{
  "FullStudy":{
    "Rank":217748,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517347",
          "OrgStudyIdInfo":{
            "OrgStudyId":"PUPH IRB [2012] (09）"
          },
          "Organization":{
            "OrgFullName":"Peking University People's Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation",
          "OfficialTitle":"Low Dose of Interleukin-2 Following Allogeneic Unmanipulated Blood and Marrow Transplantation in Treating Patients With Standard Risk Hematologic Malignancy"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2016",
          "OverallStatus":"Terminated",
          "WhyStopped":"Because the conditional power was 0.083, the Data and Safety Monitoring Board recommended halting the study due to futility after the 1st interim analysis.",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 20, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 24, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Xiaojun Huang",
            "ResponsiblePartyInvestigatorTitle":"Chief of Peking University Institute of Hematology",
            "ResponsiblePartyInvestigatorAffiliation":"Peking University People's Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Peking University People's Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, relapse rate was still the key question to influence the overall survival after transplantation, even in standard risk leukemia.There were good evidences that natural killer cells and T regulatory cells, which were expanded and stimulated by the application of IL-2, could mediate protection against GvHD while maintaining graft anti-tumor activity as a positive side effect. Meanwhile, it was found in our previous pilot study that low-dose IL-2 subcutaneous administration from 100 days for a prolonged period could be a safe and effective strategy to prevent relapse in acute lymphoblastic malignancy patients with high risk of recurrence after unmanipulated allo-HSCT.\n\nThe study hypothesis:\n\nPrevention of relapse using low dose IL-2 following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can\n\nreduce relapse rate\nimprove survival",
          "DetailedDescription":"Standard risk patients over 15 years old(except Ph+ ALL, AML t(8;21) and T-ALL) undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation were randomized into treated group (with low dose IL-2 treatment) or controlled group (without any intervention post-transplantation). The end points were safety and clinical and immunologic response.Following time is 24 months.\n\nPrimary Outcome Measures:\n\n*To determine the feasibility and efficacy of administering an 6 course of subcutaneous IL-2 in this patient population. [ Time Frame: 2 years ]\n\nSecondary Outcome Measures:\n\n*To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation [ Time Frame: 2 years ] Estimated Enrollment:360 Study Start Date:Jan 2012 Estimated Study Completion Date:Jan 2016\n\nIntervention Details Description:\n\n*Drug: Interleukin-2 Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.\n\nDetailed Description:\n\nPatients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.\nParticipants will be seen periodically while they are receiving IL-2. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until the completion of 6 course therapy.\n\nEligibility Ages Eligible for Study:15 Years and older Genders Eligible for Study:Both Accepts Healthy Volunteers:No Criteria\n\nInclusion Criteria:\n\nStandard risk of Recipients of allogeneic stem cell transplantation with myeloablative conditioning regimens\nStandard risk of Recipients: CR1 or CR 2 of AML/ALL before transplantation\nPh+ ALL，AML with t(8;21) and T-ALL were excepted\nPatients were at least 60 days post-transplantation\nBone marrow monitoring was still Complete Remission (CR) and minor residual disease (MRD) was negative\n15 years of age or older\nNo serious infection\n\nExclusion Criteria:\n\nExposure to any other clinical trials prior to enrollment\nActive malignant disease relapse\nActive, uncontrolled infection\nInability to comply with IL-2 treatment regimen"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Leukemia"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "IL2",
              "relapse",
              "GVHD",
              "survival",
              "allogeneic stem cell transplantation",
              "MRD",
              "CR"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"90",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Interleukin-2",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Interleukin-2 post-transplantation to prevent relapse of standard risk leukemia",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Interleukin-2"
                  ]
                }
              },{
                "ArmGroupLabel":"controlled group",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"controlled standard risk leukemia received regular transplantation without IL-2 intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Interleukin-2",
                "InterventionDescription":"Patients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Interleukin-2"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "IL-2"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"To determine the feasibility and efficiency of administering 6 courses of subcutaneous IL-2 in these patients population.",
                "PrimaryOutcomeDescription":"investigate the incidences of severe GVHD and pancytopenia after IL-2 application to evaluate the safety of this drug.\n\nobserve the drug toxicity based on common toxicity criteria (CTC,version 3.0). compare the relapse rate and incidence of positive MRD between two groups to evaluate the efficiency of IL-2 application.",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation",
                "SecondaryOutcomeDescription":"examine the immune reconstitution of subgroups of T cells after IL-2 application and compare with that of controlled group of patients.",
                "SecondaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nStandard risk of Recipients (CR1 or CR 2 of AML/ALL before transplantation except Ph+ ALL and T-ALL) of allogeneic stem cell transplantation with myeloablative conditioning regimens\nStandard risk of Recipients: CR1 or CR 2 of AML/ALL before transplantation\nPh+ ALL, AML with t(8;21) and T-ALL were excepted\nPatients were at least 60 days post-transplantation\nBone marrow monitoring was still Complete Remission (CR) and minor residual disease (MRD) was negative\n15 years of age or older\nNo serious infection\n\nExclusion Criteria:\n\nExposure to any other clinical trials prior to enrollment\nActive malignant disease relapse\nActive, uncontrolled infection\nInability to comply with IL-2 treatment regimen",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"15 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Xiaojun Huang, MD",
                "OverallOfficialAffiliation":"Peking University Institute of Hematology",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Xiaosu Zhao",
                "LocationCity":"Beijing",
                "LocationState":"Beijing",
                "LocationZip":"100044",
                "LocationCountry":"China"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000007376",
                "InterventionMeshTerm":"Interleukin-2"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000018712",
                "InterventionAncestorTerm":"Analgesics, Non-Narcotic"
              },{
                "InterventionAncestorId":"D000000700",
                "InterventionAncestorTerm":"Analgesics"
              },{
                "InterventionAncestorId":"D000018689",
                "InterventionAncestorTerm":"Sensory System Agents"
              },{
                "InterventionAncestorId":"D000018373",
                "InterventionAncestorTerm":"Peripheral Nervous System Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M8994",
                "InterventionBrowseLeafName":"Interleukin-2",
                "InterventionBrowseLeafAsFound":"Interleukin-2",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2613",
                "InterventionBrowseLeafName":"Analgesics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19370",
                "InterventionBrowseLeafName":"Analgesics, Non-Narcotic",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Analg",
                "InterventionBrowseBranchName":"Analgesics"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007938",
                "ConditionMeshTerm":"Leukemia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9528",
                "ConditionBrowseLeafName":"Leukemia",
                "ConditionBrowseLeafAsFound":"Leukemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M19898",
                "ConditionBrowseLeafName":"Hematologic Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC15",
                "ConditionBrowseBranchName":"Blood and Lymph Conditions"
              }
            ]
          }
        }
      }
    }
  }
}