Trial · NCT05171647
A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
NCT05171647, Phase 3, Active not recruiting, Hoffmann-La Roche; results first posted 2026-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma. Trials, record NCT05171647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05171647
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
- NCT number
- NCT05171647
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 208 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Hodgkin Lymphoma
- Interventions
- Mosunetuzumab, Polatuzumab vedotin, Tocilizumab, Rituximab, Gemcitabine, Oxaliplatin
- First posted
- 2021-12-29
- Last updated
- 2026-11-03
- Results first posted
- 2026-03-06
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP) | Up to approximately 23.8 months | ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off. |
| Primary | Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to 32 months | PFS was defined as the time from randomization to first occurrence of disease progression (PD) or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria. |
| Secondary | ORR as Determined by the IRF, According to LRC Using PET-CT or CT Scans in ITT Population | Up to 32 months | ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off. |
| Secondary | ORR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans in ITT Population | Up to approximately 58 months | ORR was defined as the percentage of participants with CR or PR, as determined by the investigator, per Lugano Response Criteria. |
| Secondary | Duration of Response (DoR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to 32 months | DoR was defined as the time from first occurrence of documented PET-CT and/or CT-based objective response (OR) (CR/PR) to PD, or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria. |
| Secondary | DoR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | DoR=time from first occurrence of documented PET-CT and/or CT-based objective response (OR) (CR/PR) to PD, or death from any cause, whichever occurred first, per investigator, per Lugano Response Criteria. |
| Secondary | Overall Survival (OS) | Up to 32 months | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. |
| Secondary | PFS as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | PFS was defined as the time from randomization to first occurrence of PD or death from any cause, whichever occurred first, as determined by the investigator, per Lugano Response Criteria. |
| Secondary | Complete Response Rate (CRR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | CRR was defined as the percentage of participants in whom CR was observed at any time during the study, based on PET-CT and/or CT scans, as determined by the IRF, per Lugano Response Criteria. |
| Secondary | CRR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | CRR was defined as the percentage of participants in whom CR was observed at any time during the study, based on PET-CT and/or CT scans, as determined by the investigator, per Lugano Response Criteria. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | ORR as Determined by the IRF, According to LRC Using PET-CT or CT Scans in ITT Population | Up to 32 months | |||
| SECONDARY | ORR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans in ITT Population | Up to approximately 58 months | |||
| SECONDARY | Duration of Response (DoR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to 32 months | |||
| SECONDARY | DoR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | |||
| SECONDARY | Overall Survival (OS) | Up to 32 months | |||
| SECONDARY | PFS as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | |||
| PRIMARY | Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP) | Up to approximately 23.8 months | IAP population included the first 178 randomized participants, with participants grouped according to their assigned treatment. | percentage of participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to 32 months | Intent-to-treat (ITT) population included all randomized participants, with participants grouped according to their assigned treatment. | months | MEDIAN |
| SECONDARY | Complete Response Rate (CRR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months | |||
| SECONDARY | CRR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans | Up to approximately 58 months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP) | Arm A: Mosun-Pola | 69.7 | 95% Confidence Interval 60.65 to 77.83 | percentage of participants | |
Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP) | Arm B: R-GemOx | 44.1 | 95% Confidence Interval 31.16 to 57.60 | percentage of participants | |
| Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Arm A: Mosun-Pola | 11.5 | 95% Confidence Interval 5.6 to 17.6 | months | |
| Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans | Arm B: R-GemOx | 3.8 | 95% Confidence Interval 2.9 to 4.1 | months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Mosun-Pola | 138 | |
| Overall Study | STARTED | Arm B: R-GemOx | 70 | |
| Overall Study | Safety-evaluable (SE) Population | Arm A: Mosun-Pola | 135 | |
| Overall Study | Safety-evaluable (SE) Population | Arm B: R-GemOx | 64 | |
| Overall Study | COMPLETED | Arm A: Mosun-Pola | 0 | |
| Overall Study | COMPLETED | Arm B: R-GemOx | 0 | |
| Overall Study | NOT COMPLETED | Arm A: Mosun-Pola | 138 | |
| Overall Study | NOT COMPLETED | Arm B: R-GemOx | 70 |
Source ClinicalTrials.gov
Adverse events224
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 | Arm A: Mosun-Pola | 41 | 135 | 50 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: R-GemOx | 27 | 64 | 33 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Mosun-Pola | 9 | 135 | 13 |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: R-GemOx | 2 | 64 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm A: Mosun-Pola | 11 | 135 | 17 |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm B: R-GemOx | 5 | 64 | 8 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Mosun-Pola | 44 | 135 | 78 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: R-GemOx | 18 | 64 | 28 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Mosun-Pola | 5 | 135 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: R-GemOx | 22 | 64 | 28 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Mosun-Pola | 66 | 135 |
| Total, all-cause mortality | Arm B: R-GemOx | 35 | 64 |
| Total, other adverse events | Arm A: Mosun-Pola | 129 | 135 |
| Total, other adverse events | Arm B: R-GemOx | 60 | 64 |
| Total, serious adverse events | Arm A: Mosun-Pola | 45 | 135 |
| Total, serious adverse events | Arm B: R-GemOx | 16 | 64 |
Source ClinicalTrials.gov
Papers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Mosun-Pola vs Arm B: R-GemOx: deaths from any cause | Trial comparisons |
| Arm A: Mosun-Pola vs Arm B: R-GemOx: 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.
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/NCT05171647
GET https://conductscience.org/api/trials/v1/NCT05171647/events?page=2