{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Acute Graft versus Host Disease (aGvHD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Sepsis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Infection"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"Graft Failure"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Cardiac"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Multi-organ failure"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Hepatic Veno-Occlusive Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Post-transplant lymphoproliferative disorder"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Acute respiratory distress syndrome"}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"}],"units":"Participants"}],"description":"Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.","groups":[{"description":"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors\n\nDonor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.\n\nPreparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.\n\nPatient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45.","id":"OG000","title":"Campath Purged Non-myeloablative ASCT"}],"paramType":"NUMBER","populationDescription":"Cohort of subjects on the study who received \\>/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.","reportingStatus":"POSTED","timeFrame":"1 year","title":"Toxicity","type":"PRIMARY","unitOfMeasure":"participants"}