child-bearing age
    8. Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome or aGvHD within 3 days before screening.
    9. ALT/SGPT and AST/SGOT must be <5 x the upper limit of the normal range within 3 days before screening.
    10. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol (see section 11).
    11. Written informed consent from patient.
    12. Biopsy of acute GvHD target organ is strongly recommended but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not start ECP within 5 working days of initiation of systemic steroid treatment for acute GvHD are not permitted to par-ticipate.
    E.4Principal exclusion criteria
    1. Progressive or relapsed malignancy
    2. Uncontrolled active infection
    3. Patients with chronic GvHD
    4. History of or current diagnosis of progressive multifocal leu-koencephalopathy (PML)
    5. Pregnant or nursing (lactating) women
    6. Use of other drugs for the treatment of acute GvHD apart from on-going GvHD prophylaxis and corticosteroids
    7. Patients on dialysis
    8. Patients requiring ventilator support
    9. Evidence of known infection with human immunodeficiency virus (HIV) or active hepatitis B
    10. Investigational agent within 30 days of enrollment without approval from the Sponsor-Investigator (PI). (Off-label use of medication is not considered investigational unless in context of a formal study)
    11. History of allergic reaction to 8-MOP
    12. Concomitant diagnosis of malignant melanoma or basal cell carci-noma
    13. Hypersensitivity or allergy to both heparin and citrate products (if hypersensitive or allergic only to one, exclusion does not apply)
    14. Inability to tolerate extracorporeal volume shifts associated with ECP
    15. Presence of aphakia
    16. History of splenectomy
    17. Leucocyte count > 25.000/ul
    18.Coagulopathy
    19. Known photosensitive disease like systemic lupus erythematosus, porphyrias or albinism
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this clinical study is the proportion of complete response (that is, the per-cent of patients with skin, liver, and GI GvHD all stage 0) at day 28 of study treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 28 of study treatment
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    1. Overall survival at 1 year
    2. Cumulative incidence of NRM at 6 months and at 1 year
    3. Overall response rate (CR + PR) at day 28 and 56. PR is defined as improvement in one or more organs involved with GvHD symptoms without progression in others. For a response to be scored as PR on day 28 or 56, the patient must be in PR on day 28 or 56 and have had no intervening non-study therapy for acute GvHD.
    4. Cumulative incidence of treatment-refractory GvHD (defined as ab-sence of CR or PR on day 28 of treatment or who receive additional immunosuppression prior to day 28)
    5. Cumulative incidence of severe GI GvHD stage 3 or 4
    6. Time to discontinuation of steroid therapy
    7. Number of lines of GvHD therapy (defined as the initiation of a new acute GvHD therapy, regard-less of duration)
    8. Cumulative incidence of chronic GvHD
    9. Number of serious infections (defined as grade 3 by the Blood and Marrow Transplant Clinical Trials Network)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - on days 28 and/or 56
    - Overall survival after 1 year
    - Cumulative incidence of NRM at 6 months and at 1 year
    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 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 No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    last follow-up visit of the last patient
    letzter Kontrollbesuch des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    Long-term follow-up is provided as part of the routine treatment. After leaving the clinical trial, the attending physician will discuss and determine the further treatment options with the subject. The patient receives corresponding information from the medical staff of the clinic or the outpatient clinic, e.g. how, when and by whom the treatment is continued.
    Es erfolgt eine langfristige Nachsorge im Rahmen der Routinebehandlung. Nach Ausscheiden aus der klinischen Prüfung wird der behandelnde Arzt mit dem Prüfungsteilnehmer die weiteren Therapieoptionen besprechen und festlegen. Der Patient erhält entsprechende Informationen vom ärztlichen Personal der Station bzw. der Ambulanz der Klinik z.B. wie, wann und durch wen die Behandlung fortgeführt wird.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Mount Sinai Acute GVHD International Consortium - MAGIC
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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