{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"120"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"RP2D was determined by a traditional 3+3 dose escalation design, with the following restrictions: only doses of 60, 90, 120, and 150 mg/m\\^2 were explored, and escalation to 150 mg/m\\^2 would only occur if the 120 mg/m\\^2 dose was deemed safe and pharmacokinetic data indicate subtherapeutic exposure as compared with adults. The first cohort was administered bendamustine at the 90 mg/m\\^2 dose; de-escalation to the 60 mg/m\\^2 dose would only occur if the starting dose led to dose-limiting toxicity (DLT) in 2 or more participants. A DLT was defined as any study drug-related nonhematologic adverse event (AE) that was grade 4 for toxicity by National Cancer Institute's Common Toxicity Criteria for AEs, version 4. In addition, grade 3 or above allergic reaction or skin rash were considered DLTs. Hematologic AEs were not considered DLTs. The dose level at which at least 2 of 3 or 2 of 6 participants had a DLT was considered as exceeding the RP2D. The RP2D was the dose 1 step below that level.","groups":[{"description":"Bendamustine 90 or 120 mg/m\\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.","id":"OG000","title":"Phase 1: Bendamustine 90 or 120 mg/m^2"}],"paramType":"NUMBER","populationDescription":"All participants enrolled in Phase 1 of the study.","reportingStatus":"POSTED","timeFrame":"Induction Cycle (21- to 35-day cycle)","title":"Recommended Phase II Dose (RP2D) of Bendamustine","type":"PRIMARY","unitOfMeasure":"mg/m^2"}