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
CompletedPhase 3Results postedLast updated 22 December 2025
What this trial tests
Phase 3 trial testing Polatuzumab Vedotin in Diffuse Large B-Cell Lymphoma in 270 participants. Completed in 29 November 2024.
18 and older, any sex, with Diffuse Large B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Stage 1: Number of Participants With Adverse Events (AEs)Primary· 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.
Group
Value
95% CI
Stage 1: Pola-R-GemOx
14
Stage 1: Number of Participants With Peripheral Neuropathy (PN)Primary· 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 bur
Group
Value
95% CI
Stage 1: Pola-R-GemOx
8
Stage 2: Overall Survival (OS)Primary· 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.
Group
Value
95% CI
Stage 2: R-GemOx
12.5
8.9 – 15.8
Stage 2: Pola-R-GemOx
19.5
13.3 – NA
Stage 1 and Stage 2: Progression-free Survival (PFS)Secondary· 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. N
Group
Value
95% CI
Stage 1: Pola-R-GemOx
3.9
3.0 – 6.3
Stage 2: R-GemOx
2.7
2.4 – 3.3
Stage 2: Pola-R-GemOx
7.4
6.2 – 11.7
Stage 2: Complete Response Rate (CRR), as Determined by an Independent Review Committee (IRC) at the End of TreatmentSecondary· 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 col
Group
Value
95% CI
Stage 2: R-GemOx
19.0
12.60 – 27.00
Stage 2: Pola-R-GemOx
40.3
31.77 – 49.30
Stage 2: Objective Response Rate (ORR) as Determined by an IRC at End of TreatmentSecondary· 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 evid
Group
Value
95% CI
Stage 2: R-GemOx
24.6
17.37 – 33.07
Stage 2: Pola-R-GemOx
52.7
43.74 – 61.56
Stage 1 and Stage 2: Percentage of Participants With Best Overall Response (BOR) as Determined by the InvestigatorSecondary· 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 indetermin
Group
Value
95% CI
Stage 1: Pola-R-GemOx
46.7
21.27 – 73.41
Stage 2: R-GemOx
34.9
26.65 – 43.92
Stage 2: Pola-R-GemOx
65.1
56.23 – 73.29
Stage 1 and Stage 2: CRR as Determined by the Investigator at End of TreatmentSecondary· 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),
Group
Value
95% CI
Stage 1: Pola-R-GemOx
20.0
4.33 – 48.09
Stage 2: R-GemOx
18.3
11.94 – 26.12
Stage 2: Pola-R-GemOx
35.7
27.42 – 44.57
Stage 1 and Stage 2: ORR as Determined by the Investigator at End of TreatmentSecondary· 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
Group
Value
95% CI
Stage 1: Pola-R-GemOx
26.7
7.79 – 55.10
Stage 2: R-GemOx
24.6
17.37 – 33.07
Stage 2: Pola-R-GemOx
45.0
36.20 – 53.96
Stage 2: Duration of Response (DOR)Secondary· 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.
Group
Value
95% CI
Stage 2: R-GemOx
8.5
3.7 – 26.9
Stage 2: Pola-R-GemOx
11.8
8.6 – 15.5
Stage 1 and Stage 2: Event-free Survival (EFSeff)Secondary· Up to approximately 34 months
EFSeff was defined as the time from randomization to first to the earliest occurrence of the following: PD or relapse using Lugano response criteria (based on either response: including PET-CT data or not including any PET data); death due to any cause or initiation of any NALT. PD based on PET-CT data was defined as score 4 or 5 on 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
Group
Value
95% CI
Stage 1: Pola-R-GemOx
3.9
3.2 – 6.3
Stage 2: R-GemOx
2.7
2.5 – 3.3
Stage 2: Pola-R-GemOx
6.8
5.9 – 9.3
Stage 2: Time to Deterioration in Physical Functioning as Measured by the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, Core 30 (EORTC QLQ-C30)Secondary· Up to approximately 34 months
Time to deterioration was defined as the time from randomization to the first documentation of a 10-point decrease in EORTC QLQ-C30 physical functioning scale. EORTC QLQ-C30 consists of 30 questions assessing five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health status and quality of life (GHS/QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The functioning items were scored on a 4-point scale that ranged from "not at a
Group
Value
95% CI
Stage 2: R-GemOx
2.8
1.4 – 3.0
Stage 2: Pola-R-GemOx
8.1
4.2 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs and SAEs: From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (approximately 8.3 months for Stage 1 and 10.6 months for Stage 2). All-cause Mortality: Up to approximately 34 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07415980 — Phase Ib/II Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients
· Phase 1, PHASE2
· not yet recruiting
NCT07397832 — CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL
· Phase 2
· recruiting
NCT07122609 — Pirtobrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin With or Without Polatuzumab Vedotin in Covalent BT
· Phase 2
· not yet recruiting
NCT07034508 — A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IP
· Phase 2
· not yet recruiting
NCT07012980 — Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL
· Phase 2
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 22 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04182204.