{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5","upperLimit":"28","value":"16"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"}],"units":"Participants"}],"description":"Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \\~35% to \\~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.","dispersionType":"95% Confidence Interval","groups":[{"description":"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.\n\nTRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.\n\nGVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.\n\ncyclophosphamide: Given IV\n\ncyclosporine: Given IV\n\nperipheral blood stem cell transplantation: Undergo allogeneic PBSCT\n\ntotal-body irradiation: Undergo TBI\n\nfludarabine phosphate: Given IV\n\nbusulfan: Given IV\n\nallogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT","id":"OG000","title":"Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"At 1 year after transplantation","title":"Chronic GVHD Requiring Systemic Immunosuppressive Treatment","type":"PRIMARY","unitOfMeasure":"percent of patients"}