Trial · NCT04182204
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT04182204, Phase 3, Completed, Hoffmann-La Roche; results first posted 2025-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Trials, record NCT04182204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04182204
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- NCT number
- NCT04182204
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 270 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- Polatuzumab Vedotin, Rituximab, Gemcitabine, Oxaliplatin
- First posted
- 2019-12-02
- Last updated
- 2025-12-22
- Other registries' IDs
- eudract:2018-003727-10
- Results first posted
- 2025-12-22
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1: Number of Participants With Adverse Events (AEs) | From treatment initiation until 90 days after the last dose of study drug or initiation of non-protocol-specified anti-lymphoma treatment (NALT) (Up to approximately 8.3 months) | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Primary | Stage 1: Number of Participants With Peripheral Neuropathy (PN) | From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (Up to approximately 8.3 months) | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants receiving polatuzumab vedotin may develop PN, including peripheral sensory and/or motor neuropathy. Symptoms included hypoesthesia, hyperesthesia, paresthesia, dysesthesia, discomfort, a burning sensation, weakness, gait disturbance, loss of balance, orthostatic hypotension, syncope, or neuropathic pain. |
| Primary | Stage 2: Overall Survival (OS) | From randomization to death (Up to approximately 34 months) | OS was defined as the time from randomization to the death from any cause during the study. Participants who were not reported as having died at the time of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization. Kaplan-Meier (KM) method was used to estimate median OS for each treatment arm. |
| Secondary | Stage 1 and Stage 2: Progression-free Survival (PFS) | From randomization to first occurrence of PD or death (Up to approximately 34 months) | PFS=time from randomization to the first occurrence of disease progression (PD) (based on either: PET-CT data/not including any PET data), as determined by investigator, per Lugano response criteria or death due to any cause, whichever occurs first. PD based on PET-CT data=score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver \&/or new lesions) on 5-point scale (5PS) with an increase in intensity of uptake from baseline at individual target nodes/nodal masses and/or new FDG-avid foci extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment. New lesions: New FDG-avid foci consistent with lymphoma rather than another etiology, Bone marrow: New/recurrent FDG-avid foci. Participants who did not report PD nor died at time of analysis were censored on the date of last evaluable tumor assessment if post-baseline tumor assessment or on date of randomization if no post-baseline tumor assessment. KM methodology was used to estimate median PFS. |
| Secondary | Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of Treatment | Up to approximately 8.5 months | CRR was defined as the percentage of participants who had a complete metabolic response (CMR) based on positron emission tomography-computed tomography (PET-CT) according to Lugano response criteria at the end of treatment as determined by IRC. CMR was defined as score 1, 2, or 3 (1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \>mediastinum but ≤ liver) with or without a residual mass on 5PS at lymph nodes and extra lymphatic sites. In Waldeyer's ring or extranodal sites with high physiologic uptake or with activation within spleen or marrow (e.g., with chemotherapy/myeloid colony-stimulating factors), uptake may be greater than normal mediastinum and/or liver. In this circumstance, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Percentages are rounded off. |
| Secondary | Stage 2: Objective Response Rate (ORR) as Determined by an IRC at End of Treatment | Up to approximately 8.5 months | ORR=percentage of participants with CMR/partial metabolic responses (PMR), based on PET-CT per Lugano response criteria as per an IRC. CMR=score 1, 2, or 3 with/ without a residual mass on 5PS at lymph nodes (LN) \& extra lymphatic sites. In Waldeyer's ring or extra nodal sites with high physiologic uptake or with activation within spleen/marrow, uptake may be greater than normal mediastinum \&/or liver. In this case, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions \& no evidence of FDG-avid disease in bone marrow. PMR=score 4 or 5 on 5PS (4=uptake moderately \> liver; 5=uptake markedly higher than liver \&/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size at LN \& extra lymphatic sites; no new lesions \& residual uptake higher than uptake in normal marrow but reduced compared with baseline. Percentages are rounded off. |
| Secondary | Stage 1 and Stage 2: Percentage of Participants With Best Overall Response (BOR) as Determined by the Investigator | Up to approximately 34 months | BOR was defined as the best response while on study (based on PET-CT or CT data) according to Lugano response criteria, as determined by the investigator. CMR and PMR based on PET-CT data were defined as outlined in the ORR outcome measure (OM) number 8. CT-based complete radiologic response was defined as target lymphatic nodes/nodal masses regression to ≤ 1.5 centimeters (cm) in longest transverse diameter of a lesion (LDi); no extralymphatic sites of disease; absence of non-measured lesion; enlarged organs regress to normal; no new lesions and bone marrow normal by morphology, if indeterminate, immunohistochemistry (IHC) negative. CT-based partial response was defined as ≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extra nodal sites; absent/normal, regressed, but no increase in non-measured lesions; spleen regressed by \>50% in length beyond normal and no new lesions. Percentages are rounded off. |
| Secondary | Stage 1 and Stage 2: CRR as Determined by the Investigator at End of Treatment | Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months | CRR was defined as the percentage of participants who had CMR based positron emission tomography-computed tomography (PET-CT) according to Lugano response criteria at the end of treatment as determined by investigator. CMR was defined as score 1, 2, or 3 (1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \>mediastinum but ≤ liver) with or without a residual mass on 5PS at lymph nodes and extra lymphatic sites. In Waldeyer's ring or extranodal sites with high physiologic uptake or with activation within spleen or marrow (e.g., with chemotherapy/myeloid colony-stimulating factors), uptake may be greater than normal mediastinum and/or liver. In this circumstance, CMR was inferred if uptake at sites of initial involvement is no greater than surrounding normal tissue even if the tissue has high physiologic uptake; no new lesions and no evidence of FDG-avid disease in bone marrow. Percentages are rounded off. |
| Secondary | Stage 1 and Stage 2: ORR as Determined by the Investigator at End of Treatment | Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months | ORR=percentage of participants with CMR/PMR, based on PET-CT as determined by investigator per Lugano response criteria. CMR=score 1, 2, or 3 with/ without a residual mass on 5PS at LN \& extra lymphatic sites. In Waldeyer's ring or extra nodal sites with high physiologic uptake or with activation within spleen/marrow, uptake may be greater than normal mediastinum \&/or liver. In this case, CMR was inferred if uptake at sites of initial involvement was no greater than surrounding normal tissue even if the tissue had high physiologic uptake; no new lesions \& no evidence of FDG-avid disease in bone marrow. PMR=score 4 or 5 on 5PS (4=uptake moderately \> liver; 5=uptake markedly higher than liver \&/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size at LN \& extra lymphatic sites; no new lesions \& residual uptake higher than uptake in normal marrow but reduced compared with baseline. Percentages are rounded off. |
| Secondary | Stage 2: Duration of Response (DOR) | Up to approximately 34 months | DOR=time from the date of the first occurrence of a documented objective response (complete or partial response \[CR/PR\]) (based on PET-CT or CT data) as determined by the investigator, using Lugano response criteria, until PD (based on either response: including PET-CT data or not including any PET data) or death, whichever occurred first. CMR and PMR based on PET-CT data were defined as outlined in the ORR OM. CT-based complete and partial response were defined as outlined in the BOR OM. PD defined as outlined in the PFS OM. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stage 1: Number of Participants With Adverse Events (AEs) | From treatment initiation until 90 days after the last dose of study drug or initiation of non-protocol-specified anti-lymphoma treatment (NALT) (Up to approximately 8.3 months) | Safety run-in population included all participants who received any amount of any study drug during safety run-in stage. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Stage 1: Number of Participants With Peripheral Neuropathy (PN) | From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (Up to approximately 8.3 months) | Safety run-in population included all participants who received any amount of any study drug during safety run-in stage. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Stage 2: Overall Survival (OS) | From randomization to death (Up to approximately 34 months) | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Stage 1 and Stage 2: Progression-free Survival (PFS) | From randomization to first occurrence of PD or death (Up to approximately 34 months) | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | months | MEDIAN |
| SECONDARY | Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of Treatment | Up to approximately 8.5 months | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Stage 2: Objective Response Rate (ORR) as Determined by an IRC at End of Treatment | Up to approximately 8.5 months | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Stage 1 and Stage 2: Percentage of Participants With Best Overall Response (BOR) as Determined by the Investigator | Up to approximately 34 months | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | percentage of participants | NUMBER |
| SECONDARY | Stage 1 and Stage 2: CRR as Determined by the Investigator at End of Treatment | Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | percentage of participants | NUMBER |
| SECONDARY | Stage 1 and Stage 2: ORR as Determined by the Investigator at End of Treatment | Stage 1: Up to approximately 6.2 months and Stage 2: Up to approximately 8.5 months | Safety run-in population included all participants who received any amount of any study drug during stage 1. ITT population included all randomized participants in stage 2. | percentage of participants | NUMBER |
| SECONDARY | Stage 2: Duration of Response (DOR) | Up to approximately 34 months | DOR-evaluable population included all participants who had an objective response (CR or PR). | months | MEDIAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stage 1: Number of Participants With Adverse Events (AEs) | Stage 1: Pola-R-GemOx | 14 | Participants | ||
| Stage 1: Number of Participants With Peripheral Neuropathy (PN) | Stage 1: Pola-R-GemOx | 8 | Participants | ||
| Stage 2: Overall Survival (OS) | Stage 2: R-GemOx | 12.5 | 95% Confidence Interval 8.9 to 15.8 | months | |
| Stage 2: Overall Survival (OS) | Stage 2: Pola-R-GemOx | 19.5 | 95% Confidence Interval 13.3 to NA | months | |
| Stage 1 and Stage 2: Progression-free Survival (PFS) | Stage 1: Pola-R-GemOx | 3.9 | 95% Confidence Interval 3.0 to 6.3 | months | |
| Stage 1 and Stage 2: Progression-free Survival (PFS) | Stage 2: R-GemOx | 2.7 | 95% Confidence Interval 2.4 to 3.3 | months | |
| Stage 1 and Stage 2: Progression-free Survival (PFS) | Stage 2: Pola-R-GemOx | 7.4 | 95% Confidence Interval 6.2 to 11.7 | months | |
| Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of Treatment | Stage 2: R-GemOx | 19.0 | 95% Confidence Interval 12.60 to 27.00 | percentage of participants | |
| Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of Treatment | Stage 2: Pola-R-GemOx | 40.3 | 95% Confidence Interval 31.77 to 49.30 | percentage of participants | |
| Stage 2: Objective Response Rate (ORR) as Determined by an IRC at End of Treatment | Stage 2: R-GemOx | 24.6 | 95% Confidence Interval 17.37 to 33.07 | percentage of participants |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Safety Run-in | STARTED | Stage 1: Pola-R-GemOx | 15 | |
| Safety Run-in | STARTED | Stage 2: R-GemOx | 0 | |
| Safety Run-in | STARTED | Stage 2: Pola-R-GemOx | 0 | |
| Safety Run-in | COMPLETED | Stage 1: Pola-R-GemOx | 5 | |
| Safety Run-in | COMPLETED | Stage 2: R-GemOx | 0 | |
| Safety Run-in | COMPLETED | Stage 2: Pola-R-GemOx | 0 | |
| Safety Run-in | NOT COMPLETED | Stage 1: Pola-R-GemOx | 10 | |
| Safety Run-in | NOT COMPLETED | Stage 2: R-GemOx | 0 | |
| Safety Run-in | NOT COMPLETED | Stage 2: Pola-R-GemOx | 0 | |
| Randomized Controlled Trial | STARTED | Stage 1: Pola-R-GemOx | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events620
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 | Stage 1: Pola-R-GemOx | 2 | 15 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 2: R-GemOx | 32 | 125 | 54 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 2: Pola-R-GemOx | 48 | 128 | 101 |
| other | Anaemia | Blood and lymphatic system disorders | Pola-R-GemOx - Pooled | 50 | 143 | 103 |
| other | Leukocytosis | Blood and lymphatic system disorders | Stage 1: Pola-R-GemOx | 1 | 15 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Stage 2: R-GemOx | 4 | 125 | 5 |
| other | Leukocytosis | Blood and lymphatic system disorders | Stage 2: Pola-R-GemOx | 2 | 128 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Pola-R-GemOx - Pooled | 3 | 143 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Stage 1: Pola-R-GemOx | 0 | 15 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Stage 2: R-GemOx | 10 | 125 | 14 |
1 to 10 of 620Source ClinicalTrials.gov
See all 620 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: Pola-R-GemOx | 9 | 15 |
| Total, all-cause mortality | Stage 2: R-GemOx | 83 | 125 |
| Total, all-cause mortality | Stage 2: Pola-R-GemOx | 68 | 128 |
| Total, all-cause mortality | Pola-R-GemOx - Pooled | 77 | 143 |
| Total, other adverse events | Stage 1: Pola-R-GemOx | 14 | 15 |
| Total, other adverse events | Stage 2: R-GemOx | 111 | 125 |
| Total, other adverse events | Stage 2: Pola-R-GemOx | 119 | 128 |
| Total, other adverse events | Pola-R-GemOx - Pooled | 133 | 143 |
| Total, serious adverse events | Stage 1: Pola-R-GemOx | 2 | 15 |
| Total, serious adverse events | Stage 2: R-GemOx | 39 | 125 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42407012 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Stage 2: R-GemOx vs Stage 2: Pola-R-GemOx: Stage 2: Number of Participants With PN | Trial comparisons |
| Stage 1: Pola-R-GemOx vs Stage 2: Pola-R-GemOx: Stage 1 and Stage 2: Number of Participants With Dose Modification for Polatuzumab Vedotin | Trial comparisons |
| Stage 2: R-GemOx vs Stage 2: Pola-R-GemOx: Stage 2: Number of Participants With AEs | 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04182204
GET https://conductscience.org/api/trials/v1/NCT04182204/registered?page=2