ClinicalTrials.gov
History of Changes for Study: 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)
Latest version (submitted April 8, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 31, 2011 None (earliest Version on record)
2 February 15, 2011 Study Status
3 March 15, 2011 Study Status
4 April 18, 2011 Study Status and Contacts/Locations
5 May 18, 2011 Contacts/Locations, Study Status and Oversight
6 June 15, 2011 Contacts/Locations and Study Status
7 July 19, 2011 Contacts/Locations and Study Status
8 August 10, 2011 Recruitment Status, Contacts/Locations and Study Status
9 September 19, 2011 Contacts/Locations and Study Status
10 October 14, 2011 Contacts/Locations and Study Status
11 November 15, 2011 Contacts/Locations and Study Status
12 December 5, 2011 Study Status and Contacts/Locations
13 January 17, 2012 Contacts/Locations, Study Status and Study Design
14 February 15, 2012 Contacts/Locations, Study Status and Study Design
15 February 16, 2012 Eligibility and Study Status
16 March 16, 2012 Contacts/Locations and Study Status
17 March 22, 2012 Contacts/Locations and Study Status
18 April 18, 2012 Contacts/Locations and Study Status
19 May 3, 2012 Study Status, Contacts/Locations, Eligibility, Study Description and Study Identification
20 May 21, 2012 Contacts/Locations and Study Status
21 June 4, 2012 Contacts/Locations, Study Status, Eligibility, Sponsor/Collaborators and Study Identification
22 July 5, 2012 Contacts/Locations, Study Status and Sponsor/Collaborators
23 July 17, 2012 Contacts/Locations and Study Status
24 August 15, 2012 Contacts/Locations and Study Status
25 September 19, 2012 Contacts/Locations and Study Status
26 October 10, 2012 Contacts/Locations and Study Status
27 November 1, 2012 Contacts/Locations and Study Status
28 November 15, 2012 Contacts/Locations and Study Status
29 December 3, 2012 Contacts/Locations and Study Status
30 January 3, 2013 Contacts/Locations and Study Status
31 January 7, 2013 Contacts/Locations and Study Status
32 January 14, 2013 Contacts/Locations and Study Status
33 January 21, 2013 Contacts/Locations and Study Status
34 January 31, 2013 Contacts/Locations and Study Status
35 February 4, 2013 Contacts/Locations and Study Status
36 February 11, 2013 Contacts/Locations and Study Status
37 February 19, 2013 Contacts/Locations and Study Status
38 February 25, 2013 Contacts/Locations and Study Status
39 March 4, 2013 Contacts/Locations and Study Status
40 March 11, 2013 Contacts/Locations and Study Status
41 March 18, 2013 Contacts/Locations and Study Status
42 March 25, 2013 Contacts/Locations and Study Status
43 April 1, 2013 Contacts/Locations and Study Status
44 April 8, 2013 Contacts/Locations and Study Status
45 April 15, 2013 Contacts/Locations and Study Status
46 April 22, 2013 Contacts/Locations and Study Status
47 April 29, 2013 Contacts/Locations and Study Status
48 May 7, 2013 Contacts/Locations and Study Status
49 May 13, 2013 Contacts/Locations and Study Status
50 July 1, 2013 Contacts/Locations and Study Status
51 July 9, 2013 Contacts/Locations and Study Status
52 July 16, 2013 Contacts/Locations and Study Status
53 July 23, 2013 Contacts/Locations and Study Status
54 July 29, 2013 Contacts/Locations and Study Status
55 August 5, 2013 Contacts/Locations and Study Status
56 August 13, 2013 Contacts/Locations and Study Status
57 August 19, 2013 Contacts/Locations and Study Status
58 August 26, 2013 Contacts/Locations and Study Status
59 September 4, 2013 Study Status and Contacts/Locations
60 September 9, 2013 Contacts/Locations and Study Status
61 September 12, 2013 Contacts/Locations and Study Status
62 September 18, 2013 Contacts/Locations and Study Status
63 September 25, 2013 Contacts/Locations and Study Status
64 October 7, 2013 Study Status and Contacts/Locations
65 October 8, 2013 Contacts/Locations and Study Status
66 October 17, 2013 Contacts/Locations and Study Status
67 October 21, 2013 Contacts/Locations and Study Status
68 October 28, 2013 Contacts/Locations and Study Status
69 November 4, 2013 Contacts/Locations and Study Status
70 November 13, 2013 Contacts/Locations and Study Status
71 November 18, 2013 Contacts/Locations and Study Status
72 November 25, 2013 Contacts/Locations and Study Status
73 December 3, 2013 Contacts/Locations and Study Status
74 December 9, 2013 Contacts/Locations and Study Status
75 December 17, 2013 Contacts/Locations and Study Status
76 January 6, 2014 Contacts/Locations and Study Status
77 January 13, 2014 Contacts/Locations and Study Status
78 January 20, 2014 Contacts/Locations, Arms and Interventions, Sponsor/Collaborators and Study Status
79 January 27, 2014 Contacts/Locations and Study Status
80 February 3, 2014 Contacts/Locations and Study Status
81 February 10, 2014 Contacts/Locations and Study Status
82 February 17, 2014 Contacts/Locations, Sponsor/Collaborators and Study Status
83 February 24, 2014 Contacts/Locations and Study Status
84 March 3, 2014 Contacts/Locations and Study Status
85 March 14, 2014 Contacts/Locations and Study Status
86 March 17, 2014 Contacts/Locations and Study Status
87 March 24, 2014 Contacts/Locations and Study Status
88 March 31, 2014 Contacts/Locations and Study Status
89 April 7, 2014 Study Status and Contacts/Locations
90 April 14, 2014 Contacts/Locations and Study Status
91 April 22, 2014 Contacts/Locations and Study Status
92 April 28, 2014 Contacts/Locations and Study Status
93 May 5, 2014 Study Status and Contacts/Locations
94 May 12, 2014 Contacts/Locations and Study Status
95 May 19, 2014 Contacts/Locations and Study Status
96 May 26, 2014 Contacts/Locations and Study Status
97 June 23, 2014 Contacts/Locations, Study Status and Study Description
98 June 30, 2014 Contacts/Locations and Study Status
99 July 7, 2014 Study Status and Contacts/Locations
100 July 14, 2014 Contacts/Locations and Study Status
101 July 21, 2014 Contacts/Locations and Study Status
102 August 4, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
103 August 11, 2014 Study Status
104 August 26, 2014 Arms and Interventions and Study Status
105 September 22, 2014 Study Status
106 October 6, 2014 Study Status
107 October 13, 2014 Study Status
108 October 20, 2014 Study Status
109 November 3, 2014 Contacts/Locations and Study Status
110 November 10, 2014 Contacts/Locations and Study Status
111 November 17, 2014 Study Status
112 November 24, 2014 Contacts/Locations and Study Status
113 December 1, 2014 Study Status
114 December 8, 2014 Contacts/Locations and Study Status
115 December 15, 2014 Contacts/Locations and Study Status
116 December 23, 2014 Contacts/Locations and Study Status
117 January 6, 2015 Study Status
118 January 12, 2015 Contacts/Locations, Study Description and Study Status
119 January 19, 2015 Contacts/Locations, Study Description and Study Status
120 February 5, 2015 Study Status, Contacts/Locations and Study Description
121 February 19, 2015 Study Status
122 February 23, 2015 Study Status
123 March 2, 2015 Study Status
124 March 9, 2015 Contacts/Locations and Study Status
125 March 16, 2015 Study Status
126 April 2, 2015 Contacts/Locations and Study Status
127 May 5, 2015 Study Status
128 May 11, 2015 Contacts/Locations and Study Status
129 May 29, 2015 Study Status
130 June 1, 2015 Study Status
131 July 1, 2015 Study Status
132 July 31, 2015 Contacts/Locations and Study Status
133 August 17, 2015 Study Status
134 October 20, 2016 Arms and Interventions, Outcome Measures, Contacts/Locations, Study Status, Study Identification, Eligibility, Conditions and Study Description
135 August 15, 2017 Study Status, Contacts/Locations, Outcome Measures, Arms and Interventions, Results and Eligibility
136 November 9, 2017 Study Status and Contacts/Locations
137 February 20, 2018 Recruitment Status, Contacts/Locations and Study Status
138 April 24, 2018 Contacts/Locations and Study Status
139 May 9, 2018 Study Status and Contacts/Locations
140 July 30, 2018 Contacts/Locations and Study Status
141 April 8, 2019 Recruitment Status, Outcome Measures, Adverse Events, Study Status, Participant Flow, Baseline Characteristics and Contacts/Locations
Comparison Format:
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Study NCT01287741
Submitted Date:  November 9, 2017 (v136)
Open or close this module Study Identification
Unique Protocol ID: BO21005
Brief 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)
Official Title: A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
Secondary IDs: 2010-024194-39
Open or close this module Study Status
Record Verification: November 2017
Overall Status: Active, not recruiting
Study Start: July 31, 2011
Primary Completion: April 29, 2016 [Actual]
Study Completion: January 31, 2018 [Anticipated]
First Submitted: January 31, 2011
First Submitted that
Met QC Criteria:		 January 31, 2011
First Posted: February 1, 2011 [Estimate]
Results First Submitted: April 7, 2017
Results First Submitted that
Met QC Criteria:		 August 15, 2017
Results First Posted: August 17, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:		 November 9, 2017
Last Update Posted: December 11, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators: Fondazione Italiana Linfomi - ETS
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Diffuse Large B-Cell Lymphoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1418 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Rituximab+Chemotherapy
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
 Drug: Rituximab
Rituximab at a dose of 375 mg/m^2, administered by intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles.
Other Names:
  • MabThera, Rituxan
Drug: Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Drug: Doxorubicin
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
Drug: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Drug: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Experimental: Obinutuzumab+Chemotherapy
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
 Drug: Obinutuzumab
Obinutuzumab 1000 mg IV infusion, administered on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, obinutuzumab was also infused on Days 8 and 15.
Other Names:
  • GA101, RO5072759
Drug: Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Drug: Doxorubicin
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
Drug: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Drug: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Progression-Free Survival (PFS), Investigator-Assessed
[ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 9 months) ]

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 Outcome Measures:
1. Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
[ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 9 months) ]

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 IRC 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).
2. Overall Survival (OS)
[ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 9 months) ]

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. Reported is the percentage of participants with event.
3. Overall Response Rate (ORR), Investigator-Assessed
[ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 9 months) ]

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.
4. Overall Response Rate (ORR), IRC-Assessed
[ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 9 months) ]

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.
5. Complete Response (CR) at the End of Treatment, Investigator-Assessed
[ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 9 months) ]

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.
6. Complete Response (CR) at the End of Treatment, IRC-Assessed
[ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 9 months) ]

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.
7. Event-Free Survival (EFS), Investigator-Assessed
[ Time Frame: Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, to data cut-off (up to approximately 4 years and 9 months) ]

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. Reported is the percentage of participants with event.
8. Disease-Free Survival (DFS), Investigator-Assessed
[ Time Frame: Baseline up to death or disease progression, whichever occurred first, to data cut-off (up to approximately 4 years and 9 months) ]

Disease-free survival was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/relapse or death from any cause on the basis of investigator assessments with the 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. Reported is the percentage of participants with event.
9. Duration of Response (DOR), Investigator-Assessed
[ Time Frame: Baseline up to death or disease progression, whichever occurs first, to data cut-off (up to approximately 4 years and 9 months) ]

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%.
10. Time to Next Anti-Lymphoma Treatment (TTNALT)
[ Time Frame: Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, to data cut-off (up to approximately 4 years and 9 months) ]

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.
11. Percentage of Participants With Adverse Events (AEs)
[ Time Frame: Baseline up to data cut-off (up to approximately 4 years and 9 months) ]

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.
12. Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
[ Time Frame: Pre-dose (Hour 0) on Cycle (C) 1 Day (D) 1, C4D1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days) ]

The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.
13. Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
[ Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 4 years and 9 months, (cycle length = 21 days) ]

The FACT-Lym subscale was developed to assess health-related quality of life in patients with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.
14. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
[ Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 4 years and 9 months, (cycle length = 21 days) ]

The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.
15. Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
[ Time Frame: C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days) ]

Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Previously untreated CD20-positive DLBCL
  • At least 1 bi-dimensionally measurable lesion (greater than [>]1.5 centimeters [cm] in its largest dimension on the computed tomography [CT] scan)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate hematological function
  • Low-intermediate, high-intermediate or high-risk International Prognostic Index (IPI) score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion greater than equal to (>/=) 7.5 cm)
  • Left ventricular ejection fraction (LVEF) >/=50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or to any component of CHOP or obinutuzumab
  • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
  • Participants with transformed lymphoma and participants with follicular lymphoma IIIB
  • Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
  • Prior treatment with cytotoxic drugs or rituximab for another condition (for example, rheumatoid arthritis) or prior use of an anti-CD20 antibody
  • Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
  • Corticosteroid use of >30 milligrams per day (mg/day) of prednisone or equivalent, for purposes other than lymphoma symptom control
  • Primary central nervous system (CNS) lymphoma and secondary CNS involvement by lymphoma, mantle-cell lymphoma (MCL), or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL
Open or close this module Contacts/Locations
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Ironwood Cancer TX & Rsch Ctrs
Chandler, Arizona, United States, 85224
Arizona Oncology
Tucson, Arizona, United States, 85704
United States, California
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States, 92008
cCare
Encinitas, California, United States, 92024
UCLA - School of Medicine; Division of Hematology/Oncology
Los Angeles, California, United States, 90095-6984
United States, Colorado
Rocky Mountain Cancer Center - Aurora
Aurora, Colorado, United States, 80012
United States, Florida
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, United States, 33901-8101
Florida Cancer Specialists; Saint Petersburg
Saint Petersburg, Florida, United States, 33719
United States, Georgia
Central Georgia Cancer Care PC
Macon, Georgia, United States, 31201
United States, Illinois
Illinois Cancer Care, P.C. - Galesburg
Galesburg, Illinois, United States, 61401
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, United States, 60435
Cancer Care & Hematology; Specialists of Chicagoland
Niles, Illinois, United States, 60714
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Maine
Mercy Oncology / Hematology Center; Oncology
Portland, Maine, United States, 04102
United States, Minnesota
Park Nicollet Clin-Cancer Ctr
Saint Louis Park, Minnesota, United States, 55426
Minnesota Oncology Hematology Woodbury
Woodbury, Minnesota, United States, 55125
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
United States, North Carolina
Mecklenburg Medical Group Charlotte
Charlotte, North Carolina, United States, 28204
Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Signal Point Clinical; Research Center, LLC
Middletown, Ohio, United States, 45042
Cleveland CL N Coast Cancer Cr
Sandusky, Ohio, United States, 44870
United States, Oregon
Willamette Valley Cancer Insitute and Research Center
Springfield, Oregon, United States, 97477
United States, South Carolina
Medical University of SC (MUSC)
Charleston, South Carolina, United States, 29425
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, United States, 37404
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, Pa - Amarillo
Amarillo, Texas, United States, 79106
Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas, United States, 76104
MD Anderson Cancer Center Department of Lymphoma & Myeloma
Houston, Texas, United States, 77030
Cancer Care Centers of South Texas-HOAST - San Antonio
New Braunfels, Texas, United States, 78130
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Virginia Cancer Specialists - Winchester
Winchester, Virginia, United States, 22601
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States, 98801
Argentina
Instituto Damic
Cordoba, Argentina, X5003DCE
Sanatorio Britanico: Hematologia
Rosario, Argentina, 2000
Sanatorio Parque de Rosario
Rosario, Argentina, S2000DSV
Australia, Queensland
Cairns Base Hospital; Cancer Care Centre
Cairns, Queensland, Australia, 4870
Australia, Victoria
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, Australia, 3199
Monash Medical Centre; Haematology
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, Austria, 6020
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Wien, Austria, 1090
Brazil, RS
Hospital Mae de Deus
Porto Alegre, RS, Brazil, 90470-340
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Brazil, SC
Centro de Pesquisas Oncologicas - CEPON
Florianopolis, SC, Brazil, 88034-000
Brazil, SP
Instituto de Ensino e Pesquisa Sao Lucas - IEP
Sao Paulo, SP, Brazil, 01236-030
Hospital Santa Marcelina;Oncologia
Sao Paulo, SP, Brazil, 08270-070
Canada, Alberta
Tom Baker Cancer Centre; Dept of Medicine
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
QEII HSC; Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Humber River Hospital
Toronto, Ontario, Canada, M3M 0B2
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, Canada, H1T 2M4
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal, Quebec, Canada, H2L 4M1
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, Canada, H3A 1A1
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
Hopital de L'Enfant-Jesus; Hematology
Quebec City, Quebec, Canada, G1J 1Z4
Centre de sante et de services sociaux Rimouski Neigette
Rimouski, Quebec, Canada, G5L 5T1
Canada, Saskatchewan
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, Canada, S7N 4H4
China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China, 100021
Peking University First Hospital
Beijing, China, 100034
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, China, 100071
Beijing Cancer Hospital
Beijing, China, 100142
Beijing Hospital of Ministry of Health; Hematology
Beijing, China, 100730
General Hospital of Chinese PLA; Department of Hematology
Beijing, China, 100853
the First Hospital of Jilin University
Changchun, China, 130021
Hu Nan Provincial Cancer Hospital
Changsha, China, 410006
Fujian Medical University Union Hospital
Fujian, China, 350001
Fujian Cancer Hospital
Fuzhou, China, 350014
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060
Guangdong General Hospital
Guangzhou City, China, 510080
The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang
Hangzhou, China, 310003
Harbin Medical University Cancer Hospital
Harbin, China, 150081
The Second Affiliated Hospital to Nanchang University
Nanchang, China, 330006
Jiangsu Cancer Hospital
Nanjing, China, 210009
Jiangsu Province Hospital
Nanjing, China, 210036
The First Affiliate Hospital of Guangxi Medical University
Nanning, China, 530021
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Changhai Hospital of Shanghai
Shanghai, China, 200433
The First Hospital of China Medical University
Shenyang, China, 110001
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Tianjin Cancer Hospital
Tianjin, China, 300060
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, China, 430022
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, China, 430023
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, China, 710038
Colombia
Fundacion Cardioinfantil
Bogota, Colombia
Organizacion Sanitas Internacional
Bogota, Colombia
FOSCAL
Floridablanca, Colombia
Czechia
Fakultni nemocnice Brno; Interni hematoonkologicka klinika
Brno, Czechia, 625 00
Fn Hr. Kralove; IV. Interni Hematologicka Klinika
Hradec Kralove, Czechia, 500 05
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
Praha 2, Czechia, 128 08
Denmark
Righospitalet, Hæmatologisk Klinik
København Ø, Denmark, 2100
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
Roskilde, Denmark, 4000
Aarhus Universitetshospital, Hæmatologisk Afdeling R
Ã…rhus, Denmark, 8000
Germany
Uniklinik RWTH Aachen; Med. Klinik IV; Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammz
Aachen, Germany, 52074
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, Germany, 10707
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307
Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
Erlangen, Germany, 91054
Klinik der Justus-Liebig-Universität; Innere Medizin
Gießen, Germany, 35392
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
Heidelberg, Germany, 69120
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Würzburg, Germany, 97080
Hong Kong
Pamela Youde Nethersole Eastern Hospital; Department of Medicine
Hong Kong, Hong Kong
Queen Mary Hospital; Dept of Medicine
Hong Kong, Hong Kong
Hungary
Semmelweis University, First Dept of Medicine
Budapest, Hungary, 1083
National Institute of Oncology, A Dept of Internal Medicine
Budapest, Hungary, 1122
University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B
Debrecen, Hungary, 4032
Petz Aladar Megyei Korhaz; Hematologia
Gyor, Hungary, 9024
Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
Kaposvar, Hungary, 7400
University of Pecs, I st Dept of Internal Medicine
Pecs, Hungary, 7624
University of Szeged, II Dept of Internal Medicine
Szeged, Hungary, 6720
Italy, Calabria
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, Italy, 89100
Italy, Campania
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
Napoli, Campania, Italy, 80131
Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
Napoli, Campania, Italy, 80131
Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia
Pagani (Sa), Campania, Italy, 84016
Italy, Emilia-Romagna
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy, 40138
AO Santa Maria Nuova; U.O. Day Hospital di Oncologi
Reggio Emilia, Emilia-Romagna, Italy, 42100
Italy, Friuli-Venezia Giulia
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Udine, Friuli-Venezia Giulia, Italy, 33100
Italy, Lazio
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
Roma, Lazio, Italy, 00161
Italy, Liguria
A.O. Universitaria S. Martino Di Genova; Ematologia 1
Genova, Liguria, Italy, 16132
Italy, Lombardia
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardia, Italy, 25123
Hospital San Raffaele
Milano, Lombardia, Italy, 20132
Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
Milano, Lombardia, Italy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
Milano, Lombardia, Italy, 20141
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardia, Italy, 27100
Italy, Piemonte
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
Alessandria, Piemonte, Italy, 15121
Ospedali Riuniti del Canavese
Ivrea, Piemonte, Italy, 10015
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
Novara, Piemonte, Italy, 28100
Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii
Orbassano, Piemonte, Italy, 10043
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Torino, Piemonte, Italy, 10126
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Torino, Piemonte, Italy, 10126
Italy, Puglia
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Puglia, Italy, 70124
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
San Giovanni Rotondo, Puglia, Italy, 71013
Az. Osp. C. Panico; Rep. Ematologia E Trapianto
Tricase - LE, Puglia, Italy, 73039
Italy, Sicilia
Azienda Ospedaliero Univ
Catania, Sicilia, Italy, 95124
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicilia, Italy, 98165
Italy, Toscana
Azienda Ospedaliera Univ
Firenze, Toscana, Italy, 50141
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Toscana, Italy, 56100
Italy, Umbria
Az. Osp. S. Maria; Dept. Di Oncologia Medica
Terni, Umbria, Italy, 05100
Italy, Veneto
Ospedale Ca Foncello; Ematologia
Treviso, Veneto, Italy, 31100
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
Verona, Veneto, Italy, 37130
Ospedale Di Vicenza; Nefrologia, Ematologia
Vicenza, Veneto, Italy, 36100
Japan
Nagoya Daini Red Cross Hospital; Hematology & Oncology
Aichi, Japan, 466-8650
Chiba University Hospital; Hematology
Chiba, Japan, 260-8670
Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine
Fukuoka, Japan, 812-8582
Kurume University Hospital; Hematology and Oncology
Fukuoka, Japan, 830-0011
Gifu University Hospital; First Department of Internal Medicine
Gifu, Japan, 501-1194
Hokkaido University Hospital; Hematology
Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital; Hematology
Hyogo, Japan, 650-0047
Iwate Medical University Hospital;Hematology and Oncology
Iwate, Japan, 020-8505
Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease
Kanagawa, Japan, 236-0004
Kyoto University Hospital; Department of Hematology/Oncology
Kyoto, Japan, 606-8507
Niigata Cancer Center Hospital; Internal Medicine
Niigata, Japan, 951-8566
Kurashiki Central Hospital; Hematology
Okayama, Japan, 710-8602
Osaka City University Hospital; Hematology
Osaka, Japan, 545-8586
Osaka University Hospital; Hematology and Oncology
Osaka, Japan, 565-0871
Kindai University Hospital; Hematology and Rheumatology
Osaka, Japan, 589-8511
Shimane University Hospital;Hematology
Shimane, Japan, 693-8501
Jichi Medical University Hospital; Hematology
Tochigi, Japan, 329-0498
National Cancer Center Hospital; Hematology
Tokyo, Japan, 104-0045
Toranomon Hospital; Hematology
Tokyo, Japan, 105-8470
Nippon Medical School Hospital; Hematology
Tokyo, Japan, 113-8603
The Cancer Institute Hospital of JFCR; Hematology Oncology
Tokyo, Japan, 135-8550
Korea, Republic of
National Cancer Center
Gyeonggi-do, Korea, Republic of, 10408
Chonnam National University Hwasun Hospital
Jeollanam-do, Korea, Republic of, 58128
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Yonsei University Severance Hospital; Medical Oncology
Seoul, Korea, Republic of, 120-752
St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
Seoul, Korea, Republic of, 137-701
Mexico
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
Chihuahua, Mexico, 31000
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
Monterrey, Mexico, 64460
Oaxaca Site Management Organization
Oaxaca, Mexico, 68000
Centro de Estudios Clinicos de Queretaro, SC
Queretaro, Mexico, 76000
Panama
Centro Hemato Oncologico Paitilla
Panama City, Panama, 083200752
Peru
Instituto;Oncologico Miraflores
Lima, Peru, 18
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
Clinica de Especialidades Medicas
Lima, Peru, Lima 41
Poland
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, Poland, 36-200
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk, Poland, 80-952
Medical University of Lodz; Hematology
Lodz, Poland, 93-510
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
Lublin, Poland, 20-081
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warszawa, Poland, 02-781
Medical Uni of Wroclaw; Hematology
Wroclaw, Poland, 50-367
Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan, Russian Federation, 420029
Blokhin Cancer Research Center; Clinical Oncology
Moscow, Russian Federation, 115478
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod, Russian Federation, 603126
Penza Regional Oncology Dispensary
Penza, Russian Federation, 440071
Republican Clinical Hospital n.a. Baranov; Haematology
Petrozavodsk, Russian Federation, 185019
Research Inst. of Hematology & Blood Transfusion ; Hematology
St Petersburg, Russian Federation, 191024
Serbia
Institute of Hematology
Belgrade, Serbia, 11000
Clinical Center Vojvodine; Clinic for Hematology
Novi Sad, Serbia, 21000
Slovakia
National Oncology Inst. ; Dept. of Haematology
Bratislava, Slovakia, 833 10
South Africa
Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant
Cape Town, South Africa, 7800
Mary Potter Oncology Centre
Groenkloof, South Africa, 0181
Medical Oncology Centre of Rosebank; Oncology
Johannesburg, South Africa, 2196
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
Parktown, Johannesburg, South Africa, 2193
Drs Thomson, Brittain an Partners Inc
Pretoria, South Africa, 0044
Spain
Hospital del Mar; Servicio de Hematologia
Barcelona, Spain, 08003
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Hospital Duran i Reynals; Servicio de Hematologia
Barcelona, Spain, 08907
Hospital Ramon y Cajal; Servicio de Hematologia
Madrid, Spain, 28034
Complejo Hospitalario de Pontevedra; Servicio de Oncologia
Pontevedra, Spain, 36002
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, Spain, 45004
Spain, Navarra
Hospital de Navarra, Servicio de Hematología
Pamplona, Navarra, Spain, 31008
Spain, Tarragona
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
Reus, Tarragona, Spain, 43204
Switzerland
Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
Aarau, Switzerland, 5001
Ospedale San Giovanni; Oncologia
Bellinzona, Switzerland, 6500
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, Switzerland, 7000
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich, Switzerland, 8091
Taiwan
Veterans General Hospital; Division of Oncology
Taipei, Taiwan, 00112
National Taiwan Universtiy Hospital; Division of Hematology
Taipei, Taiwan, 100
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, Taiwan, 112
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan, Taiwan, 333
Thailand
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand, 10330
National Cancer Inst.
Bangkok, Thailand, 10400
Rajavithi Hospital; Medicine
Bangkok, Thailand, 10400
Ramathibodi Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand, 10400
Siriraj Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand, 10700
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Khon Kaen, Thailand, 40002
United Kingdom
Aberdeen Royal Infirmary; Haematology - Ward 16
Aberdeen, United Kingdom, AB25 2ZN
Birmingham Heartlands Hospital; Department of Haematology
Birmingham, United Kingdom, B9 5SS
Addenbrookes Hospital; Haematology
Cambridge, United Kingdom, CB2 0QQ
The HOPE Clinical Trials Unit
Leicester, United Kingdom, LE1 5WW
New Cross Hospital; Dept. Of Haematology
Wolverhampton, United Kingdom, WV10 0QP
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
Study Results
Open or close this module Participant Flow
Recruitment Details
Pre-assignment Details Eleven participants withdrew from the study after randomization but prior to receiving study treatment.
 
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Arm/Group Description Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Period Title: Overall Study
Started 712 706
Completed 0 0
Not Completed 712 706
Reason Not Completed
Withdrawal by Subject 25 22
Protocol Violation 1 0
Physician Decision 12 19
Non-compliance 2 3
Lost to Follow-up 5 8
Death 31 38
Adverse Event 3 4
Continued in the study 446 455
Progressive disease 173 148
Reason not specified 14 9
Open or close this module Baseline Characteristics
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+ChemotherapyTotal
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Total of all reporting groups
Overall Number of Baseline Participants 712 706 1418
Baseline Analysis Population Description
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed712 Participants706 Participants1418 Participants
59.1(13.6)59.4(13.3)59.2(13.5)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed712 Participants706 Participants1418 Participants
Female
329
46.21%
337
47.73%
666
46.97%
Male
383
53.79%
369
52.27%
752
53.03%
Open or close this module Outcome Measures
1. Primary Outcome:
Title Progression-Free Survival (PFS), Investigator-Assessed
Description 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).
Time Frame Baseline up to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Measure Type: Number
Unit of Measure: percentage of participants
30.2 28.5
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionRituximab+Chemotherapy, Obinutuzumab+Chemotherapy
Comments[Not specified]
Type of Statistical TestSuperiority or Other
Comments[Not specified]
Statistical Test of HypothesisP-Value0.3868
Comments[Not specified]
MethodLog Rank
CommentsStratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.92
Confidence Interval(2-sided) 95%
0.76 to 1.11
Estimation Comments[Not specified]
2. Secondary Outcome:
Title Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
Description 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 IRC 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).
Time Frame Baseline up to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Measure Type: Number
Unit of Measure: percentage of participants
26.1 24.2
Statistical Analysis 1
Statistical Analysis OverviewComparison Group SelectionRituximab+Chemotherapy, Obinutuzumab+Chemotherapy
Comments[Not specified]
Type of Statistical TestSuperiority or Other
Comments[Not specified]
Statistical Test of HypothesisP-Value0.2736
Comments[Not specified]
MethodLog Rank
CommentsStratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.89
Confidence Interval(2-sided) 95%
0.72 to 1.10
Estimation Comments[Not specified]
3. Secondary Outcome:
Title Overall Survival (OS)
Description 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. Reported is the percentage of participants with event.
Time Frame Baseline up to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Measure Type: Number
Unit of Measure: percentage of participants
17.7 17.8
4. Secondary Outcome:
Title Overall Response Rate (ORR), Investigator-Assessed
Description 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.
Time Frame Baseline up to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Measure Type: Number
Unit of Measure: percentage of participants
Without PET (n= 712, 706)
80.3 81.7
With PET (n=665, 669)
77.9 77.4
5. Secondary Outcome:
Title Overall Response Rate (ORR), IRC-Assessed
Description 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.
Time Frame Baseline up to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Measure Type: Number
Unit of Measure: percentage of participants
Without PET (n= 712, 706)
80.2 82.3
With PET (n=665, 669)
81.1 82.1
6. Secondary Outcome:
Title Complete Response (CR) at the End of Treatment, Investigator-Assessed
Description 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.
Time Frame Baseline up to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Measure Type: Number
Unit of Measure: percentage of participants
Without PET (n= 712, 706)
33.8 35.1
With PET (n=665, 669)
59.5 56.7
7. Secondary Outcome:
Title Complete Response (CR) at the End of Treatment, IRC-Assessed
Description 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.
Time Frame Baseline up to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Measure Type: Number
Unit of Measure: percentage of participants
Without PET (n= 712, 706)
34.4 39.1
With PET (n=665, 669)
65.3 66.7
8. Secondary Outcome:
Title Event-Free Survival (EFS), Investigator-Assessed
Description 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. Reported is the percentage of participants with event.
Time Frame Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Measure Type: Number
Unit of Measure: percentage of participants
35.1 33.4
9. Secondary Outcome:
Title Disease-Free Survival (DFS), Investigator-Assessed
Description Disease-free survival was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/relapse or death from any cause on the basis of investigator assessments with the 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. Reported is the percentage of participants with event.
Time Frame Baseline up to death or disease progression, whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed369 397
Measure Type: Number
Unit of Measure: percentage of participants
17.3 19.4
10. Secondary Outcome:
Title Duration of Response (DOR), Investigator-Assessed
Description 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%.
Time Frame Baseline up to death or disease progression, whichever occurs first, to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed642 659
Median (95% Confidence Interval)
Unit of Measure: months
53.0(NA to NA) [1] NA(48.1 to NA) [2]
[1]NA Explanation: There were not enough events to calculate the confidence intervals.
[2]NA Explanation: There were not enough events to calculate the median and the upper limit of the confidence interval.
11. Secondary Outcome:
Title Time to Next Anti-Lymphoma Treatment (TTNALT)
Description 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.
Time Frame Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Median (95% Confidence Interval)
Unit of Measure: months
NA(NA to NA) [1] NA(NA to NA) [1]
[1]NA Explanation: Median and 95% confidence interval were not calculable, due to low number of observations.
12. Secondary Outcome:
Title Percentage of Participants With Adverse Events (AEs)
Description 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.
Time Frame Baseline up to data cut-off (up to approximately 4 years and 9 months)
Outcome Measure Data
Analysis Population Description
The safety analysis population included all participants who received at least one dose of study drug.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed703 704
Measure Type: Number
Unit of Measure: percentage of participants
94.9 97.6
13. Secondary Outcome:
Title Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Description The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.
Time Frame Pre-dose (Hour 0) on Cycle (C) 1 Day (D) 1, C4D1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)
Outcome Measure Data
Analysis Population Description
The safety analysis population included all participants who received at least one dose of study drug.
 
Arm/Group TitleObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed100
Measure Type: Number
Unit of Measure: percentage of participants
Screening (n=70)
2.9
Cycle 1 Day 1 (n=29)
0
Cycle 4 Day 1 (n=89)
0
Study Completion / Early Discontinuation (n=67)
0
Follow-Up Month 6 (n=41)
0
Follow-Up Month 12 (n=40)
0
Follow-Up Month 18 (n=27)
0
Follow-Up Month 24 (n=25)
0
Follow-Up Month 30 (n=19)
0
Follow-Up Completion/ Early Discontinuation (n=6)
0
14. Secondary Outcome:
Title Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Description The FACT-Lym subscale was developed to assess health-related quality of life in patients with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.
Time Frame Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 4 years and 9 months, (cycle length = 21 days)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=607, 641)
45.36(10.15) 45.12(9.96)
Score Change, Cycle 3 Day 1 (n=553, 565)
3.84(8.69) 3.74(9.23)
Score Change, Study Compl./Discont. (n=526, 529)
5.04(10.26) 4.43(11.09)
Score Change, Follow-Up Month 12 (n=370, 412)
6.38(10.13) 6.21(10.49)
Score Change, Follow-Up Month 24 (n=232, 248)
7.79(10.26) 5.95(10.38)
Score Change, Follow-Up Month 30 (n=0, 1)
NA(NA) [1] 25.00(NA) [2]
Score Change, Follow-Up Month 36 (n=94, 100)
7.13(10.18) 6.88(10.74)
Score Change, Follow-Up Month 48 (n=6, 10)
3.06(4.67) 4.00(7.80)
Score Change, Follow-Up Term./Compl. (n=50, 48)
3.54(12.57) 3.60(11.49)
[1]NA Explanation: No participants were evaluable.
[2]NA Explanation: There was only one reported value; therefore, no standard deviation.
15. Secondary Outcome:
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Description The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.
Time Frame Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 4 years and 9 months, (cycle length = 21 days)
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
 
Arm/Group TitleRituximab+ChemotherapyObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed712 706
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=610, 643)
59.78(24.47) 58.51(25.22)
Change Baseline, Cycle 1 Day 1 (n=0, 0)
NA(NA) [1] NA(NA) [1]
Change Baseline, Cycle 3 Day 1 (n=555, 567)
6.28(24.08) 7.52(25.95)
Change Baseline, Study Completion (n=526, 532)
9.97(26.14) 10.29(30.16)
Change Baseline, Follow-Up Month 12 (n=370, 414)
12.73(26.32) 13.89(30.02)
Change Baseline, Follow-Up Month 24 (n=234, 247)
16.84(26.30) 14.74(29.57)
Change Baseline, Follow-Up Month 30 (n=0, 1)
NA(NA) [1] 58.33(NA) [2]
Change Baseline, Follow-Up Month 36 (n=94, 99)
14.36(31.40) 14.31(31.34)
Change Baseline, Follow-Up Month 48 (n=7, 10)
-4.76(39.04) 14.17(33.34)
Change Baseline, Follow-Up Completion (n=50, 48)
1.17(33.25) -0.69(24.06)
[1]NA Explanation: NA = NE = Not estimable based on 0 participants evaluated
[2]NA Explanation: NA = NE = Not estimable based on 1 participant evaluated
16. Secondary Outcome:
Title Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Description Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.
Time Frame C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)
Outcome Measure Data
Analysis Population Description
40 Japanese participants in the Obinutuzumab+Chemotherapy arm
 
Arm/Group TitleObinutuzumab+Chemotherapy
Arm/Group DescriptionParticipants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Overall Number of Participants Analyzed40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (μg/mL)
Cycle 1, Day 8 pre-infusion
174(38.7)
Cycle 1, Day 15 pre-infusion
320(39.2)
Cycle 2, Day 1 pre-infusion
431(39.8)
Cycle 4, Day 1 pre-infusion
352(42.1)
Cycle 6, Day 1 pre-infusion
378(45.9)
Cycle 8, Day 1 pre-infusion
478(43.9)
Cycle 1, Day 1 post-infusion
435(32.3)
Cycle 1, Day 1 20-28 hours after end of infusion
259(56.3)
Cycle 1, Day 1 66-80 hours after end of infusion
219(51.2)
Cycle 1, Day 8 post-infusion
578(37.8)
Cycle 1, Day 15 post-infusion
718(32.9)
Cycle 2, Day 1 post-infusion
938(31.3)
Cycle 4, Day 1 post-infusion
817(28.6)
Cycle 6, Day 1 post-infusion
813(32.6)
Cycle 8, Day 1 post-infusion
881(35.9)
Open or close this module Adverse Events
 
Time Frame 4 years and 9 months
Adverse Event Reporting Description The safety analysis population included all participants who received at least one dose of study drug (i.e., obinutuzumab, rituximab, or CHOP).
 
Arm/Group Title Rituximab+Chemotherapy Obinutuzumab+Chemotherapy
Arm/Group Description Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
All-Cause Mortality
  Rituximab+ChemotherapyObinutuzumab+Chemotherapy
 Affected / At Risk (%)Affected / At Risk (%)
Total / /
Serious Adverse Events
  Rituximab+ChemotherapyObinutuzumab+Chemotherapy
 Affected / At Risk (%)Affected / At Risk (%)
Total 264 / 703 (37.55%)300 / 704 (42.61%)
Blood and lymphatic system disorders
Anaemia † A 6 / 703 (0.85%)9 / 704 (1.28%)
Febrile neutropenia † A 72 / 703 (10.24%)81 / 704 (11.51%)
Haemolytic anaemia † A 1 / 703 (0.14%)0 / 704 (0%)
Histiocytosis haematophagic † A 0 / 703 (0%)1 / 704 (0.14%)
Immune thrombocytopenic purpura † A 0 / 703 (0%)1 / 704 (0.14%)
Leukopenia † A 5 / 703 (0.71%)10 / 704 (1.42%)
Neutropenia † A 40 / 703 (5.69%)52 / 704 (7.39%)
Splenic haematoma † A 0 / 703 (0%)1 / 704 (0.14%)
Thrombocytopenia † A 2 / 703 (0.28%)8 / 704 (1.14%)
Cardiac disorders
Acute coronary syndrome † A 0 / 703 (0%)1 / 704 (0.14%)
Acute myocardial infarction † A 5 / 703 (0.71%)1 / 704 (0.14%)
Angina pectoris † A 2 / 703 (0.28%)0 / 704 (0%)
Atrial fibrillation † A 4 / 703 (0.57%)9 / 704 (1.28%)
Atrial flutter † A 1 / 703 (0.14%)1 / 704 (0.14%)
Bradycardia † A 0 / 703 (0%)1 / 704 (0.14%)
Cardiac arrest † A 1 / 703 (0.14%)1 / 704 (0.14%)
Cardiac failure † A 3 / 703 (0.43%)7 / 704 (0.99%)
Cardiac failure congestive † A 1 / 703 (0.14%)3 / 704 (0.43%)
Cardiac perforation † A 0 / 703 (0%)1 / 704 (0.14%)
Cardiomyopathy † A 0 / 703 (0%)1 / 704 (0.14%)
Cardiopulmonary failure † A 1 / 703 (0.14%)0 / 704 (0%)
Congestive cardiomyopathy † A 1 / 703 (0.14%)0 / 704 (0%)
Coronary artery disease † A 1 / 703 (0.14%)0 / 704 (0%)
Coronary artery thrombosis † A 0 / 703 (0%)1 / 704 (0.14%)
Hypertensive heart disease † A 0 / 703 (0%)1 / 704 (0.14%)
Left ventricular dysfunction † A 0 / 703 (0%)1 / 704 (0.14%)
Mitral valve disease † A 0 / 703 (0%)1 / 704 (0.14%)
Myocardial infarction † A 2 / 703 (0.28%)3 / 704 (0.43%)
Myocardial ischaemia † A 1 / 703 (0.14%)0 / 704 (0%)
Pericardial effusion † A 0 / 703 (0%)1 / 704 (0.14%)
Supraventricular tachycardia † A 1 / 703 (0.14%)0 / 704 (0%)
Ventricular flutter † A 0 / 703 (0%)1 / 704 (0.14%)
Ear and labyrinth disorders
Vertigo positional † A 0 / 703 (0%)1 / 704 (0.14%)
Endocrine disorders
Addison's disease † A 0 / 703 (0%)1 / 704 (0.14%)
Goitre † A 1 / 703 (0.14%)0 / 704 (0%)
Eye disorders
Cataract † A 2 / 703 (0.28%)0 / 704 (0%)
Lacrimation increased † A 0 / 703 (0%)1 / 704 (0.14%)
Gastrointestinal disorders
Abdominal pain † A 6 / 703 (0.85%)4 / 704 (0.57%)
Abdominal pain upper † A 1 / 703 (0.14%)2 / 704 (0.28%)
Anal fistula † A 1 / 703 (0.14%)0 / 704 (0%)
Colitis † A 2 / 703 (0.28%)2 / 704 (0.28%)
Constipation † A 1 / 703 (0.14%)0 / 704 (0%)
Diarrhoea † A 6 / 703 (0.85%)4 / 704 (0.57%)
Dysphagia † A 0 / 703 (0%)1 / 704 (0.14%)
Enteritis † A 1 / 703 (0.14%)0 / 704 (0%)
Gastric haemorrhage † A 2 / 703 (0.28%)1 / 704 (0.14%)
Gastric perforation † A 3 / 703 (0.43%)1 / 704 (0.14%)
Gastric ulcer † A 0 / 703 (0%)1 / 704 (0.14%)
Gastritis † A 0 / 703 (0%)1 / 704 (0.14%)
Gastritis haemorrhagic † A 0 / 703 (0%)1 / 704 (0.14%)
Gastrointestinal haemorrhage † A 3 / 703 (0.43%)2 / 704 (0.28%)
Haematemesis † A 0 / 703 (0%)1 / 704 (0.14%)
Haematochezia † A 1 / 703 (0.14%)0 / 704 (0%)
Haemorrhoids † A 0 / 703 (0%)2 / 704 (0.28%)
Ileal perforation † A 0 / 703 (0%)1 / 704 (0.14%)
Ileus † A 2 / 703 (0.28%)1 / 704 (0.14%)
Ileus paralytic † A 1 / 703 (0.14%)0 / 704 (0%)
Impaired gastric emptying † A 1 / 703 (0.14%)0 / 704 (0%)
Inguinal hernia † A 1 / 703 (0.14%)1 / 704 (0.14%)
Intestinal ischaemia † A 0 / 703 (0%)1 / 704 (0.14%)
Intestinal obstruction † A 4 / 703 (0.57%)2 / 704 (0.28%)
Intestinal perforation † A 2 / 703 (0.28%)3 / 704 (0.43%)
Large intestine polyp † A 0 / 703 (0%)2 / 704 (0.28%)
Lower gastrointestinal haemorrhage † A 1 / 703 (0.14%)0 / 704 (0%)
Melaena † A 1 / 703 (0.14%)0 / 704 (0%)
Nausea † A 2 / 703 (0.28%)1 / 704 (0.14%)
Odynophagia † A 0 / 703 (0%)1 / 704 (0.14%)
Pancreatitis acute † A 0 / 703 (0%)1 / 704 (0.14%)
Pneumoperitoneum † A 0 / 703 (0%)1 / 704 (0.14%)
Small intestinal obstruction † A 1 / 703 (0.14%)2 / 704 (0.28%)
Small intestinal perforation † A 1 / 703 (0.14%)1 / 704 (0.14%)
Stomatitis † A 1 / 703 (0.14%)0 / 704 (0%)
Subileus † A 1 / 703 (0.14%)1 / 704 (0.14%)
Upper gastrointestinal haemorrhage † A 1 / 703 (0.14%)3 / 704 (0.43%)
Vomiting † A 2 / 703 (0.28%)2 / 704 (0.28%)
General disorders
Asthenia † A 4 / 703 (0.57%)2 / 704 (0.28%)
Axillary pain † A 0 / 703 (0%)1 / 704 (0.14%)
Chest pain † A 2 / 703 (0.28%)0 / 704 (0%)
Chills † A 1 / 703 (0.14%)2 / 704 (0.28%)
Death † A 2 / 703 (0.28%)3 / 704 (0.43%)
Extravasation † A 1 / 703 (0.14%)0 / 704 (0%)
Fatigue † A 5 / 703 (0.71%)4 / 704 (0.57%)
General physical health deterioration † A 1 / 703 (0.14%)2 / 704 (0.28%)
Hernia † A 0 / 703 (0%)1 / 704 (0.14%)
Hyperpyrexia † A 0 / 703 (0%)1 / 704 (0.14%)
Incarcerated hernia † A 0 / 703 (0%)1 / 704 (0.14%)
Malaise † A 0 / 703 (0%)2 / 704 (0.28%)
Mucosal inflammation † A 1 / 703 (0.14%)1 / 704 (0.14%)
Non-cardiac chest pain † A 2 / 703 (0.28%)0 / 704 (0%)
Oedema peripheral † A 0 / 703 (0%)2 / 704 (0.28%)
Pain † A 1 / 703 (0.14%)0 / 704 (0%)
Peripheral swelling † A 1 / 703 (0.14%)0 / 704 (0%)
Pyrexia † A 11 / 703 (1.56%)17 / 704 (2.41%)
Sudden death † A 1 / 703 (0.14%)1 / 704 (0.14%)
Hepatobiliary disorders
Bile duct obstruction † A 0 / 703 (0%)1 / 704 (0.14%)
Cholecystitis † A 2 / 703 (0.28%)1 / 704 (0.14%)
Cholecystitis acute † A 1 / 703 (0.14%)1 / 704 (0.14%)
Cholelithiasis † A 1 / 703 (0.14%)0 / 704 (0%)
Liver disorder † A 1 / 703 (0.14%)0 / 704 (0%)
Infections and infestations
Anal abscess † A 0 / 703 (0%)2 / 704 (0.28%)
Appendiceal abscess † A 0 / 703 (0%)1 / 704 (0.14%)
Appendicitis † A 3 / 703 (0.43%)1 / 704 (0.14%)
Atypical pneumonia † A 1 / 703 (0.14%)0 / 704 (0%)
Bacterial infection † A 1 / 703 (0.14%)0 / 704 (0%)
Bacterial sepsis † A 0 / 703 (0%)1 / 704 (0.14%)
Bronchitis † A 4 / 703 (0.57%)1 / 704 (0.14%)
Bronchopulmonary aspergillosis † A 1 / 703 (0.14%)1 / 704 (0.14%)
Candida sepsis † A 1 / 703 (0.14%)0 / 704 (0%)
Cellulitis † A 3 / 703 (0.43%)2 / 704 (0.28%)
Cholecystitis infective † A 0 / 703 (0%)1 / 704 (0.14%)
Clostridium difficile colitis † A 1 / 703 (0.14%)1 / 704 (0.14%)
Clostridium difficile infection † A 0 / 703 (0%)1 / 704 (0.14%)
Cytomegalovirus chorioretinitis † A 1 / 703 (0.14%)3 / 704 (0.43%)
Cytomegalovirus colitis † A 0 / 703 (0%)1 / 704 (0.14%)
Cytomegalovirus infection † A 2 / 703 (0.28%)0 / 704 (0%)
Device related infection † A 2 / 703 (0.28%)1 / 704 (0.14%)
Device related sepsis † A 0 / 703 (0%)1 / 704 (0.14%)
Diabetic foot infection † A 1 / 703 (0.14%)0 / 704 (0%)
Diarrhoea infectious † A 0 / 703 (0%)2 / 704 (0.28%)
Diverticulitis † A 0 / 703 (0%)1 / 704 (0.14%)
Enteritis infectious † A 1 / 703 (0.14%)0 / 704 (0%)
Enterocolitis infectious † A 0 / 703 (0%)1 / 704 (0.14%)
Escherichia sepsis † A 1 / 703 (0.14%)0 / 704 (0%)
Fungal infection † A 1 / 703 (0.14%)0 / 704 (0%)
Gastroenteritis † A 3 / 703 (0.43%)3 / 704 (0.43%)
H1N1 influenza † A 0 / 703 (0%)1 / 704 (0.14%)
Hepatitis B † A 0 / 703 (0%)1 / 704 (0.14%)
Herpes simplex † A 0 / 703 (0%)1 / 704 (0.14%)
Herpes virus infection † A 0 / 703 (0%)2 / 704 (0.28%)
Herpes zoster † A 3 / 703 (0.43%)4 / 704 (0.57%)
Herpes zoster disseminated † A 0 / 703 (0%)1 / 704 (0.14%)
Infected lymphocele † A 0 / 703 (0%)1 / 704 (0.14%)
Infection † A 0 / 703 (0%)2 / 704 (0.28%)
Infectious pleural effusion † A 0 / 703 (0%)2 / 704 (0.28%)
Infective glossitis † A 0 / 703 (0%)1 / 704 (0.14%)
Influenza † A 2 / 703 (0.28%)1 / 704 (0.14%)
Klebsiella sepsis † A 1 / 703 (0.14%)1 / 704 (0.14%)
Laryngitis † A 0 / 703 (0%)1 / 704 (0.14%)
Localised infection † A 1 / 703 (0.14%)0 / 704 (0%)
Lower respiratory tract infection † A 1 / 703 (0.14%)3 / 704 (0.43%)
Lung infection † A 3 / 703 (0.43%)6 / 704 (0.85%)
Measles † A 0 / 703 (0%)1 / 704 (0.14%)
Meningitis † A 0 / 703 (0%)1 / 704 (0.14%)
Meningitis cryptococcal † A 1 / 703 (0.14%)0 / 704 (0%)
Meningitis viral † A 0 / 703 (0%)1 / 704 (0.14%)
Nasopharyngitis † A 2 / 703 (0.28%)0 / 704 (0%)
Necrotising fasciitis † A 1 / 703 (0.14%)0 / 704 (0%)
Neutropenic infection † A 1 / 703 (0.14%)1 / 704 (0.14%)
Neutropenic sepsis † A 3 / 703 (0.43%)3 / 704 (0.43%)
Oral infection † A 2 / 703 (0.28%)0 / 704 (0%)
Orchitis † A 1 / 703 (0.14%)0 / 704 (0%)
Osteomyelitis † A 1 / 703 (0.14%)1 / 704 (0.14%)
Peritonitis † A 1 / 703 (0.14%)1 / 704 (0.14%)
Pharyngitis streptococcal † A 0 / 703 (0%)1 / 704 (0.14%)
Pneumocystis jirovecii pneumonia † A 3 / 703 (0.43%)1 / 704 (0.14%)
Pneumonia † A 32 / 703 (4.55%)40 / 704 (5.68%)
Pneumonia bacterial † A 0 / 703 (0%)1 / 704 (0.14%)
Progressive multifocal leukoencephalopathy † A 0 / 703 (0%)1 / 704 (0.14%)
Prostatic abscess † A 1 / 703 (0.14%)0 / 704 (0%)
Pseudomonal sepsis † A 1 / 703 (0.14%)0 / 704 (0%)
Pulmonary sepsis † A 1 / 703 (0.14%)0 / 704 (0%)
Rectal abscess † A 1 / 703 (0.14%)1 / 704 (0.14%)
Respiratory tract infection † A 0 / 703 (0%)2 / 704 (0.28%)
Scrotal abscess † A 1 / 703 (0.14%)0 / 704 (0%)
Sepsis † A 10 / 703 (1.42%)15 / 704 (2.13%)
Sepsis syndrome † A 0 / 703 (0%)1 / 704 (0.14%)
Septic shock † A 3 / 703 (0.43%)12 / 704 (1.7%)
Sinusitis fungal † A 0 / 703 (0%)1 / 704 (0.14%)
Soft tissue infection † A 1 / 703 (0.14%)0 / 704 (0%)
Subcutaneous abscess † A 0 / 703 (0%)1 / 704 (0.14%)
Tuberculosis † A 1 / 703 (0.14%)0 / 704 (0%)
Tuberculosis of central nervous system † A 1 / 703 (0.14%)0 / 704 (0%)
Upper respiratory tract infection † A 1 / 703 (0.14%)1 / 704 (0.14%)
Urinary tract infection † A 3 / 703 (0.43%)3 / 704 (0.43%)
Urosepsis † A 1 / 703 (0.14%)1 / 704 (0.14%)
Varicella † A 1 / 703 (0.14%)1 / 704 (0.14%)
Viral infection † A 0 / 703 (0%)1 / 704 (0.14%)
Viral pharyngitis † A 1 / 703 (0.14%)0 / 704 (0%)
Wound infection † A 0 / 703 (0%)1 / 704 (0.14%)
Injury, poisoning and procedural complications
Abdominal wound dehiscence † A 1 / 703 (0.14%)0 / 704 (0%)
Facial bones fracture † A 1 / 703 (0.14%)0 / 704 (0%)
Fall † A 0 / 703 (0%)1 / 704 (0.14%)
Femoral neck fracture † A 1 / 703 (0.14%)0 / 704 (0%)
Femur fracture † A 2 / 703 (0.28%)1 / 704 (0.14%)
Fracture † A 0 / 703 (0%)1 / 704 (0.14%)
Hip fracture † A 1 / 703 (0.14%)1 / 704 (0.14%)
Infusion related reaction † A 1 / 703 (0.14%)8 / 704 (1.14%)
Kidney rupture † A 1 / 703 (0.14%)0 / 704 (0%)
Lumbar vertebral fracture † A 1 / 703 (0.14%)0 / 704 (0%)
Nerve injury † A 0 / 703 (0%)1 / 704 (0.14%)
Pelvic fracture † A 0 / 703 (0%)1 / 704 (0.14%)
Postoperative respiratory failure † A 0 / 703 (0%)1 / 704 (0.14%)
Procedural complication † A 0 / 703 (0%)1 / 704 (0.14%)
Spinal compression fracture † A 1 / 703 (0.14%)0 / 704 (0%)
Subdural haematoma † A 0 / 703 (0%)3 / 704 (0.43%)
Toxicity to various agents † A 0 / 703 (0%)1 / 704 (0.14%)
Vascular pseudoaneurysm † A 1 / 703 (0.14%)0 / 704 (0%)
Wound haemorrhage † A 0 / 703 (0%)1 / 704 (0.14%)
Investigations
Ejection fraction decreased † A 0 / 703 (0%)1 / 704 (0.14%)
HIV antibody positive † A 0 / 703 (0%)1 / 704 (0.14%)
Oxygen saturation decreased † A 1 / 703 (0.14%)0 / 704 (0%)
Metabolism and nutrition disorders
Cachexia † A 0 / 703 (0%)1 / 704 (0.14%)
Decreased appetite † A 1 / 703 (0.14%)1 / 704 (0.14%)
Dehydration † A 4 / 703 (0.57%)5 / 704 (0.71%)
Diabetes mellitus † A 0 / 703 (0%)1 / 704 (0.14%)
Failure to thrive † A 3 / 703 (0.43%)0 / 704 (0%)
Hyperglycaemia † A 1 / 703 (0.14%)0 / 704 (0%)
Hyperkalaemia † A 0 / 703 (0%)1 / 704 (0.14%)
Hypokalaemia † A 2 / 703 (0.28%)2 / 704 (0.28%)
Hyponatraemia † A 2 / 703 (0.28%)0 / 704 (0%)
Hypophosphataemia † A 1 / 703 (0.14%)0 / 704 (0%)
Malnutrition † A 2 / 703 (0.28%)1 / 704 (0.14%)
Tumour lysis syndrome † A 2 / 703 (0.28%)1 / 704 (0.14%)
Musculoskeletal and connective tissue disorders
Arthralgia † A 2 / 703 (0.28%)1 / 704 (0.14%)
Back pain † A 1 / 703 (0.14%)2 / 704 (0.28%)
Costochondritis † A 1 / 703 (0.14%)0 / 704 (0%)
Intervertebral disc protrusion † A 0 / 703 (0%)1 / 704 (0.14%)
Joint swelling † A 1 / 703 (0.14%)0 / 704 (0%)
Myalgia † A 0 / 703 (0%)1 / 704 (0.14%)
Osteoarthritis † A 0 / 703 (0%)1 / 704 (0.14%)
Pain in extremity † A 1 / 703 (0.14%)0 / 704 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia † A 2 / 703 (0.28%)1 / 704 (0.14%)
Adenocarcinoma of colon † A 2 / 703 (0.28%)0 / 704 (0%)
B-cell lymphoma † A 1 / 703 (0.14%)0 / 704 (0%)
Breast cancer † A 2 / 703 (0.28%)1 / 704 (0.14%)
Colon adenoma † A 0 / 703 (0%)1 / 704 (0.14%)
Colon cancer † A 2 / 703 (0.28%)0 / 704 (0%)
Colorectal cancer † A 1 / 703 (0.14%)0 / 704 (0%)
Hepatic neoplasm † A 0 / 703 (0%)1 / 704 (0.14%)
Liposarcoma † A 0 / 703 (0%)1 / 704 (0.14%)
Lung adenocarcinoma † A 1 / 703 (0.14%)3 / 704 (0.43%)
Marginal zone lymphoma † A 1 / 703 (0.14%)0 / 704 (0%)
Neuroendocrine tumour † A 0 / 703 (0%)1 / 704 (0.14%)
Oesophageal carcinoma † A 1 / 703 (0.14%)0 / 704 (0%)
Papillary cystadenoma lymphomatosum † A 0 / 703 (0%)1 / 704 (0.14%)
Prostate cancer † A 2 / 703 (0.28%)2 / 704 (0.28%)
Small cell lung cancer metastatic † A 0 / 703 (0%)1 / 704 (0.14%)
Tumour perforation † A 0 / 703 (0%)1 / 704 (0.14%)
Nervous system disorders
Amyotrophic lateral sclerosis † A 0 / 703 (0%)1 / 704 (0.14%)
Cerebral haemorrhage † A 0 / 703 (0%)1 / 704 (0.14%)
Cerebral infarction † A 1 / 703 (0.14%)0 / 704 (0%)
Cerebral ischaemia † A 1 / 703 (0.14%)1 / 704 (0.14%)
Cerebrovascular accident † A 2 / 703 (0.28%)3 / 704 (0.43%)
Depressed level of consciousness † A 0 / 703 (0%)1 / 704 (0.14%)
Dizziness † A 0 / 703 (0%)2 / 704 (0.28%)
Embolic stroke † A 1 / 703 (0.14%)0 / 704 (0%)
Epilepsy † A 1 / 703 (0.14%)0 / 704 (0%)
Headache † A 2 / 703 (0.28%)3 / 704 (0.43%)
Hemiparesis † A 0 / 703 (0%)1 / 704 (0.14%)
Iiird nerve paralysis † A 0 / 703 (0%)1 / 704 (0.14%)
Ischaemic stroke † A 0 / 703 (0%)1 / 704 (0.14%)
Loss of consciousness † A 1 / 703 (0.14%)0 / 704 (0%)
Neuropathy peripheral † A 1 / 703 (0.14%)1 / 704 (0.14%)
Peripheral motor neuropathy † A 1 / 703 (0.14%)0 / 704 (0%)
Peripheral sensory neuropathy † A 1 / 703 (0.14%)0 / 704 (0%)
Polyneuropathy † A 1 / 703 (0.14%)0 / 704 (0%)
Presyncope † A 1 / 703 (0.14%)2 / 704 (0.28%)
Stroke in evolution † A 0 / 703 (0%)1 / 704 (0.14%)
Subarachnoid haemorrhage † A 0 / 703 (0%)1 / 704 (0.14%)
Syncope † A 3 / 703 (0.43%)0 / 704 (0%)
Toxic encephalopathy † A 1 / 703 (0.14%)0 / 704 (0%)
Transient ischaemic attack † A 1 / 703 (0.14%)0 / 704 (0%)
Vocal cord paralysis † A 1 / 703 (0.14%)0 / 704 (0%)
Psychiatric disorders
Anxiety † A 0 / 703 (0%)1 / 704 (0.14%)
Completed suicide † A 0 / 703 (0%)1 / 704 (0.14%)
Delirium † A 0 / 703 (0%)1 / 704 (0.14%)
Depression † A 1 / 703 (0.14%)0 / 704 (0%)
Emotional distress † A 0 / 703 (0%)1 / 704 (0.14%)
Mental status changes † A 0 / 703 (0%)1 / 704 (0.14%)
Renal and urinary disorders
Acute kidney injury † A 1 / 703 (0.14%)2 / 704 (0.28%)
Acute prerenal failure † A 1 / 703 (0.14%)0 / 704 (0%)
Cystitis glandularis † A 0 / 703 (0%)1 / 704 (0.14%)
Haematuria † A 0 / 703 (0%)2 / 704 (0.28%)
Renal colic † A 1 / 703 (0.14%)0 / 704 (0%)
Renal failure † A 1 / 703 (0.14%)1 / 704 (0.14%)
Renal impairment † A 0 / 703 (0%)1 / 704 (0.14%)
Urinary retention † A 0 / 703 (0%)1 / 704 (0.14%)
Reproductive system and breast disorders
Uterine haemorrhage † A 0 / 703 (0%)1 / 704 (0.14%)
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula † A 0 / 703 (0%)1 / 704 (0.14%)
Acute pulmonary oedema † A 0 / 703 (0%)1 / 704 (0.14%)
Acute respiratory distress syndrome † A 1 / 703 (0.14%)1 / 704 (0.14%)
Acute respiratory failure † A 3 / 703 (0.43%)1 / 704 (0.14%)
Alveolitis † A 0 / 703 (0%)1 / 704 (0.14%)
Asthma † A 0 / 703 (0%)1 / 704 (0.14%)
Bronchial obstruction † A 1 / 703 (0.14%)0 / 704 (0%)
Bronchospasm † A 1 / 703 (0.14%)1 / 704 (0.14%)
Chronic obstructive pulmonary disease † A 1 / 703 (0.14%)1 / 704 (0.14%)
Dyspnoea † A 1 / 703 (0.14%)2 / 704 (0.28%)
Dyspnoea exertional † A 0 / 703 (0%)1 / 704 (0.14%)
Emphysema † A 0 / 703 (0%)2 / 704 (0.28%)
Haemoptysis † A 0 / 703 (0%)1 / 704 (0.14%)
Haemothorax † A 0 / 703 (0%)1 / 704 (0.14%)
Hypoxia † A 1 / 703 (0.14%)1 / 704 (0.14%)
Interstitial lung disease † A 4 / 703 (0.57%)3 / 704 (0.43%)
Lung infiltration † A 0 / 703 (0%)1 / 704 (0.14%)
Organising pneumonia † A 1 / 703 (0.14%)0 / 704 (0%)
Pleural effusion † A 2 / 703 (0.28%)4 / 704 (0.57%)
Pneumonia aspiration † A 0 / 703 (0%)1 / 704 (0.14%)
Pneumonitis † A 1 / 703 (0.14%)5 / 704 (0.71%)
Pneumothorax † A 1 / 703 (0.14%)1 / 704 (0.14%)
Pulmonary embolism † A 4 / 703 (0.57%)4 / 704 (0.57%)
Pulmonary fibrosis † A 0 / 703 (0%)1 / 704 (0.14%)
Pulmonary oedema † A 0 / 703 (0%)1 / 704 (0.14%)
Respiratory disorder † A 0 / 703 (0%)1 / 704 (0.14%)
Respiratory failure † A 2 / 703 (0.28%)0 / 704 (0%)
Skin and subcutaneous tissue disorders
Diabetic foot † A 1 / 703 (0.14%)0 / 704 (0%)
Skin ulcer † A 1 / 703 (0.14%)2 / 704 (0.28%)
Vascular disorders
Deep vein thrombosis † A 0 / 703 (0%)2 / 704 (0.28%)
Haemorrhage † A 0 / 703 (0%)1 / 704 (0.14%)
Hypertension † A 0 / 703 (0%)1 / 704 (0.14%)
Hypotension † A 2 / 703 (0.28%)3 / 704 (0.43%)
Orthostatic hypotension † A 1 / 703 (0.14%)0 / 704 (0%)
Phlebitis † A 0 / 703 (0%)1 / 704 (0.14%)
Thrombophlebitis † A 2 / 703 (0.28%)0 / 704 (0%)
Thrombophlebitis superficial † A 0 / 703 (0%)1 / 704 (0.14%)
Venous occlusion † A 0 / 703 (0%)1 / 704 (0.14%)
Venous thrombosis † A 1 / 703 (0.14%)0 / 704 (0%)
Venous thrombosis limb † A 0 / 703 (0%)1 / 704 (0.14%)
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA, version 19.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
  Rituximab+ChemotherapyObinutuzumab+Chemotherapy
 Affected / At Risk (%)Affected / At Risk (%)
Total 604 / 703 (85.92%)642 / 704 (91.19%)
Blood and lymphatic system disorders
Anaemia † A 96 / 703 (13.66%)88 / 704 (12.5%)
Febrile neutropenia † A 44 / 703 (6.26%)52 / 704 (7.39%)
Leukopenia † A 84 / 703 (11.95%)109 / 704 (15.48%)
Neutropenia † A 261 / 703 (37.13%)304 / 704 (43.18%)
Thrombocytopenia † A 16 / 703 (2.28%)47 / 704 (6.68%)
Gastrointestinal disorders
Abdominal pain † A 46 / 703 (6.54%)47 / 704 (6.68%)
Abdominal pain upper † A 39 / 703 (5.55%)35 / 704 (4.97%)
Constipation † A 171 / 703 (24.32%)165 / 704 (23.44%)
Diarrhoea † A 89 / 703 (12.66%)110 / 704 (15.62%)
Dyspepsia † A 42 / 703 (5.97%)44 / 704 (6.25%)
Nausea † A 197 / 703 (28.02%)206 / 704 (29.26%)
Stomatitis † A 63 / 703 (8.96%)46 / 704 (6.53%)
Vomiting † A 72 / 703 (10.24%)102 / 704 (14.49%)
General disorders
Asthenia † A 73 / 703 (10.38%)71 / 704 (10.09%)
Chills † A 36 / 703 (5.12%)131 / 704 (18.61%)
Fatigue † A 120 / 703 (17.07%)133 / 704 (18.89%)
Mucosal inflammation † A 37 / 703 (5.26%)45 / 704 (6.39%)
Oedema peripheral † A 40 / 703 (5.69%)35 / 704 (4.97%)
Pyrexia † A 73 / 703 (10.38%)129 / 704 (18.32%)
Infections and infestations
Upper respiratory tract infection † A 46 / 703 (6.54%)43 / 704 (6.11%)
Injury, poisoning and procedural complications
Infusion related reaction † A 164 / 703 (23.33%)249 / 704 (35.37%)
Metabolism and nutrition disorders
Decreased appetite † A 70 / 703 (9.96%)96 / 704 (13.64%)
Hypokalaemia † A 49 / 703 (6.97%)60 / 704 (8.52%)
Musculoskeletal and connective tissue disorders
Back pain † A 42 / 703 (5.97%)57 / 704 (8.1%)
Nervous system disorders
Dizziness † A 27 / 703 (3.84%)47 / 704 (6.68%)
Dysgeusia † A 37 / 703 (5.26%)44 / 704 (6.25%)
Headache † A 56 / 703 (7.97%)73 / 704 (10.37%)
Neuropathy peripheral † A 88 / 703 (12.52%)87 / 704 (12.36%)
Paraesthesia † A 51 / 703 (7.25%)55 / 704 (7.81%)
Peripheral sensory neuropathy † A 56 / 703 (7.97%)54 / 704 (7.67%)
Psychiatric disorders
Insomnia † A 58 / 703 (8.25%)76 / 704 (10.8%)
Respiratory, thoracic and mediastinal disorders
Cough † A 60 / 703 (8.53%)83 / 704 (11.79%)
Dyspnoea † A 31 / 703 (4.41%)52 / 704 (7.39%)
Oropharyngeal pain † A 37 / 703 (5.26%)41 / 704 (5.82%)
Skin and subcutaneous tissue disorders
Alopecia † A 142 / 703 (20.2%)145 / 704 (20.6%)
Rash † A 45 / 703 (6.4%)16 / 704 (2.27%)
Vascular disorders
Hypertension † A 27 / 703 (3.84%)40 / 704 (5.68%)
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA, version 19.0
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact:
Name/Official Title:
 Medical Communications
Organization:
 Hoffmann-La Roche
Phone:
 800 821-8590
Email:
 genentech@druginfo.com
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