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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2014-004849-26
    Sponsor's Protocol Code Number:Parachute04
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004849-26
    A.3Full title of the trial

    Prospective Analysis of an individualized dosing Regimen of ATG (Thymoglobulin) in Children Undergoing HCT: redUcing Toxicity and improving Efficacy – a single arm phase II study
    Evaluatie van een geindividualiseerd doseerregime van ATG (Thymoglobuline) in kinderen die een hematopoietische cel transplantatie ondergaan: verminderen van toxiciteit en het verbeteren van effectiviteit (PARACHUTE-trial).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Parachute trial: research on individualized dosing regimen of Thymoglobuline
    Parachute onderzoek: wetenschappelijk onderzoek naar een geïndividualiseerde dosering van het medicijn Thymoglobuline
    A.3.2Name or abbreviated title of the trial where available
    Parachute trial
    Parachute onderzoek
    A.4.1Sponsor's protocol code numberParachute04
    A.5.4Other Identifiers
    Name:Dutch Competent AuthorityNumber:NL51460.041.14
    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 SponsorUMC Utrecht
    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 supportSanofi-Aventis
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointR.Admiraal, MD
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.4Telephone number00310611210706
    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. name Thymoglobuline
    D. of the Marketing Authorisation holderGenzyme Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameThymoglobuline
    D.3.4Pharmaceutical form Powder for 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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
    Leukemia and immunedeficiency syndromes
    Leukemie en immuundeficientie syndromen
    E.1.1.1Medical condition in easily understood language
    Leukemia and immune disorders
    Leukemie en immuunstoornissen
    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 SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10024329
    E.1.2Term Leukemia
    E.1.2System Organ Class 100000004864
    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 whether an individualized dosing regimen for Thymoglobulin leads to a better immune reconstitution after HCT (definition as in primary endpoint), as compared to historically non-individualized treated patients receiving Thymoglobulin as a fixed dose per kilogram body weight. The individualized dosing regimen is based on a previously treated pediatric cohort on which a population PK-PD analysis was performed. The dosing regimen was compiled using this cohort, taking into account the influence of body weight and pre-Thymoglobulin lymphocyte count and the observed variability.
    Het doel van dit onderzoek is het onderzoeken van de effecten van een geïndividualiseerd doseerregime voor Thymoglobuline op immuunherstel na HCT. Hierbij worden de uitkomsten vergeleken met historische niet-geindividualiseerd behandelde patiënten die Thymoglobuline kregen in een vaste dosis uitgedrukt in mg/kg.
    E.2.2Secondary objectives of the trial
    not applicable
    niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients eligible for a non-haplo-identical non-T-cell depleted HCT with Thymoglobulin as part of the conditioning regimen treated in the pediatric ward of the UMCU Utrecht or the LUMC Leiden
    • Any stem cell source
    • First transplantation
    • Age at time of transplantation < 18 years
    • Signed written informed consent according to local law and regulations
    • Lansky/Karnofsky ≥ 80%
    Patiënten geschikt voor een non-haplo-identical non-T-cell gedepleteerde HCT met Thymoglobulin als onderdeel van de standaardbehandeling behandeld op de kinderafdeling van het UMC Utrecht of het LUMC Leiden.
    • Elke bron van stamcellen
    • Eerste transplantatie
    • Leeftijd op het moment van transplantatie < 18 years
    • getekend informed consent volgens wettelijke voorschriften en regelingen
    • Lansky/Karnofsky schaal ≥ 80%
    E.4Principal exclusion criteria
    • Ex-vivo T-cell depleted grafts
    • Other serotherapy in conditioning (e.g. Campath, or Campath in the bag)
    • Received serotherapy within 3 months before this transplantation
    • Pregnancy or breast-feeding or unwilling to use adequate contraceptive methods
    • Sensibility to rabbit proteins or previous treatment with Thymoglobulin or other rabbit ATG
    • Acute or chronic infections, in which each form of immune suppression is contra-indicated
    • Patients not planned to receive or having received at least 90% or more than 110% of the intentioned dose of Thymoglobulin
    • Ejection fraction < 30% or shortening fraction < 15%
    • No complete morphological remission (CR-status) in bone marrow in case of malignancy
    • History of serious immune-mediated reactions or hypersensitivity to any biological product
    • Participation in other trial in which the dose of Thymoglobulin is fixed to amounts other than the individualized dose.

    E.5 End points
    E.5.1Primary end point(s)
    Incidence of CD4+ T-cell immune reconstitution, defined as a CD4+ T-cell count > 50 x 10e6/L in 2 consecutive measurements within 100 days.
    CD4+ T-cell immuunherstel, gedefinieerd als een CD4+ T-cell getal > 50 x 10^6/L in 2 opeenvolgende metingen binnen 100 dagen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    100 days
    100 dagen
    E.5.2Secondary end point(s)
    Survival (overall survival, event free survival, non-relapse mortality, relapse mortality)
    • Relapse incidence
    • Incidence of viral reactivations (CMV, Adenovirus, EBV, HHV6, BK-virus)
    • Acute graft versus host disease (according to Glucksberg criteria)
    • Chronic graft versus host disease (according to Shulman criteria)
    • Engraftment defined as a neutrophil count > 0.5 x 109/L with use of granulocyte-colony stimulating factor (G-CSF) within 40 days
    • Rejection defined as >95% recipient chimerism, or reinfusion of donor cells after successful engraftment
    • Prospective validation of the pharmacokinetic model
    • Lymphocyte subset reconstitution monitored throughout the treatment (including some rare populations) for future studies
    Survival (overall survival, event free survival, therapie-gerelateerde mortaliteit, recidief-gerelateerde mortaliteit)
    • Incidentie recidieven van maligniteiten
    • Incidentie van virale reactivaties (CMV, Adenovirus, EBV, HHV6, BK-virus)
    • Acute graft versus host disease (volgens Glucksberg criteria)
    • Chronische graft versus host disease (volgens Shulman criteria)
    • Engraftment gedefinieerd als een neutrofielengetal van > 0.5 x 10^9/L onder granulocyte-colony stimulating factor (G-CSF) binnen 40 days
    • Afstoting gedefinieerd als >95% patient chimerisme, of reinfusie van donorcellen na succesvolle engraftment
    • Prospectieve validatie van het PK-model
    • Reconstitutie van lymfocyten subsets gedurende de behandeling (inclusief zeldzame populaties) voor toekomstige studies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 6 months after last visit of last patient
    Binnen 6 maanden na laatste bezoek van laatste patient
    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 Yes
    E.6.7Pharmacodynamic Yes
    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. 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 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 Yes
    E. description
    Historische controles
    Historic controls
    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 concerned2
    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
    Laatste patient laatste visite
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 53
    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) Yes
    F. of subjects for this age range: 53
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    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)
    not applicable
    niet van toepassing
    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 Decision2015-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-01
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