{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"comment":"50 mg BI-1206 given but not rituximab","groupId":"OG001","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"Establishing the MTD or maximum administered dose MAD of BI-1206 and an anti-CD20 antibody given once weekly for four weeks, via intravenous infusion in patients with relapsed or refractory B-cell malignancies.","groups":[{"description":"BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).\n\nBI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.","id":"OG000","title":"Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase"},{"description":"Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).\n\nCombination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.","id":"OG001","title":"Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase"},{"description":"Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.\n\nBI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.","id":"OG002","title":"Part B: Arm1: BI-1206 Single Agent Expansion Phase"},{"description":"Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.\n\nCombination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.","id":"OG003","title":"Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab.","title":"Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody.","type":"PRIMARY","unitOfMeasure":"BI-1206 MAD (mg)"}