Trial · NCT02257567
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
NCT02257567, Phase 1, Phase 2, Completed, Hoffmann-La Roche; results first posted 2022-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02257567. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02257567
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT02257567
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 331 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphoma
- Interventions
- Bendamustine, Obinutuzumab, Polatuzumab vedotin (Liquid), Rituximab, Polatuzumab vedotin (Lyophilized)
- First posted
- 2014-10-06
- Last updated
- 2022-11-14
- Other registries' IDs
- eudract:2014-001361-28
- Results first posted
- 2022-11-14
Source ClinicalTrials.gov
Registered outcomes78
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Percentage of Participants With Adverse Events (AEs) | From the study start up to the end of the study (up to approximately 84 months) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). |
| Primary | Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs | From Month 37 to Month 84 (up to approximately 47 months) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. 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. |
| Primary | Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin | Baseline up to approximately Month 24 | The number of participants with positive results for ADA against pola 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 titer unit (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. |
| Primary | Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab | Baseline up to approximately Month 24 | 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. |
| Primary | Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized) | From Month 37 to Month 84 (up to approximately 47 months) | The number of participants with positive results for ADA against lyophilized pola 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. |
| Primary | Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC) | 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | CR was assessed by IRC at PRA according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS) where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number. |
| Primary | Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC | 6-8 weeks after Cycle 6, Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks) | CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number. |
| Primary | Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks | Pharmacokinetic (PK) of three pola-related analytes: antibody conjugated monomethyl auristatin E (acMMAE), total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is nanograms\*day per milliliters. |
| Primary | Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks | PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. |
| Primary | Arm G (Phase II NF Cohort): Systemic Clearance (CL) of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks | PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. Unit of measure for CL is milliliters per day per kilograms (mL/day/kg) |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 registered outcomesOutcomes78
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase Ib: Percentage of Participants With Adverse Events (AEs) | From the study start up to the end of the study (up to approximately 84 months) | Safety population consisted of all ITT participants from Phase Ib who received at least one dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs | From Month 37 to Month 84 (up to approximately 47 months) | Safety population consisted of all ITT participants from Arms G+H (Phase II NF Cohort) who received at least one dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin | Baseline up to approximately Month 24 | Safety population consisted of all ITT participants from Cohort 1a (Phase Ib) who received at least one dose of study medication. | percentage of participants | NUMBER |
| PRIMARY | Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab | Baseline up to approximately Month 24 | 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. | percentage of participants | NUMBER |
| PRIMARY | Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized) | From Month 37 to Month 84 (up to approximately 47 months) | Safety population consisted of all ITT participants from Arm G+H (Phase II NF cohort) who received at least one dose of study medication. 'Overall Number Analyzed' is 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. | percentage of participants | NUMBER |
| PRIMARY | Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC) | 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks) | ITT population included all randomized participants in Phase II Randomized and NF cohorts irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
| PRIMARY | Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC | 6-8 weeks after Cycle 6, Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks) | ITT population included all randomized participants in Arm H (Phase II NF Cohort) irrespective of whether or not they received the study treatment. | percentage of participants | NUMBER |
| PRIMARY | Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks | PK population included all ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point. | ng*day/mL | GEOMETRIC_MEAN |
| PRIMARY | Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks | PK evaluable population included all the ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point. | nanograms per milliliters (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Arm G (Phase II NF Cohort): Systemic Clearance (CL) of Polatuzumab Vedotin (Lyophilized) | Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks | As pre-specified in the protocol the analysis of this outcome measure (OM) was based on sponsor's discretion however, sponsor opted to not collect data for this OM. |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 outcomesResults by group986
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase Ib: Percentage of Participants With Adverse Events (AEs) | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL | 100 | percentage of participants | ||
| Phase Ib: Percentage of Participants With Adverse Events (AEs) | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL | 100 | percentage of participants | ||
| Phase Ib: Percentage of Participants With Adverse Events (AEs) | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | 100 | percentage of participants | ||
| Phase Ib: Percentage of Participants With Adverse Events (AEs) | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL | 100 | percentage of participants | ||
| Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs | Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 99.1 | percentage of participants | ||
| Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL | Baseline Prevalence of ADAs | 50.0 | percentage of participants | |
| Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL | Baseline Prevalence of ADAs | 33.3 | percentage of participants | |
| Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL | Post-Baseline Incidence of ADAs | 0 | percentage of participants | |
| Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL | Post-Baseline Incidence of ADAs | 33.3 | percentage of participants | |
| Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | Baseline Prevalence of ADAs to Polatuzumab vedotin | 0 | percentage of participants |
1 to 10 of 986Source ClinicalTrials.gov
See all 986 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL | 6 | |
| Overall Study | STARTED | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL | 6 | |
| Overall Study | STARTED | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | 6 | |
| Overall Study | STARTED | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL | 6 | |
| Overall Study | STARTED | Arm A (Phase II Randomization): Pola+BR in FL | 39 | |
| Overall Study | STARTED | Arm B (Phase II Randomization): BR in FL | 41 | |
| Overall Study | STARTED | Arm C (Phase II Randomization): Pola+BR in DLBCL | 40 | |
| Overall Study | STARTED | Arm D (Phase II Randomization): BR in DLBCL | 40 | |
| Overall Study | STARTED | Arm E (Phase II Expansion): Pola+BG in FL | 20 | |
| Overall Study | STARTED | Arm F (Phase II Expansion): Pola+BG in DLBCL | 21 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events4,598
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL | 1 | 6 | 2 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL | 0 | 6 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | 0 | 6 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL | 0 | 6 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Arm A (Phase II Randomization): Pola+BR in FL | 6 | 38 | 24 |
| other | ANAEMIA | Blood and lymphatic system disorders | Arm B (Phase II Randomization): BR in FL | 5 | 41 | 5 |
| other | ANAEMIA | Blood and lymphatic system disorders | Arm C (Phase II Randomization): Pola+BR in DLBCL | 10 | 39 | 13 |
| other | ANAEMIA | Blood and lymphatic system disorders | Arm D (Phase II Randomization): BR in DLBCL | 19 | 39 | 28 |
| other | ANAEMIA | Blood and lymphatic system disorders | Arm E (Phase II Expansion): Pola+BG in FL | 3 | 20 | 7 |
| other | ANAEMIA | Blood and lymphatic system disorders | Arm F (Phase II Expansion): Pola+BG in DLBCL | 5 | 20 | 6 |
1 to 10 of 4,598Source ClinicalTrials.gov
See all 4,598 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL | 2 | 6 |
| Total, all-cause mortality | Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL | 2 | 6 |
| Total, all-cause mortality | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL | 2 | 6 |
| Total, all-cause mortality | Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL | 4 | 6 |
| Total, all-cause mortality | Arm A (Phase II Randomization): Pola+BR in FL | 16 | 39 |
| Total, all-cause mortality | Arm B (Phase II Randomization): BR in FL | 11 | 41 |
| Total, all-cause mortality | Arm C (Phase II Randomization): Pola+BR in DLBCL | 26 | 40 |
| Total, all-cause mortality | Arm D (Phase II Randomization): BR in DLBCL | 30 | 40 |
| Total, all-cause mortality | Arm E (Phase II Expansion): Pola+BG in FL | 3 | 20 |
| Total, all-cause mortality | Arm F (Phase II Expansion): Pola+BG in DLBCL | 18 | 21 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT02257567/registered?page=2