{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Dose Level 1: (.08 mg/kg), n=6"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Dose Level 2: (.16 mg/kg), n=6"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Dose Level 3: (.32 mg/kg), n=6"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Dose Level 4: (.48 mg/kg), n=12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following:\n\n* Absolute neutrophil counts or platelet counts below 10\\*10\\^9/L for 14 days\n* Absolute neutrophil counts greater than 0.5 or less than 1\\*10\\^9/L\n* Platelet counts greater than 10 or less than 50\\*10\\^9/L for 28 days.\n* Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.\n\nWe are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity.","groups":[{"description":"Phase I patients will receive the following treatment:\n\n* 250 mg/m\\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle\n* 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1\n* 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8\n* CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.\n* 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15","id":"OG000","title":"Phase I"},{"description":"Phase II patients will receive the following treatment:\n\n* 250 mg/m\\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle\n* 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8\n* 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.\n* 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15","id":"OG001","title":"Phase II"}],"paramType":"NUMBER","populationDescription":"Only participants accrued to the Phase I portion of this study were used to determine the maximum tolerated dose.","reportingStatus":"POSTED","timeFrame":"at least 10 weeks post treatment up to 3 months.","title":"Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level","type":"PRIMARY","unitOfMeasure":"participants"}