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    Summary
    EudraCT Number:2020-004698-30
    Sponsor's Protocol Code Number:2020-42
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004698-30
    A.3Full title of the trial
    Efficacy and Safety of Cytotect®CP, hyperimmune anti-CMV IVIg as CMV prophylaxis in patients developing acute grade II-IV GVHD after allogeneic hematopoietic cell transplantation A prospective phase II study.
    Étude multicentrique, prospective, de phase II – CMV-GVHD –évaluant L’efficacité et innocuité du Cytotect®CP, un IVIg hyperimmune anti-CMV comme prophylaxie contre le CMV chez des patients ayant développé une GVHD aiguë de grade II-IV suite à une greffe allogénique de cellules souches hématopoïétiques.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cytotect®CP, treatment as CMV prophylaxis in patients developing acute grade II-IV GVHD
    Cytotect®CP, traitement comme prophylaxie contre le CMV chez des patients ayant développé une GVHD aiguë de grade II-IV
    A.3.2Name or abbreviated title of the trial where available
    CMV-GVHD
    CMV-GVHD
    A.4.1Sponsor's protocol code number2020-42
    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 Sponsor CHU de Lille
    B.1.3.4CountryFrance
    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 supportCHU de Lille
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation clinical research direction
    B.5.2Functional name of contact pointKarim DAHACHE (CRA)
    B.5.3 Address:
    B.5.3.1Street Address6 rue du Professeur Laguesse
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number+33320444145
    B.5.5Fax number+33320445711
    B.5.6E-mailDRS.PROMOTION@CHRU-LILLE.FR
    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 No
    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 nameCytotect®CP Biotest 100 U/ml (vial50 ml et 10 ml)
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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
    Post-transplant human cytomegalovirus (CMV) infection is a challenge in patients receiving allogeneic hematopoietic cell transplants (allo-HCT) due to severe immunosuppression.
    In the absence of treatment, CMV infection can progress to CMV end-organ disease, CMV infection also has potential consequences on the immune system such as graft-versus-host disease (GvHD) and bacterial, viral or fungal infections. And remains an important cause of morbidity and mortality in allo-HCT patients
    L'infection à cytomégalovirus humain (CMV) post-transplantation(allo-HCT) constitue un défi en raison d'une immunosuppression sévère. En l'absence de traitement, l'infection à CMV peut évoluer vers une maladie des organes terminaux à CMV, L'infection à CMV a également des conséquences potentielles sur le système immunitaire telles que la maladie du greffon contre l'hôte (GvHD) et les infections bactériennes, virales ou fongiques. Et reste une cause importante de morbidité et de mortalité.
    E.1.1.1Medical condition in easily understood language
    Human cytomegalovirus (CMV) infection in patients who have developed acute grade II-IV GVHD after allogeneic hematopoietic cell transplantation
    CMV chez des patients ayant développé une GVHD aiguë de grade II-IV suite à une greffe allogénique de cellules souches hématopoïétiques
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To investigate Cytotect®CP efficacy in decreasing the rate of CMV infection within 16 weeks in patients developing acute grade II-IV GVHD after allo-HCT.
    Étudier l'efficacité de Cytotect®CP dans la réduction du taux d'infection CMV à 16 semaines de traitement chez des patients ayant développés une GVHD aiguë de grade II-IV après allo-HCT.
    E.2.2Secondary objectives of the trial
    - Evaluation of OS and NRM at 6 months
    - 16-week CI of EBV, adenovirus and BK virus co-infections
    - 16-week CI of CMV disease
    - 16-week CI of CMV infection
    - Evaluation of adverse events
    - Improvement of immune reconstitution after Cytotect®CP
    - Évaluation de la survie globale et de la mortalité sans rechute à 6 mois après un traitement par Cytotect®CP,
    - Evaluation, à 16 semaines du taux d’incidence cumulée des co-infections EBV, adénovirus et virus BK
    - Evaluation, à 16 semaines du taux d’incidence cumulée de la maladie par le CMV
    - Evaluation, à 16 semaines du taux d’incidence cumulée de l'infection par le CMV
    - Évaluation des événements indésirables
    - Evaluation de l’amélioration la reconstitution immunitaire après le traitement Cytotect®CP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients aged ≥ 18 years and able to provide informed consent
    - Patients before day +100 of first allo-HCT
    - Any indication, any stem cell source, any conditioning, any donor type or HLA-matching
    - Patients with positive CMV-serostatus before transplant
    - Patients with first episode of grade II-IV acute GVHD requiring systemic corticosteroids  1 mg/kg/day
    - Absence of CMV infection at the time of inclusion
    - Absence of other viral infections (EBV, adenovirus, BK virus) at the time of inclusion
    - Absence of dialysis
    - Absence of thrombotic microangiopathy
    - Absence of macrophage activation syndrome
    - Patients de sexe masculin ou féminin adultes (âge ≥ 18 ans) en capacité de signer un consentement éclairé,
    - Patients avant à J+100 de la greffe allo-HCT,
    - Toute indication, toute source de cellules souches, tout conditionnement, tout type de donneur ou appariement HLA,
    - Patients avec un statut sérologique CMV positif avant la transplantation,
    - Patients présentant un premier épisode de GVHD aiguë de grade II-IV nécessitant un traitement systémique par corticostéroïdes ≥ 1 mg / kg / jour,
    - Absence d'infection à CMV à l'inclusion,
    - Absence d'autres infections virales (EBV, adénovirus, virus BK) à l'inclusion,
    - Absence de dialyse,
    - Absence de micro angiopathie thrombotique,
    - Absence de syndrome d'activation des macrophages.
    E.4Principal exclusion criteria
    - Patients receiving corticosteroids > 0.5 mg/kg/day for more than 5 days before inclusion
    - Uncontrolled CMV infection within 30 days before inclusion
    - Inability to understand the investigational nature of the study or to give informed consent
    - ECOG Performance Status ≥ 3
    - Evidence of relapse of underlying disease
    - Patients receiving or having received anti-CMV treatment within 30 days before inclusion (acyclovir and valacyclovir are not considered as CMV prophylaxis)
    - Hypersensitivity to Cytotect®CP or to any of the excipients
    - Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA
    - Patients with any contra-indication to Cytotect®CP
    - Females either pregnant/breast-feeding or planning to become pregnant
    - Patients developing post-DLI grade II-IV acute GVHD
    - Freedom privacy
    - Absence of medical insurance cover
    - Patients ayant reçu un traitement par corticostéroïdes> 0,5 mg / kg / jour pendant au moins 5 jours avant l'inclusion,
    - Infection à CMV non contrôlée dans les 30 jours précédant l'inclusion,
    - Incapacité à comprendre la nature expérimentale de l'étude ou à donner son consentement éclairé,
    - Score de performance ECOG ≥ 3,
    - Rechute de la maladie initiale,
    - Patients recevant ou ayant reçu un traitement anti-CMV dans les 30 jours précédant l'inclusion (l'acyclovir et le valacyclovir ne sont pas considérés comme une prophylaxie CMV),
    - Hypersensibilité aux immunoglobulines humaines, en particulier chez les patients porteurs d'anticorps anti-IgA,
    - Hypersensibilité au Cytotect®CP ou à l'un de ces excipients,
    - Patients présentant une contre-indication au traitement par Cytotect®CP,
    - Femmes enceintes / allaitantes ou ayants un projet de grossesse, Patients développant une GVHD aiguë post-DLI de grade II-IV,
    - Personnes privées de liberté,
    - Absence de couverture d'assurance médicale.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of CMV infection within 16 weeks of Cytotect®CP therapy
    Taux d'infection à CMV pendant les 16 semaines de traitement par Cytotect®CP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As specified in the primary end point: Rate of CMV infection within 16 weeks of Cytotect®CP therapy
    Comme spécifié dans le critère principal:Taux d'infection à CMV pendant les 16 semaines de traitement par Cytotect®CP.
    E.5.2Secondary end point(s)
    - Time from inclusion to death from any cause or death without relapse of the underlying disease within 6 months
    - Time from inclusion to EBV, adenovirus or BK virus co-infection ≤ 16 weeks.
    - Time from inclusion to CMV infection ≤ 16 weeks.
    - Time from inclusion to CMV disease ≤ 16 weeks
    - Frequency of adverse events (grades 3 and 4) to be collected from 1st administration of Cytotect®CP to 1 month after the last administration of Cytotect®CP
    - Analysis of immune reconstitution under Cytotect®CP.
    - Délai entre l'inclusion et le décès quelle qu'en soit la cause ou le décès sans rechute de la maladie initiale à 6 mois de traitement par Cytotect®CP,
    - Délai entre l'inclusion et la survenue d’une co-infection à EBV, adénovirus ou virus BK pendant les 16 semaines de traitement par Cytotect®CP,
    - Délai entre l'inclusion et l'infection à CMV pendant les 16 semaines de traitement par Cytotect®CP,
    - Délai entre l'inclusion et la maladie à CMV pendant les 16 semaines de traitement par Cytotect®CP,
    - Fréquence des événements indésirables (grades 3 et 4) à collecter de la 1ère administration de Cytotect®CP à 1 mois après la dernière administration de Cytotect®CP,
    - Analyse de la reconstitution immunitaire sous Cytotect®CP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As spicified for each end point.
    Comme spécifié pour chaque critère d'évaluation secondaire.
    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 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 concerned5
    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 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
    Saudi Arabia
    Switzerland
    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 visit of the last patient included in the study
    Dernière visite du dernier patient inclus dans l'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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 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.1.3Elderly (>=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 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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 35
    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)
    None
    aucun
    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 Decision2021-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
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