{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"72"},{"groupId":"OG003","value":"10"}],"units":"Participants"}],"description":"Each event of infection will be assessed to determine whether or not it is clinically significant. An infection is defined as clinically significant when it is scored as ≥ grade 3 (where worse outcomes are associated with higher grading) in accordance with the CTCAE version 3.0/protocol Appendix VI, and constitutes a Serious Adverse Event (SAE). Monitoring will take place separately for the single and double UCBT cohorts.","groups":[{"description":"Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0.\n\nFludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT\n\nPatients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \\> day 30) after engraftment if there continues to be no evidence of acute GVHD.\n\nCyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies","id":"OG000","title":"Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant"},{"description":"Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0.\n\nFludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT\n\nPatients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \\> day 30) after engraftment if there continues to be no evidence of acute GVHD.\n\nCyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies","id":"OG001","title":"Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant"},{"description":"Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0.\n\nFludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT\n\nPatients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \\> day 30) after engraftment if there continues to be no evidence of acute GVHD.\n\nCyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies","id":"OG002","title":"Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant"},{"description":"Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0.\n\nFludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT\n\nPatients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \\> day 30) after engraftment if there continues to be no evidence of acute GVHD.\n\nCyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies","id":"OG003","title":"Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant"}],"paramType":"NUMBER","populationDescription":"Participants who received UCBT on study.","reportingStatus":"POSTED","timeFrame":"Up to 2 years post-transplant","title":"Event of Clinically Significant Infections","type":"SECONDARY","unitOfMeasure":"events"}