Trial · NCT04236141
A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).
NCT04236141, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2022-08-04
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL). Trials, record NCT04236141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04236141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).
- NCT number
- NCT04236141
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Interventions
- Polatuzumab Vedotin, Bendamustine, Rituximab, Placebo
- First posted
- 2020-01-22
- Last updated
- 2023-03-03
- Results first posted
- 2022-08-04
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC) | Up to approximately 23 weeks | CR was determined by IRC according to the Lugano Response Criteria (LRC) for Malignant Lymphoma. Per LRC , CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites 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 new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. |
| Secondary | Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator | Up to approximately to 23 weeks | CR was determined by investigator according to the LRC for Malignant Lymphoma. Per LRC, CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites 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 new lesions and no evidence of FDG-avid disease in bone marrow. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. Percentages have been rounded off to the first decimal point. |
| Secondary | Percentage of Participants With Objective Response (OR) at EOT Based on PET-CT as Assessed by Investigator | Up to approximately 23 weeks | OR was defined as CR or partial response (PR) at the end of treatment assessment based on PET-CT, as determined by the investigator according to the LRC. CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites 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 new lesions and no evidence of FDG-avid disease in bone marrow. PR based on PET-CT was defined as partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size; no new lesions and residual uptake higher than uptake in normal bone marrow but reduced compared with baseline. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. |
| Secondary | Percentage of Participants With OR at EOT Based on PET-CT as Assessed by IRC | Up to approximately 23 weeks | OR was defined as CR or PR at the end of treatment assessment based on PET-CT, as determined by the IRC according to the LRC. CR based on PET-CT was defined as complete MR in lymph nodes and extralymphatic sites 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 new lesions and no evidence of FDG-avid disease in bone marrow. PR per PET-CT was defined as partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size; no new lesions and residual uptake higher than uptake in normal marrow but reduced compared with baseline. The analysis was done 6-8 weeks after Cycle 6, Day 1(1 cycle= 21 days) or after final dose of study treatment.Percentages have been rounded off to the first decimal point. |
| Secondary | Percentage of Participants With CR at EOT Based on Computed Tomography (CT) as Assessed by Investigator | Up to approximately 23 weeks | CR was determined by the investigator according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. |
| Secondary | Percentage of Participants With CR at EOT Based on CT as Assessed by IRC | Up to approximately 23 weeks | CR was determined by the IRC according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. |
| Secondary | Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by Investigator | Up to approximately 23 weeks | OR was defined as CR or PR, at the EOT assessment based on CT only, as determined by the investigator according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. Per LRC, PR was defined as ≥ 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target nodes and extranodal sites; non-measured lesion is absent/normal, regressed, but no increase; spleen must have regressed by \>50 % in length beyond normal; and no new lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. Percentages have been rounded off to the first decimal point. |
| Secondary | Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by IRC | Up to approximately 23 weeks | OR was defined as percentage of participants with CR or PR, at EOT assessment based on CT only, as determined by IRC according to the LRC. Per LRC, CR based on CT was defined as complete radiologic response with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi. PR is ≥ 50% decrease in SPD of up to 6 target nodes and extranodal sites. The analysis was done 6-8 weeks after Cycle 6, Day 1 (1 cycle = 21 days) or after final dose of study treatment. |
| Secondary | Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by Investigator | Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks) | BOR=CR/PR per PET-CT/CT by investigator per LRC.CR perPET-CT=complete MR in lymph nodes \& extralymphatic sites(ELS),score=1,2,3 with/without residual mass on5PS,1=no uptake(UT)above background;2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT markedly higher than liver and/or new lesions; no new lesions \& FDG-avid disease absent in bone marrow.CR perCT=complete radiologic response with target nodes/nodal masses regressedto≤1.5 cm in LDi\&no ELS of disease;absence of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow morphology=normal,if indeterminate,IHC negative.PR per PET-CT=partial MR in lymph nodes\&ELS,score=4or5,reduced UT than baseline(BL)\&residual masses=any size;no new lesions\&residual UT \>UT in normal marrow,reduced than BL.PR per CT by LCR=≥50% decrease in SPD of up to 6 target nodes \& extranodal sites;non-measured lesion=absent/normal,regressed,no increase;spleen=regressed by\>50%in length beyond normal;no new lesions. |
| Secondary | Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by IRC | Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks) | BOR=CR/PR per PET-CT/CT by IRC per LRC. CR per PET-CT=complete MR in lymph nodes\& ELS, score=1, 2,3 with/without residual mass on 5PS, 1=no UT above background; 2=UT≤mediastinum; 3=UT\>mediastinum but ≤liver; 4=UT moderately\>liver; 5=UT markedly higher than liver and/or new lesions; no new lesions \& FDG-avid disease absent in bone marrow.CR per CT=complete radiologic response with target nodes/nodal masses regressed to≤1.5 cm in LDi and no ELS of disease; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; bone marrow morphology=normal, if indeterminate, IHC negative. PR per PET-CT=partial MR in lymph nodes \& ELS, score =4 or 5,reduced UT than baseline(BL)\&residual masses=any size; no new lesions \&residual UT \>UT in normal marrow, reduced than BL.PR per CT by LCR=≥50% decrease in SPD of up to 6 target nodes\& extranodal sites; non-measured lesion=absent/normal, regressed, no increase; spleen=regressed by\>50% in length beyond normal; no new lesions. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC) | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator | Up to approximately to 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) at EOT Based on PET-CT as Assessed by Investigator | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOT Based on PET-CT as Assessed by IRC | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOT Based on Computed Tomography (CT) as Assessed by Investigator | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOT Based on CT as Assessed by IRC | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by Investigator | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOT Assessment Based on CT as Assessed by IRC | Up to approximately 23 weeks | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by Investigator | Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks) | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) Based on PET-CT or CT Only as Assessed by IRC | Up to every 6 months after end of treatment assessment until disease progression, study withdrawal, end of study, or death, whichever occurred first (up to approximately 82 weeks) | ITT population included all participants randomized, whether or not the participants received the assigned treatment. | percentage of participants | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC) | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 25.0 | 95% Confidence Interval 10.69 to 44.87 | percentage of participants | |
Percentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC) | Placebo Plus Bendamustine and Rituximab | 14.3 | 95% Confidence Interval 1.78 to 42.81 | percentage of participants | |
| Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 21.4 | 95% Confidence Interval 8.30 to 40.95 | percentage of participants | |
| Percentage of Participants With CR at the EOT Assessment Based on PET-CT as Assessed by Investigator | Placebo Plus Bendamustine and Rituximab | 14.3 | 95% Confidence Interval 1.78 to 42.81 | percentage of participants | |
| Percentage of Participants With Objective Response (OR) at EOT Based on PET-CT as Assessed by Investigator | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 28.6 | 95% Confidence Interval 13.22 to 48.67 | percentage of participants | |
| Percentage of Participants With Objective Response (OR) at EOT Based on PET-CT as Assessed by Investigator | Placebo Plus Bendamustine and Rituximab | 14.3 | 95% Confidence Interval 1.78 to 42.81 | percentage of participants | |
| Percentage of Participants With OR at EOT Based on PET-CT as Assessed by IRC | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 35.7 | 95% Confidence Interval 18.64 to 55.93 | percentage of participants | |
| Percentage of Participants With OR at EOT Based on PET-CT as Assessed by IRC | Placebo Plus Bendamustine and Rituximab | 14.3 | 95% Confidence Interval 1.78 to 42.81 | percentage of participants | |
| Percentage of Participants With CR at EOT Based on Computed Tomography (CT) as Assessed by Investigator | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 17.9 | 95% Confidence Interval 6.06 to 36.89 | percentage of participants | |
| Percentage of Participants With CR at EOT Based on Computed Tomography (CT) as Assessed by Investigator | Placebo Plus Bendamustine and Rituximab | 0 | 95% Confidence Interval 0.00 to 23.16 | percentage of participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 28 | |
| Overall Study | STARTED | Placebo Plus Bendamustine and Rituximab | 14 | |
| Overall Study | Safety Population | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 27 | |
| Overall Study | Safety Population | Placebo Plus Bendamustine and Rituximab | 14 | |
| Overall Study | Pharmacokinetic-Evaluable Population | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 27 | |
| Overall Study | Pharmacokinetic-Evaluable Population | Placebo Plus Bendamustine and Rituximab | 0 | |
| Overall Study | Immunogenicity-Evaluable Population (Baseline Evaluable) | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 27 | |
| Overall Study | Immunogenicity-Evaluable Population (Baseline Evaluable) | Placebo Plus Bendamustine and Rituximab | 14 | |
| Overall Study | Immunogenicity-Evaluable Population (Post-Baseline Evaluable) | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 24 | |
| Overall Study | Immunogenicity-Evaluable Population (Post-Baseline Evaluable) | Placebo Plus Bendamustine and Rituximab | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events182
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 | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 16 | 27 | 28 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Plus Bendamustine and Rituximab | 5 | 14 | 7 |
| other | Leukocytosis | Blood and lymphatic system disorders | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 1 | 27 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo Plus Bendamustine and Rituximab | 1 | 14 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 3 | 27 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo Plus Bendamustine and Rituximab | 0 | 14 | 0 |
| other | Myelosuppression | Blood and lymphatic system disorders | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 0 | 27 | 0 |
| other | Myelosuppression | Blood and lymphatic system disorders | Placebo Plus Bendamustine and Rituximab | 1 | 14 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 4 | 27 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo Plus Bendamustine and Rituximab | 3 | 14 | 3 |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 18 | 28 |
| Total, all-cause mortality | Placebo Plus Bendamustine and Rituximab | 10 | 14 |
| Total, other adverse events | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 27 | 27 |
| Total, other adverse events | Placebo Plus Bendamustine and Rituximab | 14 | 14 |
| Total, serious adverse events | Polatuzumab Vedotin Plus Bendamustine and Rituximab | 12 | 27 |
| Total, serious adverse events | Placebo Plus Bendamustine and Rituximab | 3 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Polatuzumab Vedotin Plus Bendamustine and Rituximab vs Placebo Plus Bendamustine and Rituximab: deaths from any cause | Trial comparisons |
| Polatuzumab Vedotin Plus Bendamustine and Rituximab vs Placebo Plus Bendamustine and Rituximab: serious adverse events | Trial comparisons |
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.
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Read this trial from software.
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