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NCT02933320 · OUTCOME

Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206.

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.

Measure
NUMBER
Unit
Number of events
Interval / dispersion
Not reported
Time frame
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.

What was measured

To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients.

Analysis population: Safety population

Groups in this outcome

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

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.

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

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.

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

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.

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

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase13
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase1
Part B: Arm1: BI-1206 Single Agent Expansion Phase0
Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase0

Reported measurements

All AEs
Values in Number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase282Not reportedNot reportedNot reportedNot reported
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase13Not reportedNot reportedNot reportedNot reported
Related AEs
Values in Number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase214Not reportedNot reportedNot reportedNot reported
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase12Not reportedNot reportedNot reportedNot reported
DLT - ALT
Values in Number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase1Not reportedNot reportedNot reportedNot reported
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase0Not reportedNot reportedNot reportedNot reported
DLT - AST
Values in Number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase1Not reportedNot reportedNot reportedNot reported
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase0Not reportedNot reportedNot reportedNot reported
DLT - infusion related reaction
Values in Number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase0Not reportedNot reportedNot reportedNot reported
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        282
      2. group Id
        OG001
        value
        13
    title
    All AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        214
      2. group Id
        OG001
        value
        12
    title
    Related AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    DLT - ALT
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    DLT - AST
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    DLT - infusion related reaction
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients.
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
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    title
    Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase
param Type
NUMBER
population Description
Safety population
reporting Status
POSTED
time Frame
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 Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206.
type
PRIMARY
unit Of Measure
Number of events

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Preserved source evidence · Not medical advice