NCT02257567 · OUTCOME
Cohort 1b (Phase Ib): 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 up 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 Cohort 1b (Phase Ib) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.
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.
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 |
|---|
Reported measurements
Baseline Prevalence of ADAs to Polatuzumab vedotin
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 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Post-Baseline Incidence of ADAs to Polatuzumab vedotin
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 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline Prevalence of ADAs to Obinutuzumab
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 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Post-Baseline Incidence of ADA to Obinutuzumab
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 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 1b (Phase Ib Safety Run-In): 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
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Baseline Prevalence of ADAs to Polatuzumab vedotin
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Post-Baseline Incidence of ADAs to Polatuzumab vedotin
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- 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
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Post-Baseline Incidence of ADA to Obinutuzumab
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- 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
- 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
- param Type
- NUMBER
- population Description
- Safety population consisted of all ITT participants from Cohort 1b (Phase Ib) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.
- reporting Status
- POSTED
- time Frame
- Baseline up to approximately Month 24
- title
- Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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