Participant flow

BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia · Source last updated 2021-07-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. 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). BI-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

   FG000

   title

   Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase

2. 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). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.

   id

   FG001

   title

   Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase

3. 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. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.

   id

   FG002

   title

   Part B: Arm1: BI-1206 Single Agent Expansion Phase

4. 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. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.

   id

   FG003

   title

   Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         1

      3. comment

         Trial terminated early

         group Id

         FG002

         num Subjects

         0

      4. comment

         Trial terminated early

         group Id

         FG003

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Trial participants were enrolled at four trial sites between 27 October 2016 and 09 December 2019.

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Preserved source evidence · Not medical advice