{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"Clinical Stage of acute GVHD according to Organ System\n\nSkin:\n\n1. \\- Maculopapular rash \\<25% of body surface\n2. \\- Maculopapular rash 25-50% of body surface\n3. \\- Maculopapular rash \\>50% body surface area or generalized erythroderma\n4. \\- Generalized erythroderma with bullous formation and desquamation\n\nLiver:\n\n1. \\- Bilirubin 2-3 mg/dl\n2. \\- Bilirubin 3.1-6 mg/dl\n3. \\- Bilirubin 6.1-15 mg/dl\n4. \\- Bilirubin \\>15 mg/dl\n\nGut:\n\n1. \\- \\>500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD\n2. \\- \\>1000 -1500 mL diarrhea per day\n3. \\- \\>1500 mL diarrhea per day\n4. \\- \\>1500 mL diarrhea per day plus severe abdominal pain with or without ileus\n\nOverall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI","groups":[{"description":"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"OG000","title":"Group 1A (Pentostatin, DLI Dose Level 1)"},{"description":"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"OG001","title":"Group 1B (Pentostatin, DLI Dose Level 2)"},{"description":"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"OG002","title":"Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)"},{"description":"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"OG003","title":"Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)"}],"paramType":"NUMBER","populationDescription":"No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.","reportingStatus":"POSTED","timeFrame":"Within 100 days after the last DLI","title":"Incidence of Grade IV Acute GVHD","type":"PRIMARY","unitOfMeasure":"percentage of participants"}