NCT02257567 · OUTCOME

Phase II: CL of Bendamustine and Rituximab in Arms B and D

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: L/h
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)

Analysis population: PK evaluable population included all the ITT participants in Arms B and D 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 CL was not evaluated for rituximab.

Groups in this outcome

Arm B (Phase II Randomization): BR in FL

Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.

Arm D (Phase II Randomization): BR in DLBCL

Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.

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
Arm B (Phase II Randomization): BR in FL	32
Arm D (Phase II Randomization): BR in DLBCL	29

Reported measurements

Bendamustine

Analysis denominator · Participants

Group	Source count
Arm B (Phase II Randomization): BR in FL	32
Arm D (Phase II Randomization): BR in DLBCL	29

Values in L/h · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Arm B (Phase II Randomization): BR in FL	54.4	60.9	Not reported	Not reported	Not reported
Arm D (Phase II Randomization): BR in DLBCL	46.4	93.9	Not reported	Not reported	Not reported

Rituximab

Analysis denominator · Participants

Group	Source count
Arm B (Phase II Randomization): BR in FL	0
Arm D (Phase II Randomization): BR in DLBCL	0

Complete source fields

classes

categories
measurements
group Id
OG000
spread
60.9
value
54.4
group Id
OG001
spread
93.9
value
46.4
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
29
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
32
group Id
OG001
value
29
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
id
OG000
title
Arm B (Phase II Randomization): BR in FL
description
Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
id
OG001
title
Arm D (Phase II Randomization): BR in DLBCL

param Type

GEOMETRIC_MEAN

population Description

PK evaluable population included all the ITT participants in Arms B and D 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 CL was not evaluated for 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 II: CL of Bendamustine and Rituximab in Arms B and D

type

SECONDARY

unit Of Measure

L/h

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Preserved source evidence · Not medical advice