{ "FullStudy":{ "Rank":217686, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518153", "OrgStudyIdInfo":{ "OrgStudyId":"2011-1104" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"NCI-2012-00131", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"NCI CTRP" } ] }, "Organization":{ "OrgFullName":"M.D. Anderson Cancer Center", "OrgClass":"OTHER" }, "BriefTitle":"Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)", "OfficialTitle":"Phase 2 Study of Planned Donor Lymphocyte Infusion After Reduced Intensity Allogeneic Stem Cell Transplantation" }, "StatusModule":{ "StatusVerifiedDate":"February 2016", "OverallStatus":"Terminated", "WhyStopped":"Objectives not met.", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 22, 2016", "ResultsFirstSubmitQCDate":"February 18, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 17, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 18, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 17, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"M.D. Anderson Cancer Center", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. This will be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma. These results are measured as helping to control the disease without severe graft-versus-host disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's body.\n\nFludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants:\n\nFludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die.\nMelphalan is designed to bind to the DNA of cells, which may cause cancer cells to die.\nAlemtuzumab is designed to weaken the immune system and reduce the risk of rejection of the transplant and graft-vs-host disease (GvHD).\n\nThe donor infusion of T-cells is designed to help restore the immune system after the transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer coming back.", "DetailedDescription":"Study Groups:\n\nIf you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups involving the dose of T-cells in the donor lymphocyte infusion.\n\nGroup 1 will receive a low dose of donor T-cells.\nGroup 2 will receive a higher dose of donor T-cells than Group 1.\n\nBoth you and your study doctor will know which group you are in. Both groups will have a stem cell transplant. The stem cells will be given by vein. The cells will travel to your bone marrow where they are designed to make healthy, new blood cells after several weeks.\n\nStudy Drug Administration:\n\nPatients receive fludarabine, melphalan and alemtuzumab to kill malignant cells and suppress immunity to prevent rejection of the stem cell transplant. The day you receive the stem cells is called Day 0. The days before you receive your stem cells are called minus days. The days after you receive the stem cells are called plus days.\n\nOn Day -7, you will be admitted to the hospital and given fluids by vein to hydrate you.\n\nOn Days -6 through -3, you will receive fludarabine by vein over 1 hour each day.\n\nOn Day -2, you will receive melphalan by vein over 30 minutes.\n\nOn Day -1, you will receive alemtuzumab by vein over 2 hours.\n\nOn Day 0, you will receive the stem cell transplant as a cell infusion by vein.\n\nAfter the transplant, you will receive tacrolimus and methotrexate. At first, you will receive tacrolimus as a continuous (nonstop) infusion until you are able to take it by mouth. You will then take tacrolimus by mouth 2 times a day for about 5 weeks and then your doctor will tell you how to taper it off (gradually stop taking it). On Days 1, 3, and 6 after the transplant, you will receive methotrexate by vein over 30 minutes.\n\nYou will receive filgrastim as an injection under the skin 1 time a day, starting 1 week after the transplant, until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.\n\nBetween Day +56 and +64, if you are in stable medical condition and have not developed GvHD, you will receive a donor lymphocyte infusion containing T-cells by vein over 10-30 minutes. You will receive Benadryl (diphenhydramine) by vein over 15 minutes before the infusion to lower the risk of an allergic reaction.\n\nStudy Visits:\n\nBefore the T-cell infusion:\n\nYou will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).\nYou will be asked about how you are feeling and about any side effects you may be having.\nBlood (about 2 teaspoons) will be drawn to see how well the transplant has \"taken\".\nYou will have a bone marrow aspiration and biopsy to check the status of the disease, if your doctor thinks it is needed. To collect a bone marrow aspiration/biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.\n\nAfter the T-cell infusion, you will have a physical exam every week for at least 6 weeks.\n\nAbout 3, 6, and 12 months after the transplant:\n\nYou will have a physical exam, including measurement of your vital signs.\nYou will be asked about how you are feeling and about any side effects you may be having.\nBlood (about 4 tablespoons) will be drawn for routine tests and to check the level of the infused T-cells, for immune function tests, and to check the status of the disease.\nYou will have a bone marrow aspiration, blood tests and CT scans as medically necessary to check the status of the disease, if your doctor thinks it is needed.\n\nDuring the study, you will have blood draws (about 2 teaspoons) and urine will be collected for routine tests, to check your blood counts, kidney and liver function, and/or to check for infections as often as the doctor thinks is needed during this time.\n\nLength of Treatment:\n\nYou will be off study after your 12-month follow-up visit. You will be taken off study early if you have graft failure (the donor cells did not \"take\") or if the cancer comes back and needs another treatment.\n\nThis is an investigational study. Melphalan, fludarabine, and alemtuzumab are FDA approved and commercially available for the treatment of blood cancers. Donor T-cell infusions are commonly used to treat blood cancers that come back after a stem cell transplant. The investigational part of this study is to find the best dose of T-cells that are given with the goal of helping to prevent the cancer from coming back.\n\nUp to 56 patients will take part in this study. All will be enrolled at MD Anderson." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Leukemia", "Lymphoma", "Myeloma", "Myeloproliferative Diseases" ] }, "KeywordList":{ "Keyword":[ "Blood and Marrow Transplantation", "Lymphoma", "Myeloma", "Myeloproliferative Diseases", "Leukemia", "Myelodysplastic syndrome", "MDS", "Hodgkin disease", "Multiple myeloma", "Fludarabine", "Fludarabine Phosphate", "Fludara", "Melphalan", "Alkeran", "Tacrolimus", "Prograf", "Methotrexate", "G-CSF", "Filgrastim", "NeupogenTM", "Donor Lymphocyte Infusion", "DLI", "Allogeneic Stem Cell Transplantation", "Graft-vs-host disease", "GvHD", "T-lymphocytes", "T-cells", "Alemtuzumab", "CAMPATH-1H", "Campath" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"16", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Low Dose Donor T-Cells", "ArmGroupType":"Experimental", "ArmGroupDescription":"Fludarabine 40 mg/m^2 by vein on Day -6 to -3. Melphalan 140 mg/m^2 by vein on Day -2. Alemtuzumab 50 mg by vein on Day -1. Reduced intensity stem cell transplant on Day 0. Planned Donor Lymphocyte Infusion CD3+ cells: 3 * 106 CD3+ cells/kg between Day +56 and +64. Tacrolimus 0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35. Methotrexate 5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fludarabine", "Drug: Melphalan", "Drug: Alemtuzumab", "Procedure: Stem Cell Infusion", "Drug: Tacrolimus", "Drug: Methotrexate", "Drug: G-CSF", "Procedure: Low Dose Donor T-Cells" ] } },{ "ArmGroupLabel":"High Dose Donor T-Cells", "ArmGroupType":"Experimental", "ArmGroupDescription":"Fludarabine 40 mg/m^2 by vein on Day -6 to -3. Melphalan 140 mg/m^2 by vein on Day -2. Alemtuzumab 50 mg by vein on Day -1. Reduced intensity stem cell transplant on Day 0. High Dose Donor T-Cells Planned Donor Lymphocyte Infusion CD3+ cells: 1 * 107 CD3+ cells/kg between Day +56 and +64. Tacrolimus 0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35. Methotrexate 5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Fludarabine", "Drug: Melphalan", "Drug: Alemtuzumab", "Procedure: Stem Cell Infusion", "Drug: Tacrolimus", "Drug: Methotrexate", "Drug: G-CSF", "Procedure: High Dose Donor T-Cells" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Fludarabine", "InterventionDescription":"40 mg/m^2 by vein on Day -6 to -3.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose Donor T-Cells", "Low Dose Donor T-Cells" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Fludarabine Phosphate", "Fludara" ] } },{ "InterventionType":"Drug", "InterventionName":"Melphalan", "InterventionDescription":"140 mg/m^2 by vein on Day -2.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose Donor T-Cells", "Low Dose Donor T-Cells" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Alkeran" ] } },{ "InterventionType":"Drug", "InterventionName":"Alemtuzumab", "InterventionDescription":"50 mg by vein on Day -1.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose Donor T-Cells", "Low Dose Donor T-Cells" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "CAMPATH-1H", "Campath" ] } },{ "InterventionType":"Procedure", "InterventionName":"Stem Cell Infusion", "InterventionDescription":"Reduced intensity stem cell transplant on Day 0.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose Donor T-Cells", "Low Dose Donor T-Cells" ] } },{ "InterventionType":"Drug", "InterventionName":"Tacrolimus", "InterventionDescription":"0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose Donor T-Cells", "Low Dose Donor T-Cells" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Prograf" ] } },{ "InterventionType":"Drug", "InterventionName":"Methotrexate", "InterventionDescription":"5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose Donor T-Cells", "Low Dose Donor T-Cells" ] } },{ "InterventionType":"Drug", "InterventionName":"G-CSF", "InterventionDescription":"5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose Donor T-Cells", "Low Dose Donor T-Cells" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Filgrastim", "NeupogenTM" ] } },{ "InterventionType":"Procedure", "InterventionName":"Low Dose Donor T-Cells", "InterventionDescription":"Planned Donor Lymphocyte Infusion CD3+ cells: 3 * 106 CD3+ cells/kg between Day +56 and +64.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Low Dose Donor T-Cells" ] } },{ "InterventionType":"Procedure", "InterventionName":"High Dose Donor T-Cells", "InterventionDescription":"Planned Donor Lymphocyte Infusion CD3+ cells: 1 * 107 CD3+ cells/kg between Day +56 and +64.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High Dose Donor T-Cells" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Success Rate", "PrimaryOutcomeDescription":"Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).", "PrimaryOutcomeTimeFrame":"100 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Overall Survival (OS)", "SecondaryOutcomeDescription":"Overall Survival is defined as the interval between day of transplant and day of death.", "SecondaryOutcomeTimeFrame":"Every 3 months until day of death" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge >/= 18 years and 40 ml/min (based on serum creatinine)\nBilirubin <1.5 mg/dl except for Gilbert's disease.\nALT < 300 IU/ml d.\nLeft ventricular ejection fraction equal or greater than 40%.\nPulmonary function test (PFT) demonstrating a diffusion capacity (corrected for hemoglobin) of least 50% predicted.\nPatient or patient's legal representative able to sign informed consent.\n\nExclusion Criteria:\n\nPatients who have had prior autologous transplants or prior allogeneic transplants are not eligible.\nUncontrolled active infection.\nPositive Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.\nWomen of child bearing potential not willing to use an effective contraceptive measure while on study.\nSubject has known sensitivity to any of the products that will be administered during the study.\nPatients who are HIV seropositive.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Richard E. Champlin, MD,BS", "OverallOfficialAffiliation":"M.D. Anderson Cancer Center", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of Texas MD Anderson Cancer Center", "LocationCity":"Houston", "LocationState":"Texas", "LocationZip":"77030", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"University of Texas MD Anderson Cancer Center Website", "SeeAlsoLinkURL":"http://www.mdanderson.org" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned Donor Lymphocyte Infusion (DLI). 9 participants did not meet the criteria to receive randomized planned DLI.", "FlowRecruitmentDetails":"Recruitment Period: February 6, 2012 to February 27, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Stem Cell Infusion", "FlowGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Low Dose Donor T-Cells", "FlowGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"High Dose Donor T-Cells", "FlowGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Stem Cell Transplant", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Active graft-vs-host disease (GvHD)", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Secondary graft failure", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Donor Lymphocyte Infusion", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"3" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Stem Cell Transplant + Donor Lymphocyte Infusion", "BaselineGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"16" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"58", "BaselineMeasurementLowerLimit":"35", "BaselineMeasurementUpperLimit":"65" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Success Rate", "OutcomeMeasureDescription":"Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).", "OutcomeMeasurePopulationDescription":"Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI. 9 participants did not meet the criteria to receive randomized planned DLI.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"100 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Low Dose Donor T-Cells", "OutcomeGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"High Dose Donor T-Cells", "OutcomeGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"3" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Overall Survival (OS)", "OutcomeMeasureDescription":"Overall Survival is defined as the interval between day of transplant and day of death.", "OutcomeMeasurePopulationDescription":"Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"Every 3 months until day of death", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Stem Cell Transplant + Donor Lymphocyte Infusion", "OutcomeGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"246", "OutcomeMeasurementLowerLimit":"26", "OutcomeMeasurementUpperLimit":"504" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events (AEs) were collected from the start of preparative regimen up to discontinuation of study treatment. Overall collection period: March 30, 2012 to April 15, 2014.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Stem Cell Infusion", "EventGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.", "EventGroupSeriousNumAffected":"9", "EventGroupSeriousNumAtRisk":"9", "EventGroupOtherNumAffected":"9", "EventGroupOtherNumAtRisk":"9" },{ "EventGroupId":"EG001", "EventGroupTitle":"Low Dose Donor T-Cells", "EventGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"3", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"3" },{ "EventGroupId":"EG002", "EventGroupTitle":"High Dose Donor T-Cells", "EventGroupDescription":"Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.", "EventGroupSeriousNumAffected":"4", "EventGroupSeriousNumAtRisk":"4", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"4" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Death", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Idiopathic Thrombocytopenic Purpura", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Pneumonia", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Secondary Graft Failure", "SeriousEventOrganSystem":"Immune system disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Enterococcus Faecium Stool Infection", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Parvovirus", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Disseminated Cytomegalovirus Infections", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Pseudomonas Bacteremia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Viral Exanthem", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Deep Vein Thrombosis", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"Suspected due to preparatory regimen", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Liver GvHD", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Pneumocystis Jiroveci (PCP) Pneumonia", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Fusarium Pneumonia", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Pulmonary Nocardiosis", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Pseudomonas Pneumonia", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Neutropenic Fevers", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Staphylococcus Epidermidis Bacteremia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Candida Albicans", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Escherichia Coli Urinary Tract Infection", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Staphylococcus Urinary Tract Infection", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Acute Tubular Necrosis", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"Pre-existing renal insufficiency", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Pseudomonas Tracheitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Anoxic Brain Injury", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Diffuse Alveolar Hemorrhage", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"BK Virus Associated Hemorrhagic Cystitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"Adenovirus Viremia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" } ] } },{ "SeriousEventTerm":"HSV Viremia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"CTCAE (3.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ 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