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NCT02257567 · OUTCOME

Phase Ib: AUC From Time Zero to Infinity (AUCinf) of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a

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: GEOMETRIC_MEAN
Unit: day*ug/mL
Interval / dispersion: Geometric Coefficient of Variation
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. The unit of measure for AUC is day\*micrograms per milliliter \[day\*ug/mL\]).

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

Groups in this outcome

Cohort 1a (Phase Ib Safety Run-In): Pola+BR 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 rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Cohort 1a (Phase Ib Safety Run-In): Pola+BR 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 rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 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 1a (Phase Ib Safety Run-In): Pola+BR in FL	4
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	6

Reported measurements

acMMAE

Analysis denominator · Participants

Group	Source count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	4
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	6

Values in day*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	2830	12.1	Not reported	Not reported	Not reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	2110	28.4	Not reported	Not reported	Not reported

Total Ab

Analysis denominator · Participants

Group	Source count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	4
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	6

Values in day*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL	298	4.9	Not reported	Not reported	Not reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL	214	35.9	Not reported	Not reported	Not reported

Unconjugated MMAE

Analysis denominator · Participants

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

Bendamustine

Analysis denominator · Participants

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

Rituximab

Analysis denominator · Participants

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

Complete source fields

classes

categories
measurements
group Id
OG000
spread
12.1
value
2830
group Id
OG001
spread
28.4
value
2110
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
6
units
Participants
title
acMMAE
categories
measurements
group Id
OG000
spread
4.9
value
298
group Id
OG001
spread
35.9
value
214
denoms
counts
group Id
OG000
value
4
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
Rituximab

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
6
units
Participants

description

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is day\*micrograms per milliliter \[day\*ug/mL\]).

dispersion Type

Geometric Coefficient of Variation

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 rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
id
OG000
title
Cohort 1a (Phase Ib Safety Run-In): Pola+BR 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 rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
id
OG001
title
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL

param Type

GEOMETRIC_MEAN

population Description

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

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: AUC From Time Zero to Infinity (AUCinf) of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a

type

SECONDARY

unit Of Measure

day*ug/mL

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Preserved source evidence · Not medical advice