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    The EU Clinical Trials Register currently displays   44173   clinical trials with a EudraCT protocol, of which   7329   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2019-004566-17
    Sponsor's Protocol Code Number:EORTC-1820-CLTG
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-23
    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 - PEI
    A.2EudraCT number2019-004566-17
    A.3Full title of the trial
    Open-Label, phase II, Multi-Center, study of Anti-CCR4 Monoclonal Antibody (mogamulizumab) Plus Total Skin Electron Beam therapy (TSEB) in patients with stage IB-IIB Cutaneous T-Cell Lymphoma
    Offene, multizentrische Phase-II-Studie zum monoklonalen Anti-CCR4-Antikörper (Mogamulizumab) plus Ganzhaut-Elektronenstrahltherapie (TSEB) bei Patienten mit kutanem T-Zell-Lymphom im Stadium IB oder IIB (MOGAT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study of a monoclonal antibody, mogamulizumab, associated with radiotherapy called total skin electron beam (TSEB), in patients with cutaneous T-cell lymphoma
    Phase-II-Studie zum monoklonalen Antikörper, Mogamulizumab zusammen mit Strahlentherapie, bezeichnet als Ganzhaut-Elektronenstrahltherapie (Total Skin Electron Beam, TSEB), bei Patienten mit kutanem T-Zell-Lymphom
    A.3.2Name or abbreviated title of the trial where available
    MOGAT
    A.4.1Sponsor's protocol code numberEORTC-1820-CLTG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04128072
    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 SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 supportEuropean Organisation for the Research and Treatment of Cancer
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportKyowa Kirin
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for the Research and Treatment of Cancer
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street Address83/11 Avenue E. Mounier
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+322774 15 40
    B.5.5Fax number+322772 70 63
    B.5.6E-mailregulatory@eortc.org
    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 POTELIGEO
    D.2.1.1.2Name of the Marketing Authorisation holderKyowa Kirin Holdings B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1756
    D.3 Description of the IMP
    D.3.1Product nameKW-0761 (Mogamulizumab)
    D.3.2Product code KW-0761
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNMogamulizumab
    D.3.9.1CAS number 1159266-37-1
    D.3.9.2Current sponsor codeKW-0761
    D.3.9.3Other descriptive nameMOGAMULIZUMAB
    D.3.9.4EV Substance CodeSUB85518
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Cutaneous T-cell lymphoma (Mycosis Fungoides (MF) and Sézary Syndrome (SS))
    E.1.1.1Medical condition in easily understood language
    Cutaneous T-cell lymphoma, a category of cancers of lymphocytes (a type of white blood cells) that primarily involve the skin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028502
    E.1.2Term Mycosis fungoides refractory
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028504
    E.1.2Term Mycosis fungoides stage II
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028503
    E.1.2Term Mycosis fungoides stage I
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028508
    E.1.2Term Mycosis fungoides/Sezary syndrome
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028511
    E.1.2Term Mycosis fungoides/Sezary syndrome refractory
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028512
    E.1.2Term Mycosis fungoides/Sezary syndrome stage I
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028513
    E.1.2Term Mycosis fungoides/Sezary syndrome stage II
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025321
    E.1.2Term Lymphomas non-Hodgkin's T-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the progression free survival rate at 48 weeks (according to EORTC-ISCL-USCLC criteria) of anti-CCR4 monoclonal antibody (mogamulizumab) and TSEB in IB-IIB cutaneous T-cell lymphoma.
    Das Hauptziel besteht darin, die progressionsfreie Überlebensrate nach 48 Wochen (gemäß EORTC-ISCL-USCLC-Kriterien) des monoklonalem Anti-CCR4-Antikörpers (Mogamulizumab) und Ganzhaut-Elektronenstrahltherapie (Total Skin Electron Beam therapy,TSEB) bei kutanem IB/IIB-T-Zell-Lymphom zu bestimmen.
    E.2.2Secondary objectives of the trial
    • To evaluate the overall safety
    • To assess the response rate
    • To assess the progression-free survival
    • To assess the overall survival
    • To assess the time to progression
    • To evaluate the duration of response
    • To evaluate the time to next significant treatment
    • Beurteilung der Gesamtsicherheit
    • Beurteilung der Ansprechrate
    • Beurteilung des progressionsfreien Überlebens
    • Beurteilung des Gesamtüberlebens
    • Beurteilung der Zeit bis zur Progression
    • Beurteilung der Dauer des Ansprechens
    • Beurteilung der Zeit bis zur nächsten signifikanten Behandlung
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Males and female subjects ≥ 18 years;
    • Mycosis fungoides stage IB, IIA, IIB;
    • Subjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy;
    • Adequate haematological and organ function;
    • Signed informed consent
    • Männliche und weibliche Patienten ≥ 18 Jahre
    • Mycosis fungoides Stadium IB, IIA, IIB
    • Patienten, bei denen mindestens eine vorherige systemische Therapie versagt hat. Psoralen plus UV-Licht-Therapie (PUVA) gilt nicht als systemische Therapie
    • Adäquate hämatologische und Organfunktionen
    • Unterschriebene Einwilligungserklärung
    E.4Principal exclusion criteria
    • Prior treatment with mogamulizumab;
    • Prior TSEB;
    • Known hypersensitivity to CHO cell products or any component of the mogamulizumab formulation;
    • Significant uncontrolled intercurrent illness
    • Vorherige Behandlung mit Mogamulizumab
    • Vorherige TSEB
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival Rate at 48 weeks (PFSR-48)
    Progressionsfreie Überlebensrate nach 48 Wochen (PFSR-48)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 48 weeks after start of mogamulizumab for each patient
    Bis zu 48 Wochen nach Beginn der Behandlung mit Mogamulizumab für jeden Patienten
    E.5.2Secondary end point(s)
    • Overall safety of both mogamulizumab and TSEB;
    • Response rate (RR) to both mogamulizumab and TSEB ;
    • Progression-free survival (PFS) ;
    • Overall survival (OS);
    • Time to progression ;
    • Duration of response ;
    • Time to next treatment.

    Exploratory endpoints:
    Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure.
    • Gesamtsicherheit von beidem, von Mogamulizumab und TSEB Behandlung
    • Ansprechrate auf beides, auf Mogamulizumab und TSEB
    • Progressionsfreies Überleben
    • Gesamtüberleben
    • Zeit bis zur Progression
    • Dauer des Ansprechens
    • Zeit bis zur nächsten Behandlung
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Overall safety: 48 months after last patient in;
    • RR: from the first patient treatment start till 48 weeks as of last patient in;
    • PFS: from the first patient treatment start till 48 weeks as of last patient in;
    • OS: from the first patient treatment start till 5 years after last patient treatment;
    • Time to progression: from the first patient treatment start till 48 weeks as of last patient in;
    • Duration of resp: from the first patient treatment start till 48 weeks as of last patient in;
    • Time to next treatment: from the first patient treatment start till 48 weeks as of last patient in.
    • Gesamtsicherheit von Mogamulizumab und TSEB : 48 Monate nach der letzten Patientenaufnahme
    • Ansprechrate auf Mogamulizumab und TSEB: Ab Beginn der ersten Patientenbehandlung bis 48 Wochen ab dem zuletzt aufgenommenen Patienten
    • Progressionsfreies Überleben: Ab Beginn der ersten Patientenbehandlung bis 48 Wochen ab dem zuletzt aufgenommenen Patienten
    • Gesamtüberleben: Ab dem Beginn der Behandlung des ersten Patienten bis 5 Jahre nach der Behandlung des letzten Patienten
    • Zeit bis zur Progression, dauer des Ansprechens und zeit bis zur nächsten Behandlung: Ab Beginn der ersten Patientenbehandlung bis 48 Wochen ab dem zuletzt aufgenommenen Patienten
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Radiotherapy, Biobanking, Quality of Life
    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.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    Denmark
    France
    Germany
    Greece
    Italy
    Spain
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Ninety days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 21
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 43
    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)
    After progression, the treatment will be left to the discretion of the treating physician
    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 Decision2021-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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