NCT02257567 · OUTCOME
Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F
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; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
What was measured
PK of three pola-related analytes: acMMAE, unconjugated MMAE and total antibody were measured.
Analysis population: PK evaluable population included all the ITT participants in Arms E and F 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 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 |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 18 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 19 |
|---|
Reported measurements
acMMAE: Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 18 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 19 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 692 | 230 | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 703 | 211 | Not reported | Not reported | Not reported |
|---|
acMMAE: Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 17 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 12 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 845 | 165 | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 713 | 70.6 | Not reported | Not reported | Not reported |
|---|
Total Ab: Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 18 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 19 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 33.3 | 8.04 | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 39.0 | 7.63 | Not reported | Not reported | Not reported |
|---|
Total Ab: Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 17 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 12 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 56.1 | 11.2 | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 37.8 | 4.51 | Not reported | Not reported | Not reported |
|---|
Unconjugated MMAE: Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 |
|---|
Unconjugated MMAE: Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 |
|---|
Bendamustine: Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 16 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 19 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 3.30 | 1.58 | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 5.47 | 4.30 | Not reported | Not reported | Not reported |
|---|
Bendamustine: Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 |
|---|
Obinutuzumab: Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 14 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 13 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 349 | 72.8 | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 274 | 118 | Not reported | Not reported | Not reported |
|---|
Obinutuzumab: Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 16 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 12 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 727 | 217 | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 666 | 190 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 230
- value
- 692
- group Id
- OG001
- spread
- 211
- value
- 703
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- acMMAE: Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 165
- value
- 845
- group Id
- OG001
- spread
- 70.6
- value
- 713
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- acMMAE: Cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 8.04
- value
- 33.3
- group Id
- OG001
- spread
- 7.63
- value
- 39.0
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- Total Ab: Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 11.2
- value
- 56.1
- group Id
- OG001
- spread
- 4.51
- value
- 37.8
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- Total Ab: Cycle 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Unconjugated MMAE: Cycle 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Unconjugated MMAE: Cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 1.58
- value
- 3.30
- group Id
- OG001
- spread
- 4.30
- value
- 5.47
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- Bendamustine: Cycle 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Bendamustine: Cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 72.8
- value
- 349
- group Id
- OG001
- spread
- 118
- value
- 274
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Obinutuzumab: Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 217
- value
- 727
- group Id
- OG001
- spread
- 190
- value
- 666
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- Obinutuzumab: Cycle 4
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 19
- units
- Participants
- description
- PK of three pola-related analytes: acMMAE, unconjugated MMAE and total antibody were measured.
- dispersion Type
- Standard Deviation
- 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
- 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
- OG001
- title
- Arm F (Phase II Expansion): Pola+BG in DLBCL
- param Type
- MEAN
- population Description
- PK evaluable population included all the ITT participants in Arms E and F 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; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
- title
- Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F
- type
- SECONDARY
- unit Of Measure
- ug/mL
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