NCT02257567 · OUTCOME

DLBCL Cohorts: Percentage of Participants With BOR Based PET-CT or CT Only as Determined by IRC

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: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)

What was measured

BOR=CR/PR per PET-CT/CT per MLRC.CR per PET-CT=complete MR in LN \& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no uptake(UT) above background;2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT markedly higher than liver \&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in LN \& ELS, score=4 or 5, reduced UT than baseline (BL) \& residual mass of any size;residual UT\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.

Analysis population: ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Groups in this outcome

Arm C (Phase II Randomization): 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.

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.

Arm F (Phase II Expansion): 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.

Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

Participants with DLBCL received pola (lyophilized formulation), 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
Arm C (Phase II Randomization): Pola+BR in DLBCL	40
Arm D (Phase II Randomization): BR in DLBCL	40
Arm F (Phase II Expansion): Pola+BG in DLBCL	21
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	106

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm C (Phase II Randomization): Pola+BR in DLBCL	62.5	Not reported	45.80	77.27	Not reported
Arm D (Phase II Randomization): BR in DLBCL	25.0	Not reported	12.69	41.20	Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL	42.9	Not reported	21.82	65.98	Not reported
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL	57.5	Not reported	47.57	67.09	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
15.82
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
54.62
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0005
param Type
Difference in Response Rates
param Value
37.50
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
15.82
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
54.62
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0005
param Type
Difference in Response Rates
param Value
37.50
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
lower Limit
45.80
upper Limit
77.27
value
62.5
group Id
OG001
lower Limit
12.69
upper Limit
41.20
value
25.0
group Id
OG002
lower Limit
21.82
upper Limit
65.98
value
42.9
group Id
OG003
lower Limit
47.57
upper Limit
67.09
value
57.5

denoms

counts
group Id
OG000
value
40
group Id
OG001
value
40
group Id
OG002
value
21
group Id
OG003
value
106
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
OG000
title
Arm C (Phase II Randomization): Pola+BR in DLBCL
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
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
OG002
title
Arm F (Phase II Expansion): Pola+BG in DLBCL
description
Participants with DLBCL received pola (lyophilized formulation), 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
OG003
title
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

param Type

NUMBER

population Description

ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

reporting Status

POSTED

time Frame

Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)

title

DLBCL Cohorts: Percentage of Participants With BOR Based PET-CT or CT Only as Determined by IRC

type

SECONDARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice