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Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2014-002146-44
    Sponsor's Protocol Code Number:P120139
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-26
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-002146-44
    A.3Full title of the trial
    Multicenter trial for the treatment of Acute Lymphoblastic Leukemia (ALL) in younger adults (18-59 years) PROTOCOLE GRAALL-2014
    Protocole multicentrique de traitement des Leucémies Aiguës Lymphoblastiques (LAL) de l'adulte jeune (18-59 ans) PROTOCOLE GRAALL-2014

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Blood cancer in younger adults (18-59 years)
    Cancer du sang de l'adulte jeune (18-59 ans)
    A.3.2Name or abbreviated title of the trial where available
    GRAALL-2014
    A.4.1Sponsor's protocol code numberP120139
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02619630
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailcoralie.villeret@aphp.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 Yes
    D.2.1.1.1Trade name Atriance
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS Europharm Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtriance
    D.3.2Product code Nélarabine
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNélarabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mg/ml
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.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 Tasigna
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTasigna
    D.3.2Product code Nilotinib
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNilotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200 mg
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.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 cyclophosphamide
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter SAS
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecyclophosphamide
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcyclophosphamide
    D.3.10 Strength
    D.3.10.3Concentration number1g/50ml
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 4
    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 méthotrexate
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratiore BIODIM
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameméthotrexate
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNméthotrexate
    D.3.10 Strength
    D.3.10.3Concentration number25mg/mL
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 5
    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 vincristine
    D.2.1.1.2Name of the Marketing Authorisation holderEG LABO-LABORATOIRES EUROGENERICS
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namevincristine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvincristine
    D.3.10 Strength
    D.3.10.3Concentration number1mg/mL
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 6
    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 cytarabine
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer holding france
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecytarabine
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcytarabine
    D.3.10 Strength
    D.3.10.3Concentration number2g
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 7
    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 Etoposide
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA SANTE
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEtoposide
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtoposide
    D.3.10 Strength
    D.3.10.3Concentration number20mg/ml
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 8
    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 dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire CTRS
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedexamethasone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdexaméthasone
    D.3.10 Strength
    D.3.10.3Concentration number40mg
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 9
    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 prednisone
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameprednisone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNprednisone
    D.3.10 Strength
    D.3.10.3Concentration number20 mg
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 10
    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 6-mercaptopurine
    D.2.1.1.2Name of the Marketing Authorisation holderAspen pharma trading limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name6-mercaptopurine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmercaptopurine
    D.3.10 Strength
    D.3.10.3Concentration number50mg
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 11
    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 daunorubicine
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS FRANCE
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedaunorubicine
    D.3.4Pharmaceutical form Powder for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdaunorubicine
    D.3.10 Strength
    D.3.10.3Concentration number20 mg
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 12
    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 idarubicine
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameidarubicine
    D.3.4Pharmaceutical form Powder for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNidarubicine
    D.3.10 Strength
    D.3.10.3Concentration number10 mg
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 13
    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 L-Asparaginase
    D.2.1.1.2Name of the Marketing Authorisation holderEUSAPHARMA
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameL-Asparaginase
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNL-Apsaraginase
    D.3.10 Strength
    D.3.10.3Concentration number10000 UI
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 14
    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 G-CSF
    D.2.1.1.2Name of the Marketing Authorisation holderCHUGAI PHARMA FRANCE
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameG-CSF
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlénograstim
    D.3.10 Strength
    D.3.10.3Concentration number34 MUI/mL
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 15
    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 imatinib
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LIMITED
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameimatinib
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNimatinib
    D.3.10 Strength
    D.3.10.3Concentration number100 mg
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 16
    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 Blincyto
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBLINATUMOMAB
    D.3.4Pharmaceutical form Powder for concentrate and solution 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 INNBLINCYTO
    D.3.9.3Other descriptive nameBLINATUMOMAB
    D.3.9.4EV Substance CodeSUB35403
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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) 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.IMP: 17
    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 Oncaspar
    D.2.1.1.2Name of the Marketing Authorisation holderBaxalta Innovations GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameoncaspar
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGASPARGASE
    D.3.9.1CAS number 130167-69-0
    D.3.9.4EV Substance CodeSUB03666MIG
    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) 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.IMP: 18
    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.2.1.1.2Name of the Marketing Authorisation holdermedac GmbH
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameasparaginase
    D.3.4Pharmaceutical form Powder for 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.3.9.1CAS number 9015-68-3
    D.3.9.3Other descriptive nameASPARAGINASE
    D.3.9.4EV Substance CodeSUB12950MIG
    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) 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
    Patients with de novo acute lymphoblastic leukemia of young adults.
    -GRAALL-2014/B: Ph- B lineage ALL
    -GRAALL-2014/T et ATRIALL: T-ALL
    -GRAAPH-2014: ALL Ph+
    Patients présentant une Leucémie Aigue Lymphoblastique de l'adulte jeune de novo.
    -GRAALL-2014/B : LAL de la lignée B Ph-
    -GRAALL-2014/T et ATRIALL : LAL T
    -GRAAPH-2014 : LAL Ph+
    E.1.1.1Medical condition in easily understood language
    Acute Lymphoblastic Leukemia
    Leucémie Lymphoblastique Aigüe
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic 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 improve the results of our pediatric-inspired approach for patients
    with B-lineage Ph-negative ALL, T-lineage ALL or Ph+ ALL. For this
    purpose, we will consider the characteristics of ALL (using the new risk
    classification system) as well as age-related toxicities in order to
    improve tolerance.
    -GRAALL-2014/B: To prospectively validate the new risk model, based
    on MRD1 response level and KMT2A (=MLL) and IKZF1 gene status
    -GRAALL-2014/T: To prospectively validate the new risk factors based
    on MRD1 response level and NOTCH1/FBXW7/RAS/PTEN gene status.
    ATRIALL substudy : To evaluate the efficacy of nelarabine-based
    consolidation and maintenance therapy in term of RFS in HR patients
    -GRAAPH-2014: Non-inferiority of the experimental arm (arm B)
    compared to the control arm (arm A) in terms of Major Molecular
    Response (MMolR) after the 4th cycle (MRD4)
    Améliorer les résultats obtenus avec la stratégie d'inspiration
    pédiatrique pour les patients présentant une LAL de la lignée B Ph-, une
    LAL de la lignée T ou une LAL Ph+. En considérant à la fois les
    caractéristiques de la LAL (nouveau système de classification du risque)
    et les toxicités liées à l'âge afin d'améliorer la tolérance.
    -GRAALL-2014/B : valider de façon prospective le nouveau modèle de
    risque basé sur le niveau de réponse MRD1 et sur le statut du gène
    KMT2A (=MLL) et IKZF1.
    -GRAALL-2014/T : valider les nouveaux facteurs de risque basés sur la
    réponse à MRD1 et le statut des gènes NOTCH1/FBXW7/RAS/PTEN.
    Etude ATRIALL : évaluer l'efficacité de la nélarabine en consolidation et
    en entretien en termes de RFS chez des patients de HR.
    -GRAAPH-2014 : démontrer la non-infériorité du bras expérimental par
    rapport au bras contrôle en termes de réponse moléculaire majeure
    (MMolR), à l'issue du 4ème cycle (MRD4).
    E.2.2Secondary objectives of the trial
    -GRAALL-2014/B and QUEST: Evaluate the level of MRD by Ig-TCR (to
    demonstrate the non inferiority of DFS at 4 years by comparison to the
    historical group (<60%))
    -GRAALL-2014/Tet ATRIAL: Appreciate the toxicity of nelarabine-in
    consolidation, followed by allo-SCT or further consolidation and
    maintenance therapy; Evaluate MRD level, monitored by Ig-TCR;
    Cumulative incidence of relapse (CIR) and non-relapse mortality (NRM);
    Relapse-free survival (RFS) and overall survival (OS); RFS, CIR, NRM and
    OS after censoring at SCT in first CR
    -GRAAPH-2014: Comparison of the experimental arm and of the control
    arm in terms of tolerance, CIR, EFS and OS
    -GRAALL-2014/B et QUEST : évaluer le niveau de la MRD par Ig-TCR
    (montrer la non infériorité sur la DFS à 4 ans par rapport au groupe
    historique (<60%)).
    -GRAALL-2014/Tet ATRIALL : évaluer la toxicité des cycles de nélarabine
    en consolidation suivie d'une allogreffe de CSH ou consolidation et
    traitement d'entretien ; évaluer le niveau de la MRD par Ig-TCR ;
    incidence cumulée de rechute et mortalité non reliée à la rechute ; survie
    sans rechute, survie globale ; RFS, CIR, NRM et OS après censure à
    l'allogreffe en première RC.
    -GRAAPH-2014 : comparaison des 2 bras en termes de tolérance, d'ICR,
    de survie sans évènement et de survie globale.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    GRAALL-2014/T et Etude ATRIALL (LAL T)
    GRAALL-2014/T et Etude ATRIALL (LAL T)
    E.3Principal inclusion criteria
    General criteria :
    1. Whose blood and bone marrow explorations have been completed
    before the steroids prephase
    2. Aged 18 to 59 years old with not previously treated ALL (including
    intrathecal injections) newly diagnosed according to the WHO 2008
    definition with > or = 20% bone marrow blasts
    3. Without other evolving cancer (except basal cell carcinoma of the skin
    or "in situ" carcinoma of the cervix) or its treatment should be finished
    at least since 6 months
    4. With ECOG < or = 3
    5. With or without central nervous system (CNS) or testis involvement
    6. Who have received or being receiving the steroid prephase
    7. With efficient contraception for women of childbearing age (excluding
    estrogens and IUS)
    8. Having signed a written informed consent
    9. With health insurance coverage
    GRAALL-2014/B specific:
    1. With B-ALL
    2. Whose karyotype shows no t(9;22) and/or the absence in molecular
    biology of BCR-ABL marker
    GRAALL-2014/T specific:
    1. With T-ALL
    ATRIALL specific:
    1. Included in GRAALL-2014/T
    2. With HR T-ALL
    3. ECOG < or = 2
    4. In CR after one or two induction cures and having received the three
    blocks of consolidation 1
    5. Without documented CNS involvement at diagnosis
    6. With or without allogeneic donor
    GRAAPH-2014 specific:
    1. With Ph+ ALL (confirmed diagnosis of the Philadelphia chromosome
    defined by the reciprocal translocation of chromosomes 9 and 22,
    t(9;22) and/or presence of the BCR-ABL molecular maker)
    2. Having received no previous treatment for this hemopathy (including
    IT injection)
    Critères généraux :
    1.Patient(e) dont les bilans médullaire et sanguin ont pu être réalisés
    avant le début de la préphase par stéroïdes.
    2.Agé(e)s de 18 à 59 ans inclus présentant une LAL non préalablement
    traitée (y compris injection intrathécale) et nouvellement diagnostiquée
    selon les critères de l'OMS 2008, avec un pourcentage de blastes
    médullaires > ou = 20%.
    3.Indemne de tout cancer en évolution (sauf épithélioma basocellulaire
    ou carcinome in situ du col utérin), ou dont le traitement chimio ou
    radiothérapique est terminé depuis au moins 6 mois.
    4.Dont l'ECOG < ou = 3.
    5.Avec ou sans localisation neuroméningée ou atteinte testiculaire.
    6.Ayant reçu (ou recevant) la pré-phase par stéroïdes.
    7.Bénéficiant d'une contraception efficace pour les femmes en âge de
    procréer (en excluant les oestrogènes et le stérilet).
    8. Ayant signé le formulaire de consentement éclairé.
    9.Affilié(e) à un régime de sécurité sociale.
    Spécifiques GRAALL-2014/B :
    1. Présentant une LAL B.
    2.Dont le caryotype ne présente pas de t(9;22) et/ou absence en
    biologie moléculaire d'un marqueur BCR-ABL.
    Spécifique GRAALL-2014/T :
    1.Présentant une LAL T.
    Spécifiques ATRIALL :
    1.Inclus(e) dans le GRAALL-2014/T.
    2.Présentant une LAL-T de haut risque.
    3.ECOG < ou = 2.
    4.En rémission complète après 1 ou 2 cures d'induction et ayant reçu les
    3 blocs de la consolidation n°1.
    5.Ne présentant pas d'atteinte du SNC au diagnostic.
    6.Avec ou sans projet d'allogreffe.
    Spécifiques GRAAPH-2014 :
    1. présentant une LAL à chromosome Philadelphie (diagnostic confirmé
    de chromosome Philadelphie défini par la présence d'une translocation
    réciproque entre les chromosomes 9 et 22 ; t(9 ;22) et/ou la présence
    d'un marqueur moléculaire BCR-ABL).
    2.N'ayant reçu aucun traitement préalable pour cette hémopathie (y compris injection intrathécale).
    E.4Principal exclusion criteria
    Principal criteria:
    1. Myocardial infarction within 6 months prior to inclusion in the trial,
    cardiomyopathy, LEVF <50% and or RF <30%
    2. Women of childbearing potential not willing to use an effective form of
    contraception during participation in the study and at least three months
    thereafter. Patients not willing to ensure not to beget a child during
    participation in the study and at least three months thereafter
    3. Not able to bear with the procedures or the frequency of visits
    planned in the trial
    4. Unable to consent, under tutelage or curatorship, or judiciary
    safeguard
    5. Treated with any other investigational agent or participation in
    another trial within 30 days prior to entering this study
    GRAALL-2014/B:
    1. With lymphoblastic lymphoma and bone marrow blasts <20%,
    Burkitt-type ALL or with antecedents of CML or other myeloproliferative
    neoplasm
    2. HIV, HTLV-I or HCV seropositivity or chronic HBV hepatitis (HbsAgpositive)
    3. With contra-indication of anthracyclines or any other general or
    visceral contra-indication to intensive therapy except if considered
    related to the ALL:
    a.AST or ALT >5 x ULN
    b.Total bilirubin >or= 2.5 x ULN
    c.Creatinine >1.5 x ULN or creatinine clearance <50 mL/mn
    GRAAL-2014/T:
    1. With lymphoblastic lymphoma and bone marrow blasts <20%,
    Burkitt-type ALL or with antecedents of CML or other myeloproliferative
    neoplasm
    2. Other active malignancy
    3. Women of childbearing potential not willing to use an effective form of
    contraception during participation in the study and at least three months
    thereafter. Patients not willing to ensure not to beget a child during
    participation in the study and at least three months thereafter
    4. Treated with any other investigational agent or participation in
    another trial within 30 days prior to entering this study
    5. with severe evolving infection, or known HIV or HTLV1 seropositivity,
    or chronic hepatitis B (HbsAg-positive) or C
    6. With contra-indication of anthracyclines or any other general or
    visceral contra-indication to intensive therapy except if considered
    related to the ALL:
    a.AST or ALT >5 x ULN
    b.Total bilirubin >or= 2.5 x ULN
    c.Creatinine >1.5 x ULN or creatinine clearance <50 mL/mn
    ATRIALL specific:
    1. With ECOG status > or = 3 after consolidation 1
    2. With CNS disease at diagnosis, or symptomatic CNS disease, or
    uncontrolled epilepsy
    3. With peripheral neuropathy grade >or= 2 after consolidation 1
    4. With abnormal laboratory values as defined below after consolidation
    1
    a. AST and/or ALT >or= 5 x ULN
    b. Total bilirubin >or= 1.5 x ULN
    c. Creatinine >or= 1.5 x ULN or creatinine clearance <50 ml/min
    d. Serum amylase and lipase >or= 1.5 x ULN
    5. With active uncontrolled infection, any other concurrent disease or
    medical conditionthat is deemed to interfere with the conduct of the
    study as judged by the investigator
    6. With childbearing potential not willing to use an effective form of
    contraception during participation in the study and at least three months
    thereafter. Patients not willing to ensure not to beget a child during
    participation in the study and at least three months thereafter
    7. With known hypersensitivity to nelarabine
    GRAAPH-2014:
    1. Previously treated with Tyrosine Kinase Inhibitor
    2. With another active malignancy
    3. With general or visceral contra-indication to intensive therapy (except
    if considered related to the ALL):
    a. ASAT and/or ALAT>or= 2.5 x ULN
    b. Total bilirubin >1.5 x ULN
    c. Creatinine >1.5 x ULN or creatinine clearance <50 mL/mn
    d. Serum amylase or lipase >1.5 x ULN or antecedents of acute
    pancreatitis
    4. With heart failure, including at least one of the following criteria:
    a. left ventricular ejection fraction <50% or below the lowest normal
    threshold, as determined by ECG or heart failure
    b. impossibility to measure the QT interval on ECG
    c. complete left bundle branch block
    d. pacemaker
    e. congenital long QT syndrome of known familial antecedents of long QT
    syndrome
    f. antecedents or current ventricular or atrial tachyarrhythmia, clinically
    significant
    g. baseline bradycardia (<50 bpm) clinically significant
    h. QTc>450 msec established on the mean of 3 baseline ECG
    i. Antecedents of myocardial infarct in the past 6 months
    j. Instable angor within the past 12 months
    k. Any heart condition clinically significant
    5. active uncontrolled infection, any other concurrent disease deemed to
    interfere with the conduct of the study as judged by the investigator
    6. Women of childbearing potential not willing to use an effective form of
    contraception during participation in the study and at least three months
    thereafter. Patient not willing to ensure not to beget a child during
    participation in the study and at least three months thereafter
    7. Having received an investigational treatment or participation in
    another trial within 30 days prior to entering this study
    Critères principaux:
    1.Infarctus du myocarde dans les 6 mois précédent l'inclusion dans
    l'essai, cardiomyopathie, FEV <50% ou FR <30%
    2.Test de grossesse positif ou allaitante
    3.Ne pouvant se soumettre aux procédures ou à la fréquence des visites
    telles que prévues par le protocole
    4.Hors d'état de consentir, sous tutelle, sous curatelle, sous sauvegarde
    de justice
    Spécifiques GRAALL-2014/B:
    1.Atteint(e) de LAL de type Burkitt, ou ayant des antécédents de LMC ou
    d'autre syndrome myéloprolifératif
    2.Présentant une infection sévère évolutive, ou une séropositivité
    connue pour le virus HIV ou HTLV-1, ou présentant une hépatite active
    liée au virus B ou C
    3.Présentant une contre-indication aux anthracyclines ou toute autre contre-indication générale ou viscérale aux traitements intensifs sauf si
    elle est considérée comme reliée à la LAL:
    a.ASAT ou d'ALAT >5 N
    b.Bilirubine totale >ou= 2,5 N
    c.Créatinine sérique > 1,5 N ou clairance à la créatinine <50 ml/min
    Spécifiques GRAALL-2014/T:
    1.Atteint(e) de LAL de type Burkitt, ou ayant des antécédents de LMC ou
    d'autre syndrome myéloprolifératif
    2.Autre maladie maligne active
    3.Susceptible de procréer et ne désirant pas utiliser de contraception
    efficace pendant la durée de l'étude et jusqu'à trois mois après la fin de
    celle-ci. Patient(e) ne désirant pas s'engager à ne pas concevoir d'enfant
    pendant la durée de l'étude et jusqu'à trois mois après la fin de celle-ci
    4.Ayant reçu un produit en cours d'expérimentation ou participant à un
    autre essai thérapeutique dans les 30 jours précédents
    5.Présentant une infection sévère évolutive, ou une séropositivité
    connue pour le virus HIV ou HTLV-1, ou présentant une hépatite active
    liée au virus B ou C
    6.Présentant une contre-indication aux anthracyclines ou toute autre
    contre-indication générale ou viscérale aux traitements intensifs sauf si
    elle est considérée comme reliée à la LAL:
    a.ASAT ou d'ALAT >5 N
    b.Bilirubine totale >ou= 2,5 N
    c.Créatinine sérique >1,5 N ou clairance à la créatinine <50 ml/min
    Spécifiques ATRIALL:
    1.Avec un ECOG >ou= 3 après la consolidation n°1
    2.Présentant une atteinte du SNC au diagnostic, ou présentant une
    pathologie symptomatique du SNC, ou une épilepsie non contrôlée
    3.Atteint(e) d'une neuropathie périphérique de grade >ou= 2 après la
    consolidation n°1
    4.Présentant des anomalies biologiques définies comme suit après la
    consolidation n°1:
    a.ASAT et/ou ALAT >ou= 5 N
    b.bilirubine totale >ou= 1,5 N
    c.créatinine > ou = 1,5 N ou clairance de la créatinine <50 mL/min
    d.lipase ou amylase sériques >ou= 1,5 N
    5.Atteint(e) d'une infection active non contrôlée ou de toute autre
    pathologie concomitante ou condition médicale considérée par
    l'investigateur comme à risque d'interférer avec la conduite de l'étude
    6.Susceptible de procréer ne désirant pas utiliser de contraception
    efficace pendant la durée de l'étude et jusqu'à trois mois après la fin de
    celle-ci. Patient(e) ne désirant pas s'engager à ne pas concevoir d'enfant
    pendant la durée de l'étude et jusqu'à trois mois après la fin de celle-ci
    7.Présentant une hypersensibilité connue à la nélarabine
    Spécifiques à GRAAPH-2014:
    1.Préalablement traité(e) par Inhibiteur de Tyrosine Kinase
    2.Atteint(e) d'une autre affection maligne évolutive
    3.Présentant une contre-indication générale ou viscérale aux traitements
    intensifs:
    a.ASAT et/ou ALAT >2,5 N
    b.Bilirubine totale >1,5N
    c.Taux d'amylase ou de lipase sériques >ou= 1,5 N ou antécédents de
    pancréatite aigüe ou chronique,
    4.Présentant une insuffisance cardiaque, incluant au moins l'un des
    critères suivants:
    a.une fraction d'éjection ventriculaire gauche <50% ou au-dessous de la
    limite inférieure de la normale, telle que déterminée par l'ECG ou
    insuffisance cardiaque
    b.une incapacité à déterminer l'intervalle QT sur l'ECG,
    c.un bloc de branche gauche complet,
    d.la présence d'un pacemaker,
    e.un syndrome du QT long congénital ou des antécédents familiaux
    connus de syndrome du QT long,
    f.des antécédents ou présence de tachyarythmies ventriculaires ou
    atriales, cliniquement significatifs,
    g.une bradycardie de repos cliniquement significative,
    h.QTc >450 msec déterminé sur la moyenne de 3 d'ECG de base,
    i.des antécédents d'infarctus du myocarde dans les 6 derniers mois,
    j.un angor instable au cours des 12 derniers mois,
    k.toute autre maladie cardiaque cliniquement significative
    5.Présentant une infection active non contrôlée ou toute autre maladie
    concomitante pouvant interférer avec le bon déroulement de l'étude
    selon l'investigateur
    6.Susceptible de procréer ne désirant pas utiliser de contraception
    efficace pendant la durée de l'étude et jusqu'à trois mois après la fin de
    celle-ci. Patient ne désirant pas s'engager à ne pas concevoir d'enfant
    pendant la durée de l'étude et jusqu'à trois mois après la fin de celle-ci.
    7.Ayant reçu un produit en cours d'expérimentation ou participant à un
    autre essai thérapeutique dans les 30 jours précédents
    E.5 End points
    E.5.1Primary end point(s)
    -GRAALL-2014/B :
    Disease free survival (DFS) at 4 years, depending on the status of KMT2A
    (=MLL) and IKZF1 genes and on MRD1 assessed after the induction cure
    or on D1 of consolidation 1
    -GRAALL-2014/T et ATRIALL :
    Analysis of the new risk factors based on MRD1 response level and
    NOTCH1/FBXW7/RAS/PTEN gene status by comparing the historical
    results of GRAALL-2005 with those of GRAALL-2014 in an identical
    population ( T-lineage ALL aged 18 to 59 years old),
    DFS at 4 years in SR patients, according to the status of
    NOTCH1/FBXW7/RAS/PTEN and of MRD1 evaluated at the end of the
    induction cure or on D1 or consolidation cure 1
    RFS at 4 years, in the ATRIALL substudy
    -GRAAPH-2014 :
    Major Molecular Response (MMolR) defined as a BCR-ABL/ABL ratio <
    0.1% in the bone marrow sample of MRD4
    -GRAALL-2014/B :
    Survie sans maladie (DFS) à 4 ans, en fonction du statut du gène KMT2A
    (MLL) et IKZF1 et de la MRD1 évaluée à l'issue de la cure d'induction ou
    au J1 de la cure de consolidation 1.
    -GRAALL-2014/T et ATRIALL :
    Analyse des nouveaux facteurs de risque basés sur la réponse à MRD1 et
    le statut des gènes NOTCH1/FBXW7/RAS/PTEN en comparant les
    résultats historiques du GRAALL-2005 avec ceux du GRAALL-2014 chez
    une population identique de patients (LAL de la lignée T Ph-, âgés de 18
    à 59 ans),
    Survie sans maladie à 4 ans chez les patients RS, en fonction du statut
    des gènes NOTCH1/FBXW7/RAS/PTEN et de la MRD1 évaluée à l'issue
    de la cure d'induction ou au J1 de la cure de consolidation 1,
    Survie sans rechute à 4 ans dans l'étude ATRIALL.
    -GRAAPH-2014 :
    Réponse moléculaire majeure (MMolR), définie par un ratio BCRABL/
    ABL < 0.1% sur le prélèvement médullaire de MRD4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    .
    .
    E.5.2Secondary end point(s)
    GRAALL-2014/B:
    Cumulative incidence of relapse (CIR) at 4 years and non-relapse related
    mortality (NRM),
    DFS, CIR, NRM and OS after censoring at allo-SCT in first CR,
    MRD follow-up at different treatment times (cf infra § MRD monitoring).
    GRAALL-2014/T:
    Overall survival,
    Cumulative incidence of relapse (CIR) and non-relapse mortality (NRM),
    DFS, CIR, NRM and OS after censoring at SCT in first CR,
    Evaluation of nelarabine toxicity,
    Proportion of patients having received the 5 cycles of nelarabine.
    MRD follow-up at various times of treatment (cf infra § MRD
    monitoring).
    GRAAPH-2014:
    Tolerance
    Complete remission after cycle 1,
    Cumulative incidence of treatment- and transplantation-related
    mortality,
    Cumulative incidence of relapse,
    Relapse free survival,
    Event free survival,
    Overall survival,
    Investigation of T315I mutation and of resistance (mutations will be
    assessed by RQ-PCR sequencing in case of progression or relapse).
    GRAALL-2014/B:
    Incidence cumulée de rechute (CIR) à 4 ans et mortalité non reliée à la
    rechute (NRM),
    DFS, CIR, NRM et OS après censure à l'allogreffe en première RC,
    Suivi de la MRD à différents temps du traitement (cf infra § monitoring
    MRD).
    GRAALL-2014/T:
    Survie globale,
    Incidence cumulée de rechute (CIR) et mortalité non relié à la rechute
    (NRM),
    DFS, CIR, NRM et OS après censure à l'allogreffe en première RC,
    Evaluation de la toxicité de la nélarabine,
    Taux de patients ayant reçu les 5 cycles de nélarabine,
    Suivi de la MRD à différents temps du traitement (cf infra § monitoring
    MRD).
    GRAAPH-2014:
    Tolérance,
    Réponse complète après le cycle 1,
    Incidence cumulée du taux de mortalité lié au traitement et à la greffe,
    Incidence cumulée du taux de rechute,
    Survie sans rechute,
    Survie sans événement,
    Survie globale,
    Recherche de mutation T315I et de résistance (les mutations seront
    évaluées par séquençage de RQ-PCR en cas de progression ou de
    récidive).
    E.5.2.1Timepoint(s) of evaluation of this end point
    .
    .
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    France
    Switzerland
    Belgium
    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 last subject
    Dernier suivi du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months0
    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.1.2.1Number of subjects for this age range: 1040
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-06-26. Yes
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 936
    F.4.2.2In the whole clinical trial 1040
    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)
    If the patient wish to stop prematurely his/her participation to the
    trial, he/she will be asked to have a final clinical examination. The
    medical team will then adapt his/her care according to the
    characteristics of his/her disease.
    If the disease is worsening or if new therapies are developed,
    indicating that the current therapy proposed does not or any longer
    correspond to his/her best interest, it will be halted.
    Si l'étude est arrêtée prématurément, un dernier examen clinique sera
    fait. L'équipe médicale adaptera la suite de la prise en charge en
    fonction des caractéristiques de la maladie.
    Si la maladie s'aggrave ou si de nouveaux traitements sont mis au
    point, indiquant ainsi que le traitement proposé ne correspond plus au
    mieux des intérêts du patient, celui-ci sera interrompu.
    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 Decision2015-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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