A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
TerminatedPhase 3Results postedLast updated 12 April 2019
What this trial tests
Phase 3 trial testing Rituximab in Diffuse Large B-Cell Lymphoma in 1,418 participants. Terminated before completion.
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.
Median Time to Progression-Free Survival (PFS), Investigator-AssessedPrimary· 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 oth
Group
Value
95% CI
Rituximab+Chemotherapy
74.5
NA – NA
Obinutuzumab+Chemotherapy
68.3
68.3 – NA
Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-AssessedSecondary· 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 hep
Group
Value
95% CI
Rituximab+Chemotherapy
NA
NA – NA
Obinutuzumab+Chemotherapy
NA
NA – NA
Median Time to Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Rituximab+Chemotherapy
NA
NA – NA
Obinutuzumab+Chemotherapy
NA
NA – NA
Overall Response Rate (ORR), Investigator-AssessedSecondary· 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.
Without PET
Group
Value
95% CI
Rituximab+Chemotherapy
80.1
Obinutuzumab+Chemotherapy
81.4
With PET
Group
Value
95% CI
Rituximab+Chemotherapy
77.6
Obinutuzumab+Chemotherapy
77.1
Overall Response Rate (ORR), IRC-AssessedSecondary· 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.
Without PET
Group
Value
95% CI
Rituximab+Chemotherapy
80.2
Obinutuzumab+Chemotherapy
82.3
With PET
Group
Value
95% CI
Rituximab+Chemotherapy
81.1
Obinutuzumab+Chemotherapy
82.1
Complete Response (CR) at the End of Treatment, Investigator-AssessedSecondary· 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.
Without PET
Group
Value
95% CI
Rituximab+Chemotherapy
33.9
Obinutuzumab+Chemotherapy
35.4
With PET
Group
Value
95% CI
Rituximab+Chemotherapy
59.1
Obinutuzumab+Chemotherapy
56.5
Complete Response (CR) at the End of Treatment, IRC-AssessedSecondary· 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.
Without PET
Group
Value
95% CI
Rituximab+Chemotherapy
34.4
Obinutuzumab+Chemotherapy
39.1
With PET
Group
Value
95% CI
Rituximab+Chemotherapy
65.3
Obinutuzumab+Chemotherapy
66.7
Median Time to Event-Free Survival (EFS), Investigator-AssessedSecondary· 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 measura
Group
Value
95% CI
Rituximab+Chemotherapy
74.5
NA – NA
Obinutuzumab+Chemotherapy
68.3
68.3 – NA
Median Time to Disease-Free Survival (DFS), Investigator-AssessedSecondary· 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 a
Group
Value
95% CI
Rituximab+Chemotherapy
NA
NA – NA
Obinutuzumab+Chemotherapy
65.4
NA – NA
Duration of Response (DOR), Investigator-AssessedSecondary· 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
Group
Value
95% CI
Rituximab+Chemotherapy
71.9
NA – NA
Obinutuzumab+Chemotherapy
NA
65.4 – NA
Time to Next Anti-Lymphoma Treatment (TTNALT)Secondary· Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)
Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause.
Group
Value
95% CI
Rituximab+Chemotherapy
NA
74.5 – NA
Obinutuzumab+Chemotherapy
NA
NA – NA
Percentage of Participants With Adverse Events (AEs)Secondary· Baseline up to approximately 6.5 years (up to 31 January 2018)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Group
Value
95% CI
Rituximab+Chemotherapy
95.3
Obinutuzumab+Chemotherapy
98.1
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 years and 7 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m\^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
· Phase 2
· not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP)
· Phase 1
· not yet recruiting
NCT06965114 — Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia
· Phase 1, PHASE2
· recruiting
NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu
· Phase 3
· recruiting
Other recruiting trials for Diffuse Large B-Cell Lymphoma
Currently open trials in the same condition.
NCT06863402 — Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype
· Phase 2
· recruiting
NCT07200375 — An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
· recruiting
NCT07070648 — Study on Predicting Response to Standard First-Line Treatment in Diffuse Large B-Cell Lymphoma (DLBCL) Patients Using ct
· recruiting
NCT07001540 — Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola
· Phase 2
· recruiting
NCT06803693 — Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
· Phase 2
· recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O
· Phase 2
· not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in
· Phase 3
· recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations
· not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
· Phase 3
· recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric
· Phase 3
· recruiting
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: 12 April 2019
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/NCT01287741.