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NCT02257567 · OUTCOME

Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma · Source last updated 2022-11-14

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

Measure: MEAN
Unit: mL/kg
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

What was measured

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Analysis population: PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and obinutuzumab.

Groups in this outcome

Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL

Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL

Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

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
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	6

Reported measurements

acMMAE

Analysis denominator · Participants

Group	Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	5
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	6

Values in mL/kg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	77.2	38.8	Not reported	Not reported	Not reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	64.7	23.0	Not reported	Not reported	Not reported

Total Ab

Analysis denominator · Participants

Group	Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	6

Values in mL/kg · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	87.5	38.5	Not reported	Not reported	Not reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	87.9	24.7	Not reported	Not reported	Not reported

Unconjugated MMAE

Analysis denominator · Participants

Group	Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	0

Bendamustine

Analysis denominator · Participants

Group	Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	0

Obinutuzumab

Analysis denominator · Participants

Group	Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL	0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL	0

Complete source fields

classes

categories
measurements
group Id
OG000
spread
38.8
value
77.2
group Id
OG001
spread
23.0
value
64.7
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
6
units
Participants
title
acMMAE
categories
measurements
group Id
OG000
spread
38.5
value
87.5
group Id
OG001
spread
24.7
value
87.9
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
6
units
Participants
title
Total Ab
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
units
Participants
title
Unconjugated MMAE
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
units
Participants
title
Bendamustine
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
units
Participants
title
Obinutuzumab

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
6
units
Participants

description

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

dispersion Type

Standard Deviation

groups

description
Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
id
OG000
title
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
description
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
id
OG001
title
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL

param Type

MEAN

population Description

PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and obinutuzumab.

reporting Status

POSTED

time Frame

Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

title

Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b

type

SECONDARY

unit Of Measure

mL/kg

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Preserved source evidence · Not medical advice