NCT02257567 · OUTCOME
Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab
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
- Not reported
- Time frame
- Baseline to approximately Month 24
What was measured
The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.
Analysis population: Safety population consisted of all ITT participants from Arms E and F (Phase II) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.
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 | 20 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 20 |
|---|
Reported measurements
Baseline Prevalence of ADAs to Polatuzumab
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 19 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 18 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Post-Baseline Incidence of ADAs to Polatuzumab
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 19 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 18 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 5.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 5.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline Prevalence of ADAs to Obinutuzumab
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 20 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 20 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Post-Baseline Incidence of ADAs to Obinutuzumab
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 19 |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 18 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- Baseline Prevalence of ADAs to Polatuzumab
- categories
- measurements
- group Id
- OG000
- value
- 5.3
- group Id
- OG001
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- Post-Baseline Incidence of ADAs to Polatuzumab
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 20
- units
- Participants
- title
- Baseline Prevalence of ADAs to Obinutuzumab
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- Post-Baseline Incidence of ADAs to Obinutuzumab
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.
- 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
- NUMBER
- population Description
- Safety population consisted of all ITT participants from Arms E and F (Phase II) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline to approximately Month 24
- title
- Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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