NCT02257567 · OUTCOME

Phase II: Cmax 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: MEAN
Unit: ug/mL
Interval / dispersion: Standard Deviation
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.

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	38
Arm D (Phase II Randomization): BR in DLBCL	33

Reported measurements

Bendamustine

Analysis denominator · Participants

Group	Source count
Arm B (Phase II Randomization): BR in FL	34
Arm D (Phase II Randomization): BR in DLBCL	30

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm B (Phase II Randomization): BR in FL	3.21	2.09	Not reported	Not reported	Not reported
Arm D (Phase II Randomization): BR in DLBCL	3.85	2.91	Not reported	Not reported	Not reported

Rituximab

Analysis denominator · Participants

Group	Source count
Arm B (Phase II Randomization): BR in FL	38
Arm D (Phase II Randomization): BR in DLBCL	33

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm B (Phase II Randomization): BR in FL	207	50.1	Not reported	Not reported	Not reported
Arm D (Phase II Randomization): BR in DLBCL	183	33.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2.09
value
3.21
group Id
OG001
spread
2.91
value
3.85
denoms
counts
group Id
OG000
value
34
group Id
OG001
value
30
units
Participants
title
Bendamustine
categories
measurements
group Id
OG000
spread
50.1
value
207
group Id
OG001
spread
33.6
value
183
denoms
counts
group Id
OG000
value
38
group Id
OG001
value
33
units
Participants
title
Rituximab

denoms

counts
group Id
OG000
value
38
group Id
OG001
value
33
units
Participants

dispersion Type

Standard Deviation

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

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.

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: Cmax of Bendamustine and Rituximab in Arms B and D

type

SECONDARY

unit Of Measure

ug/mL

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Preserved source evidence · Not medical advice