Baseline characteristics

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.

denoms

1. counts

   1. group Id

      BG000

      value

      13

   2. group Id

      BG001

      value

      1

   3. group Id

      BG002

      value

      0

   4. group Id

      BG003

      value

      0

   5. group Id

      BG004

      value

      14

   units

   Participants

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

   BG000

   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

   BG001

   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

   BG002

   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

   BG003

   title

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

5. description

   Total of all reporting groups

   id

   BG004

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG004

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            5

         2. group Id

            BG001

            value

            1

         3. group Id

            BG004

            value

            6

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            8

         2. group Id

            BG001

            value

            0

         3. group Id

            BG004

            value

            8

         title

         >=65 years

      denoms

      1. counts

         1. group Id

            BG000

            value

            13

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            0

         4. group Id

            BG003

            value

            0

         5. group Id

            BG004

            value

            14

         units

         Participants

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Age, Categorical

   unit Of Measure

   Participants

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            5

         2. group Id

            BG001

            value

            1

         3. group Id

            BG004

            value

            6

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            8

         2. group Id

            BG001

            value

            0

         3. group Id

            BG004

            value

            8

         title

         Male

      denoms

      1. counts

         1. group Id

            BG000

            value

            13

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            0

         4. group Id

            BG003

            value

            0

         5. group Id

            BG004

            value

            14

         units

         Participants

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG004

            value

            0

      denoms

      1. counts

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         4. group Id

            BG003

            value

            0

         5. group Id

            BG004

            value

            0

         units

         Participants

   param Type

   COUNT_OF_PARTICIPANTS

   population Description

   Race and Ethnicity were not collected from any participant.

   title

   Race and Ethnicity Not Collected

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            13

         2. group Id

            BG001

            value

            1

         3. group Id

            BG004

            value

            14

      denoms

      1. counts

         1. group Id

            BG000

            value

            13

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            0

         4. group Id

            BG003

            value

            0

         5. group Id

            BG004

            value

            14

         units

         Participants

      title

      United Kingdom

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

population Description

Trial terminated before opening Part B.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice