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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2008-004884-20
    Sponsor's Protocol Code Number:BRD 08/7-J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-10-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-004884-20
    A.3Full title of the trial
    Protocole Clinique de Phase II multicentrique non randomisé évaluant l’efficacité, la tolérance et la toxicité d’un conditionnement à intensité réduite combinant Clofarabine (Evoltra) + Busulfan IV (Busilvex) + ATG (Thymoglobuline) (CBT) chez des patients nécessitant une allogreffe pour une MDS, LAM ou une LAL à haut risque
    A.3.2Name or abbreviated title of the trial where available
    CLORIC
    A.4.1Sponsor's protocol code numberBRD 08/7-J
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de Nantes
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Evoltra
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Genzyme BV
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/082
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 BUSILVEX
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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/3/00/011
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 3
    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 Thymoglobuline
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe BV
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    LAL Leucémie Aiguë lymphoblastique
    LAM Leucémie Aiguë Myéloblastique
    MDS Syndrome MyéloDysplasique
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000878
    E.1.2Term Acute myeloblastic leukemia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000846
    E.1.2Term Acute lymphocytic leukaemia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’activité anti-leucémique et immunosuppressive de la clofarabine dans le contexte des greffes allogéniques à conditionnement atténué chez des patients porteurs de MDS/LAM et LAL à haut risque.
    En renforçant le conditionnement classique Flu-Bu-ATG avec un médicament à activité antitumorale démontrée dans les MDS/LAM et LAL de haut risque (la Clofarabine remplace la Fludarabine), nous souhaitons démontrer une diminution de l’incidence du taux de rechute à 1 an de 30% chez ces patients pour obtenir 25% de rechutes seulement à 1 an post-allogreffe (55% de rechute estimée à 1 an).
    E.2.2Secondary objectives of the trial
    · Etude de la Prise de Greffe
    · Etude de l’incidence et de la sévérité de la GVHD aiguë et chronique
    · Evaluation de la survie sans progression et de la survie globale
    · Evaluation de la toxicité de la procédure (conditionnement et allogreffe)
    · Etude du chimérisme
    · Etude de la reconstitution immunitaire post-greffe
    . taux de rejet de greffe ou de non prise de greffe
    . complications de grade 3/4
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    LA RECONSTITUTION IMMUNITAIRE

    On étudiera à 3, 6, 9 et 12 mois la proportion plus ou moins la fonctionnalité de cellules lymphocytaires T (avec sous-populations T4 et T8), cellules B , cellules NK, cellules Tregs et dendritiques, TRECS ( T-cell receptor excision circles, permettant d’apprécier la fonction thymique (Jimenez et al, 2007) à partir du sang périphérique des patients
    E.3Principal inclusion criteria
    1. •Age: supérieur à 50 ans et inférieur à 65 ans
    2. une des hémopathies suivantes
    MDS •Myelodysplasie: Score IPSS I-2 ou élevé au moment de la greffe (Greenberg, 1997), patients acutisés en LAM ayant obtenu une Rémission Complète (<5% de blastes dans la moelle) après chimiothérapie d’induction.
    LAL •LAL en RC1 de haut risque défini par au moins 1 des critères suivants (étude GRAALL 2003 & 2005): age >55 ans, t(9-22); t(4-11), t(1-19), hyperleucocytose >30 000 GB si LAL-B, near triploidie, haploidie, atteinte initiale du systeme nerveux central clinique ou biologique (LCR+), LAL B CD10- (pro-B ou pre-B CD10-), caryotype complexe (>=5 anomalies)
    •LAL en rémission au delà de la RC1
    LAM •a) LAM en RC1 de haut risque cytogenetique (Grimwade et al, 1998 ; Jourdan et al, 2005) : caryotype complexe (>3 anomalies), del 5q/-5, –7, rearrangement 3q, t(9-22), t(6-9) ou rearrangement 11q23 sauf la t(9-11)
    •b) LAM en RC1 de risque cytogenetique intermédiaire (Grimwade et al, 1998 ; Jourdan et al, 2005) avec au moins un des facteurs suivants: obtention de la RC1 en 2 cures, FAB MO, M6, M7, >30000GB au diagnostic
    c)LAM en rémission au delà de la RC1
    3. •Donneur vivant familial ou de fichier HLA 10/10 (HLA ABC, DRB1, DQB1)
    4. •Consentement informé signé
    5. •Score OMS <=2 (Annexe 5)
    6. •Absence d’infection systémique active
    7. •FEVG >40%
    8. •DLCO >50%
    9. •Hépatite B, C, VIH –
    10. •Absence de Grossesse (dosage ß HCG)
    11. •Absence d’insuffisance rénal ou hépatique sévère : créatinine sérique < 2 la limite supérieure de la normale (LSN) ou avec une bilirubine sérique <1.5 fois LSN ou des ASAT et ALAT < 5 fois la LSN.
    12. Score de Sorror <3 (voir Annexe 6)
    13 méthode contraceptive efficace chez les patients en age de procréer
    E.4Principal exclusion criteria
    1 Hypersensibilité connue à la clofarabine ou à l’un des excipients
    2 Insuffisance rénale sévère ou insuffisance hepatique sévère
    3 Un ATCD de traitement par clofarabine n’est pas un critère d’exclusion sauf pour les patients réfractaires après ce traitement.
    4 Autres hémopathies que la MDS, LAM ou LAL.
    5 Patients ayant des antécédents d’allogreffe et ayant fait une GVHD de grade > 2 après la première allogreffe.
    6 Antécédent de greffe et si le délai greffe-mini greffe est < 2 mois.
    7 Sérologie HIV positive.
    8 Grossesse.
    9 Antécédents ou maladies psychiatriques évolutives.
    10 Antécédents d’un autre cancer évolutif ou survenu dans les cinq années précédentes.
    11 Patient ayant une affection concomitante grave et non contrôlée.
    12 Contre indications à l’un des éléments du conditionnement envisagé.
    13 Patient ayant plus de 3 lignes de traitement à l’inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal est l'améioration du taux de survie sans rechute à un an .
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned6
    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 Information not present in EudraCT
    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
    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 months0
    E.8.9.1In the Member State concerned 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) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    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 state30
    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 Decision2008-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-08
    P. End of Trial
    P.End of Trial StatusOngoing
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