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
g/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycles 1 and 4 Days 1: pre-dose and 30 min post dose; Cycle 2 Day1: pre-dose; Follow up visits on Day 1: Months 3, 6, 12, 18 and 24; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)
What was measured
Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.
Analysis population: PK evaluable population included all the ITT participants who Cohort 1b (Phase 1b) and Arms E and F (Phase II) 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 timepoint.
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.
Arm E (Phase II Expansion): 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.
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.
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
Arm E (Phase II Expansion): Pola+BG in FL
19
Arm F (Phase II Expansion): Pola+BG in DLBCL
19
Reported measurements
Cycle 1 Day 1: Pre-dose
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
5
Arm E (Phase II Expansion): Pola+BG in FL
19
Arm F (Phase II Expansion): Pola+BG in DLBCL
19
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
NA
NA
Not reported
Not reported
The data is not evaluable as the samples were BLLQ.
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
NA
NA
Not reported
Not reported
The data is not evaluable as the samples were BLLQ.
Arm E (Phase II Expansion): Pola+BG in FL
NA
NA
Not reported
Not reported
The data is not evaluable as the samples were BLLQ.
Arm F (Phase II Expansion): Pola+BG in DLBCL
NA
NA
Not reported
Not reported
The data is not evaluable as the samples were BLLQ.
Cycle 1 Day 1: 30 min Post Dose
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
Arm E (Phase II Expansion): Pola+BG in FL
14
Arm F (Phase II Expansion): Pola+BG in DLBCL
13
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Arm E (Phase II Expansion): Pola+BG in FL
341
22.1
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
221
105.5
Not reported
Not reported
Not reported
Cycle 2 Day 1: Pre-dose
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
Arm E (Phase II Expansion): Pola+BG in FL
18
Arm F (Phase II Expansion): Pola+BG in DLBCL
17
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
283
38.4
Not reported
Not reported
Not reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
412
40.8
Not reported
Not reported
Not reported
Arm E (Phase II Expansion): Pola+BG in FL
301
39.3
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
349
58.0
Not reported
Not reported
Not reported
Cycle 4 Day 1: Pre-dose
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
4
Arm E (Phase II Expansion): Pola+BG in FL
17
Arm F (Phase II Expansion): Pola+BG in DLBCL
12
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
293
53.8
Not reported
Not reported
Not reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
359
28.9
Not reported
Not reported
Not reported
Arm E (Phase II Expansion): Pola+BG in FL
291
37.9
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
290
36.4
Not reported
Not reported
Not reported
Cycle 4 Day 1: 30 min Post Dose
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
Arm E (Phase II Expansion): Pola+BG in FL
16
Arm F (Phase II Expansion): Pola+BG in DLBCL
12
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Arm E (Phase II Expansion): Pola+BG in FL
701
27.4
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
642
29.5
Not reported
Not reported
Not reported
Follow up on Month 3, Day 1
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
2
Arm E (Phase II Expansion): Pola+BG in FL
16
Arm F (Phase II Expansion): Pola+BG in DLBCL
8
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
67.7
47.8
Not reported
Not reported
Not reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
28.8
17.0
Not reported
Not reported
Not reported
Arm E (Phase II Expansion): Pola+BG in FL
38.5
167.8
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
55.1
119.9
Not reported
Not reported
Not reported
Follow up on Month 6, Day 1
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
2
Arm E (Phase II Expansion): Pola+BG in FL
10
Arm F (Phase II Expansion): Pola+BG in DLBCL
7
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
11.5
56.6
Not reported
Not reported
Not reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
5.38
12.4
Not reported
Not reported
Not reported
Arm E (Phase II Expansion): Pola+BG in FL
7.64
412.2
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
15.8
137.6
Not reported
Not reported
Not reported
Follow up on Month 12, Day 1
Analysis denominator · Participants
Group
Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
4
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
3
Arm E (Phase II Expansion): Pola+BG in FL
6
Arm F (Phase II Expansion): Pola+BG in DLBCL
2
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
0.237
717.6
Not reported
Not reported
Not reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
0.389
119.3
Not reported
Not reported
Not reported
Arm E (Phase II Expansion): Pola+BG in FL
0.162
569.7
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
0.732
18.7
Not reported
Not reported
Not reported
Follow up on Month 18, Day 1
Analysis denominator · Participants
Group
Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
2
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
2
Arm E (Phase II Expansion): Pola+BG in FL
7
Arm F (Phase II Expansion): Pola+BG in DLBCL
3
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
0.00978
1188.5
Not reported
Not reported
Not reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
0.0107
170.5
Not reported
Not reported
Not reported
Arm E (Phase II Expansion): Pola+BG in FL
0.00842
347.4
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
0.0460
86.9
Not reported
Not reported
Not reported
Follow up on Month 24, Day 1
Analysis denominator · Participants
Group
Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
1
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
1
Arm E (Phase II Expansion): Pola+BG in FL
0
Arm F (Phase II Expansion): Pola+BG in DLBCL
1
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
0.00203
NA
Not reported
Not reported
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
0.00203
NA
Not reported
Not reported
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Arm F (Phase II Expansion): Pola+BG in DLBCL
0.00203
NA
Not reported
Not reported
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Unscheduled
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
1
Arm E (Phase II Expansion): Pola+BG in FL
1
Arm F (Phase II Expansion): Pola+BG in DLBCL
0
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
3.09
NA
Not reported
Not reported
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Arm E (Phase II Expansion): Pola+BG in FL
20.8
NA
Not reported
Not reported
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Unscheduled Visit: Pre-dose
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
Arm E (Phase II Expansion): Pola+BG in FL
0
Arm F (Phase II Expansion): Pola+BG in DLBCL
1
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Arm F (Phase II Expansion): Pola+BG in DLBCL
0.0626
NA
Not reported
Not reported
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Unscheduled Visit: 30 min Post Dose
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
Arm E (Phase II Expansion): Pola+BG in FL
0
Arm F (Phase II Expansion): Pola+BG in DLBCL
1
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Arm F (Phase II Expansion): Pola+BG in DLBCL
349
NA
Not reported
Not reported
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Study Treatment Completion Visit
Analysis denominator · Participants
Group
Source count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
1
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
0
Arm E (Phase II Expansion): Pola+BG in FL
14
Arm F (Phase II Expansion): Pola+BG in DLBCL
8
Values in g/mL · Interval/dispersion: Geometric Coefficient of Variation
Group
Value
Spread
Lower
Upper
Comment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
367
NA
Not reported
Not reported
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Arm E (Phase II Expansion): Pola+BG in FL
242
52.7
Not reported
Not reported
Not reported
Arm F (Phase II Expansion): Pola+BG in DLBCL
232
46.2
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
comment
The data is not evaluable as the samples were BLLQ.
group Id
OG000
spread
NA
value
NA
comment
The data is not evaluable as the samples were BLLQ.
group Id
OG001
spread
NA
value
NA
comment
The data is not evaluable as the samples were BLLQ.
group Id
OG002
spread
NA
value
NA
comment
The data is not evaluable as the samples were BLLQ.
group Id
OG003
spread
NA
value
NA
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
5
group Id
OG002
value
19
group Id
OG003
value
19
units
Participants
title
Cycle 1 Day 1: Pre-dose
categories
measurements
group Id
OG002
spread
22.1
value
341
group Id
OG003
spread
105.5
value
221
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
14
group Id
OG003
value
13
units
Participants
title
Cycle 1 Day 1: 30 min Post Dose
categories
measurements
group Id
OG000
spread
38.4
value
283
group Id
OG001
spread
40.8
value
412
group Id
OG002
spread
39.3
value
301
group Id
OG003
spread
58.0
value
349
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
18
group Id
OG003
value
17
units
Participants
title
Cycle 2 Day 1: Pre-dose
categories
measurements
group Id
OG000
spread
53.8
value
293
group Id
OG001
spread
28.9
value
359
group Id
OG002
spread
37.9
value
291
group Id
OG003
spread
36.4
value
290
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
4
group Id
OG002
value
17
group Id
OG003
value
12
units
Participants
title
Cycle 4 Day 1: Pre-dose
categories
measurements
group Id
OG002
spread
27.4
value
701
group Id
OG003
spread
29.5
value
642
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
16
group Id
OG003
value
12
units
Participants
title
Cycle 4 Day 1: 30 min Post Dose
categories
measurements
group Id
OG000
spread
47.8
value
67.7
group Id
OG001
spread
17.0
value
28.8
group Id
OG002
spread
167.8
value
38.5
group Id
OG003
spread
119.9
value
55.1
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
2
group Id
OG002
value
16
group Id
OG003
value
8
units
Participants
title
Follow up on Month 3, Day 1
categories
measurements
group Id
OG000
spread
56.6
value
11.5
group Id
OG001
spread
12.4
value
5.38
group Id
OG002
spread
412.2
value
7.64
group Id
OG003
spread
137.6
value
15.8
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
2
group Id
OG002
value
10
group Id
OG003
value
7
units
Participants
title
Follow up on Month 6, Day 1
categories
measurements
group Id
OG000
spread
717.6
value
0.237
group Id
OG001
spread
119.3
value
0.389
group Id
OG002
spread
569.7
value
0.162
group Id
OG003
spread
18.7
value
0.732
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
6
group Id
OG003
value
2
units
Participants
title
Follow up on Month 12, Day 1
categories
measurements
group Id
OG000
spread
1188.5
value
0.00978
group Id
OG001
spread
170.5
value
0.0107
group Id
OG002
spread
347.4
value
0.00842
group Id
OG003
spread
86.9
value
0.0460
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
7
group Id
OG003
value
3
units
Participants
title
Follow up on Month 18, Day 1
categories
measurements
comment
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
group Id
OG000
spread
NA
value
0.00203
comment
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
group Id
OG001
spread
NA
value
0.00203
comment
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
group Id
OG003
spread
NA
value
0.00203
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
1
units
Participants
title
Follow up on Month 24, Day 1
categories
measurements
comment
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
group Id
OG001
spread
NA
value
3.09
comment
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
group Id
OG002
spread
NA
value
20.8
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
0
units
Participants
title
Unscheduled
categories
measurements
comment
Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
group Id
OG003
spread
NA
value
0.0626
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
units
Participants
title
Unscheduled Visit: Pre-dose
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
19
group Id
OG003
value
19
units
Participants
description
Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.
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 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
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
OG002
title
Arm E (Phase II Expansion): 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
OG003
title
Arm F (Phase II Expansion): Pola+BG in DLBCL
param Type
GEOMETRIC_MEAN
population Description
PK evaluable population included all the ITT participants who Cohort 1b (Phase 1b) and Arms E and F (Phase II) 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 timepoint.
reporting Status
POSTED
time Frame
Cycles 1 and 4 Days 1: pre-dose and 30 min post dose; Cycle 2 Day1: pre-dose; Follow up visits on Day 1: Months 3, 6, 12, 18 and 24; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)
Triangle