Trial · NCT01287741
A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
NCT01287741, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2017-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA). Trials, record NCT01287741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01287741
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
- NCT number
- NCT01287741
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,418 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- Rituximab, Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- First posted
- 2011-02-01
- Last updated
- 2019-04-12
- Results first posted
- 2017-08-17
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Time to Progression-Free Survival (PFS), Investigator-Assessed | Baseline up to approximately 6.5 years (up to 31 January 2018) | Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). |
| Secondary | Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) | Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease \[PD\]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 cm or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants. |
| Secondary | Median Time to Overall Survival (OS) | Baseline up to approximately 6.5 years (up to 31 January 2018) | Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. |
| Secondary | Overall Response Rate (ORR), Investigator-Assessed | Baseline up to approximately 6.5 years (up to 31 January 2018) | Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. |
| Secondary | Overall Response Rate (ORR), IRC-Assessed | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) | Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants. |
| Secondary | Complete Response (CR) at the End of Treatment, Investigator-Assessed | Baseline up to approximately 6.5 years (up to 31 January 2018) | Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. |
| Secondary | Complete Response (CR) at the End of Treatment, IRC-Assessed | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) | Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants. |
| Secondary | Median Time to Event-Free Survival (EFS), Investigator-Assessed | Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018) | Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI. |
| Secondary | Median Time to Disease-Free Survival (DFS), Investigator-Assessed | Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) | Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. |
| Secondary | Duration of Response (DOR), Investigator-Assessed | Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) | DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: \>/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression \>/= 50%. Progression/relapse: at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 cm or \>/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Time to Progression-Free Survival (PFS), Investigator-Assessed | Baseline up to approximately 6.5 years (up to 31 January 2018) | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | months | MEDIAN |
| SECONDARY | Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) | The intent-to-treat (ITT) population included all randomized participants. | months | MEDIAN |
| SECONDARY | Median Time to Overall Survival (OS) | Baseline up to approximately 6.5 years (up to 31 January 2018) | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR), Investigator-Assessed | Baseline up to approximately 6.5 years (up to 31 January 2018) | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR), IRC-Assessed | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) | The intent-to-treat (ITT) population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Complete Response (CR) at the End of Treatment, Investigator-Assessed | Baseline up to approximately 6.5 years (up to 31 January 2018) | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | percentage of participants | NUMBER |
| SECONDARY | Complete Response (CR) at the End of Treatment, IRC-Assessed | Baseline up to approximately 4 years and 9 months (up to 29 April 2016) | The intent-to-treat (ITT) population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Median Time to Event-Free Survival (EFS), Investigator-Assessed | Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018) | The intent-to-treat (ITT) population included all randomized participants, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | months | MEAN |
| SECONDARY | Median Time to Disease-Free Survival (DFS), Investigator-Assessed | Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) | The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR), Investigator-Assessed | Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) | The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis, however because of serious Good Clinical Practice non-compliance at a single study site in China, all 4 participants enrolled at the site (2 in each treatment arm) were excluded from the final analysis. | months | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Time to Progression-Free Survival (PFS), Investigator-Assessed | Rituximab+Chemotherapy | 74.5 | 95% Confidence Interval NA to NA | months | |
| Median Time to Progression-Free Survival (PFS), Investigator-Assessed | Obinutuzumab+Chemotherapy | 68.3 | 95% Confidence Interval 68.3 to NA | months | |
| Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed | Rituximab+Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed | Obinutuzumab+Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Median Time to Overall Survival (OS) | Rituximab+Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Median Time to Overall Survival (OS) | Obinutuzumab+Chemotherapy | NA | 95% Confidence Interval NA to NA | months | |
| Overall Response Rate (ORR), Investigator-Assessed | Rituximab+Chemotherapy | Without PET | 80.1 | percentage of participants | |
| Overall Response Rate (ORR), Investigator-Assessed | Obinutuzumab+Chemotherapy | Without PET | 81.4 | percentage of participants | |
| Overall Response Rate (ORR), Investigator-Assessed | Rituximab+Chemotherapy | With PET | 77.6 | percentage of participants | |
| Overall Response Rate (ORR), Investigator-Assessed | Obinutuzumab+Chemotherapy | With PET | 77.1 | percentage of participants |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab+Chemotherapy | 712 | |
| Overall Study | STARTED | Obinutuzumab+Chemotherapy | 706 | |
| Overall Study | COMPLETED | Rituximab+Chemotherapy | 86 | |
| Overall Study | COMPLETED | Obinutuzumab+Chemotherapy | 91 | |
| Overall Study | NOT COMPLETED | Rituximab+Chemotherapy | 626 | |
| Overall Study | NOT COMPLETED | Obinutuzumab+Chemotherapy | 615 |
Source ClinicalTrials.gov
Adverse events728
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 | Rituximab+Chemotherapy | 101 | 701 | |
| other | Anaemia | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 96 | 702 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Rituximab+Chemotherapy | 44 | 701 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 52 | 702 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab+Chemotherapy | 90 | 701 | |
| other | Leukopenia | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 117 | 702 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab+Chemotherapy | 269 | 701 | |
| other | Neutropenia | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 315 | 702 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab+Chemotherapy | 16 | 701 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Obinutuzumab+Chemotherapy | 58 | 702 |
1 to 10 of 728Source ClinicalTrials.gov
See all 728 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab+Chemotherapy | ||
| Total, all-cause mortality | Obinutuzumab+Chemotherapy | ||
| Total, other adverse events | Rituximab+Chemotherapy | 613 | 701 |
| Total, other adverse events | Obinutuzumab+Chemotherapy | 646 | 702 |
| Total, serious adverse events | Rituximab+Chemotherapy | 269 | 701 |
| Total, serious adverse events | Obinutuzumab+Chemotherapy | 312 | 702 |
Source ClinicalTrials.gov
Papers15
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rituximab+Chemotherapy vs Obinutuzumab+Chemotherapy: serious adverse events |
Source 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.
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