NCT02933320 · OUTCOME

Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From first BI-1206 administration up to 12 months

What was measured

To measure the time to disease progression and twelve month survival

Analysis population: Progression free survival 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

Group	Source count
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase	13
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase	1
Part B: Arm1: BI-1206 Single Agent Expansion Phase	0
Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase	0

Reported measurements

Progression free & alive

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase	2	Not reported	Not reported	Not reported	Not reported
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase	0	Not reported	Not reported	Not reported	Not reported

Progressed, died or unknown

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase	11	Not reported	Not reported	Not reported	Not reported
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Progression free & alive
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
1
title
Progressed, died or unknown

denoms

counts
group Id
OG000
value
13
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
units
Participants

description

To measure the time to disease progression and twelve month survival

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). 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
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
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
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

COUNT_OF_PARTICIPANTS

population Description

Progression free survival population

reporting Status

POSTED

time Frame

From first BI-1206 administration up to 12 months

title

Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice