{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"description":"A classic 3+3 dose-escalation design was used to assess the MTD of siplizumab in combination with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). If 2 of 6 patients experienced a dose-limiting toxicity (DLT) at a particular dose level, the MTD has been exceeded. The preceding dose level will be the MTD, provided 6 patients have been entered at this level and no more than one has experienced a DLT. DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an Epstein Barr Virus (EBV)-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted EPOCH-R and grade 3 laboratory adverse events (AEs) were not considered to be DLTs.","groups":[{"description":"All participants who received 3.4 mg/kg, 4.8 mg/kg, 8.5 mg/kg and 15 mg/kg siplizumab given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.","id":"OG000","title":"All Participants"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"First 30 days after treatment initiation.","title":"Maximum Tolerated Dose (MTD) of Siplizumab","type":"PRIMARY","unitOfMeasure":"mg/kg"}