{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Stable disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"0"}]}],"title":"Progressive disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"title":"Not evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"To look for signs of anti-tumour activity of BI-1206 alone and in combination 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":"COUNT_OF_PARTICIPANTS","populationDescription":"Response population","reportingStatus":"POSTED","timeFrame":"Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study.","title":"Assessment of Best Disease Response According to Criteria for Malignant Lymphoma (Cheson, 2014) Waldenström Macroglobulinaemia Assessment Criteria (Owen 2013, Kimby 2006) or NCI Chronic Lymphocytic Leukaemia (CLL) Criteria (Hallek, 2008).","type":"SECONDARY","unitOfMeasure":"Participants"}