{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"To identify the recommended phase 2 dose (RP2D)/maximum tolerated dose (MTD) of brentuximab vedotin in combination with rituximab. The dose limiting toxicity monitoring period for brentuximab vedotin and rituximab is first 21 days (during induction).The RP2D/MTD will be defined as the highest dose of brentuximab vedotin that causes dose limiting toxicities (DLTs) in \\<2 of 6 patients. The Phase I portion of the study follows a 3+3 design. Brentuximab has two dose levels: Level 1 (starting dose) 1.2 mg/kg IV, and Level -1 (de-escalation dose): 0.8 mg/kg IV. Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03.","groups":[{"description":"Induction:\n\n* Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks\n* Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks)\n\nConsolidation (optional): Identical to Induction.\n\nMaintenance:\n\n* Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease.\n* Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.","id":"OG000","title":"Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"The first 21 days of Induction","title":"For Phase I: The Recommended Phase 2 Dose of Brentuximab Vedotin in Combination With Rituximab.","type":"PRIMARY","unitOfMeasure":"mg/kg"}