{
  "FullStudy":{
    "Rank":217659,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518517",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GRASPALL2009-06"
          },
          "Organization":{
            "OrgFullName":"ERYtech Pharma",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia",
          "OfficialTitle":"Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia",
          "Acronym":"GRASPIVOTALL"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2009",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 6, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 7, 2017",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"ERYtech Pharma",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics, tolerability and maintain circulating asparaginase activity due to the protective barrier of the erythrocyte membrane.\n\nThis study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase.",
          "DetailedDescription":"This open, randomized international Phase 2/3 study will enrol patients with relapsed ALL. The co-primary endpoints were the duration of asparagine depletion < 2µmol/L and the incidence of asparaginase hypersensitivity during induction. Key secondary endpoints are complete remission (CR), minimal residual disease (MRD), event free survival (EFS) and overall survival (OS).The study was powered to detect 3-fold difference in the incidence of allergic reactions between treatments. patients will be randomized to GRASPA or to Reference L-asparaginase. Patients with history of hypersensitivity to previous L-asparaginase treatment will be treated with GRASPA (exploratory arm)"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Acute Lymphoblastic Leukemia, in Relapse"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "acute lymphoblastic leukemia",
              "relapse",
              "asparaginase"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2",
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"80",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"GRASPA",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).\n\nGRASPA® administration takes place as below:\n\nfor induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)\nfor consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: GRASPA"
                  ]
                }
              },{
                "ArmGroupLabel":"reference L-asparaginase",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"For patient randomized in control group, reference L-asparaginase 10,000 IU/m² will be administered every 3 days intravenously, in combination with standard chemotherapy (COOPRALL).\n\n•for induction phase:at Day 4 , D7, D10, D13 (F1 block ) then at Day 18, D21, D24, D27 (of F2 Blocks).\n\nNB: administrations take place at D6, D9, D12 and D15 in case of F1-F2 Induction is replaced by VANDA (according disease severity)\n\n•for consolidation phase: at D6, D9, D12 ofR2/R1 blocks, each time block of chemotherapy is given (up to 8 cycles).",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: L-asparaginase"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"GRASPA",
                "InterventionDescription":"one injection of GRASPA 150 IU/kg at each cycle of chemotherapy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "GRASPA"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "ERY001"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"L-asparaginase",
                "InterventionDescription":"3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "reference L-asparaginase"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "KIDROLASE"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"efficacy and toxicity combined",
                "PrimaryOutcomeDescription":"efficacy assessed according mean duration of asparaginase activity / toxicity assessed according incidence of allergic reaction whatever the grade",
                "PrimaryOutcomeTimeFrame":"1 month"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Molecular response rate",
                "SecondaryOutcomeTimeFrame":"1 month"
              },{
                "SecondaryOutcomeMeasure":"Plasma concentration of asparagine, aspartate, glutamine, glutamate and asparaginase",
                "SecondaryOutcomeTimeFrame":"0,1,3,6, 9 days post-dose"
              },{
                "SecondaryOutcomeMeasure":"Specific anti L-asparaginase antibodies",
                "SecondaryOutcomeTimeFrame":"0,10 days post-dose"
              },{
                "SecondaryOutcomeMeasure":"Event free survival",
                "SecondaryOutcomeTimeFrame":"6 and 12 month"
              },{
                "SecondaryOutcomeMeasure":"Relapse free survival",
                "SecondaryOutcomeTimeFrame":"6 and 12 month"
              },{
                "SecondaryOutcomeMeasure":"Overall survival",
                "SecondaryOutcomeTimeFrame":"6 and 12 month"
              },{
                "SecondaryOutcomeMeasure":"Percentage of patient with complete remission",
                "SecondaryOutcomeTimeFrame":"1 month"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatient from 1 to 55 years old (Children and adolescents from 1 to 17 years/ Adults from 18 to 55 years)\nPatients with 1st ALL relapse, which could be either isolated bone marrow relapse, or combined (medullary and extra-medullary) relapse, or extra-medullary isolated relapse; or lymphoblastic lymphoma (excepted Burkitt lymphoma) OR Failure to ALL first line treatment (no complete remission obtained)\nPatient previously treated with free E.Coli L-asparaginase form or pegylated one\nPerformance Status ≤ 2 (WHO score)\nPatient informed and consent provided (the 2 parents need to consent when children are below 18)\n\nExclusion Criteria:\n\nALL t(9;22) and/or BCR-ABL positive (Philadelphia chromosome positive)\nPatient with 2nd relapse and over\nWomen of childbearing potential without effective contraception as well as pregnant or breast feeding women\nPatient unable to receive treatments used in global chemotherapy protocols, due to general or visceral conditions such as:Severe cardiac impairment (NYHA grade 3 or 4 cardiomyopathy)/Serum creatinine 2 x ULN unless related to ALL /ALT or AST 5 x ULN unless related to ALL /Pancreatitis history /Other malignancy that ALL / Severe Infection, HIV positive, active hepatitis related to B or C virus infection / Trisomy 21 / Other serious conditions according to investigator's opinion\nKnown grade 4 allergic reaction to E.Coli L-asparaginase (according NCI-CTCAE, Version 3.0)\nHistory of grade 3 transfusional incident\nPresence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient\nPatient under concomitant treatment likely to cause hemolysis\nPatient undergoing yellow fever vaccination\nPatient under phenytoin treatment\nPatient included in previous clinical study less than 6 weeks ago",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"1 Year",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Yves Bertand, MD",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hopital Des Enfants Reine Fabiola",
                "LocationCity":"Bruxelles",
                "LocationCountry":"Belgium"
              },{
                "LocationFacility":"Chr de La Citadelle",
                "LocationCity":"Liege",
                "LocationCountry":"Belgium"
              },{
                "LocationFacility":"Chu D'Angers",
                "LocationCity":"Angers",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Saint Jacques",
                "LocationCity":"Besancon",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Pellegrin Enfants",
                "LocationCity":"Bordeaux",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Chu Estaing",
                "LocationCity":"Clermont Ferrand",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Henri Mondor",
                "LocationCity":"Creteil",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Chu Grenoble",
                "LocationCity":"Grenoble",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Chru Lille - Hop Jeanne de Flandres",
                "LocationCity":"Lille",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Institut Hematologie Oncologie Pediatrique",
                "LocationCity":"Lyon",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Institut Paoli Calmettes",
                "LocationCity":"Marseille",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Mere Enfant",
                "LocationCity":"Nantes",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hotel Dieu",
                "LocationCity":"Nantes",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital de L'Archet 2",
                "LocationCity":"Nice",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Armand Trousseau",
                "LocationCity":"Paris",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Robert Debre",
                "LocationCity":"Paris",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Saint Louis",
                "LocationCity":"Paris",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Haut-Leveque",
                "LocationCity":"Pessac",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Lyon Sud",
                "LocationCity":"Pierre Benite",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Chru Hopital Sud",
                "LocationCity":"Rennes",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Centre Henri Becquerel",
                "LocationCity":"Rouen",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Chu Hopital Nord",
                "LocationCity":"Saint Etienne",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Institut Cancerologie de La Loire",
                "LocationCity":"Saint Priest En Jarez",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital de Hautepierre",
                "LocationCity":"Strasbourg",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Chu de Toulouse Enfants",
                "LocationCity":"Toulouse",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hotel Dieu",
                "LocationCity":"Valenciennes",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital Brabois Enfants",
                "LocationCity":"Vandoeuvre Les Nancy",
                "LocationCountry":"France"
              },{
                "LocationFacility":"Hopital de Brabois",
                "LocationCity":"Vandoeuvre Les Nancy",
                "LocationCountry":"France"
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"Undecided"
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000001215",
                "InterventionMeshTerm":"Asparaginase"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M3103",
                "InterventionBrowseLeafName":"Asparaginase",
                "InterventionBrowseLeafAsFound":"Asparaginase",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M6651",
                "InterventionBrowseLeafName":"Erythromycin",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M6652",
                "InterventionBrowseLeafName":"Erythromycin Estolate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M16819",
                "InterventionBrowseLeafName":"Erythromycin Ethylsuccinate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M201972",
                "InterventionBrowseLeafName":"Erythromycin stearate",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007938",
                "ConditionMeshTerm":"Leukemia"
              },{
                "ConditionMeshId":"D000054198",
                "ConditionMeshTerm":"Precursor Cell Lymphoblastic Leukemia-Lymphoma"
              },{
                "ConditionMeshId":"D000007945",
                "ConditionMeshTerm":"Leukemia, Lymphoid"
              },{
                "ConditionMeshId":"D000012008",
                "ConditionMeshTerm":"Recurrence"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000008232",
                "ConditionAncestorTerm":"Lymphoproliferative Disorders"
              },{
                "ConditionAncestorId":"D000008206",
                "ConditionAncestorTerm":"Lymphatic Diseases"
              },{
                "ConditionAncestorId":"D000007160",
                "ConditionAncestorTerm":"Immunoproliferative Disorders"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              },{
                "ConditionAncestorId":"D000020969",
                "ConditionAncestorTerm":"Disease Attributes"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13433",
                "ConditionBrowseLeafName":"Recurrence",
                "ConditionBrowseLeafAsFound":"Relapse",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9528",
                "ConditionBrowseLeafName":"Leukemia",
                "ConditionBrowseLeafAsFound":"Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9534",
                "ConditionBrowseLeafName":"Leukemia, Lymphoid",
                "ConditionBrowseLeafAsFound":"Lymphoblastic Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M26172",
                "ConditionBrowseLeafName":"Precursor Cell Lymphoblastic Leukemia-Lymphoma",
                "ConditionBrowseLeafAsFound":"Acute Lymphoblastic Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9803",
                "ConditionBrowseLeafName":"Lymphoma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9808",
                "ConditionBrowseLeafName":"Lymphoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9786",
                "ConditionBrowseLeafName":"Lymphatic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8789",
                "ConditionBrowseLeafName":"Immunoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21284",
                "ConditionBrowseLeafName":"Disease Attributes",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T174",
                "ConditionBrowseLeafName":"Acute Lymphoblastic Leukemia",
                "ConditionBrowseLeafAsFound":"Acute Lymphoblastic Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T3546",
                "ConditionBrowseLeafName":"Lymphoblastic Lymphoma",
                "ConditionBrowseLeafAsFound":"Acute Lymphoblastic Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T3556",
                "ConditionBrowseLeafName":"Lymphosarcoma",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC15",
                "ConditionBrowseBranchName":"Blood and Lymph Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}