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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01287741




Registration number
NCT01287741
Ethics application status
Date submitted
31/01/2011
Date registered
1/02/2011
Date last updated
12/04/2019

Titles & IDs
Public 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)
Scientific 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 ID [1] 0 0
2010-024194-39
Secondary ID [2] 0 0
BO21005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rituximab
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone

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.

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.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.

Treatment: Drugs: Doxorubicin
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.

Treatment: Drugs: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.

Treatment: Drugs: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Median Time to Progression-Free Survival (PFS), Investigator-Assessed - Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
Timepoint [1] 0 0
Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary outcome [1] 0 0
Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed - Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease [PD]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants.
Timepoint [1] 0 0
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Secondary outcome [2] 0 0
Median Time to Overall Survival (OS) - Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause.
Timepoint [2] 0 0
Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary outcome [3] 0 0
Overall Response Rate (ORR), Investigator-Assessed - 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.
Timepoint [3] 0 0
Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary outcome [4] 0 0
Overall Response Rate (ORR), IRC-Assessed - Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants.
Timepoint [4] 0 0
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Secondary outcome [5] 0 0
Complete Response (CR) at the End of Treatment, Investigator-Assessed - 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.
Timepoint [5] 0 0
Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary outcome [6] 0 0
Complete Response (CR) at the End of Treatment, IRC-Assessed - Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants.
Timepoint [6] 0 0
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Secondary outcome [7] 0 0
Median Time to Event-Free Survival (EFS), Investigator-Assessed - Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.
Timepoint [7] 0 0
Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Secondary outcome [8] 0 0
Median Time to Disease-Free Survival (DFS), Investigator-Assessed - Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.
Timepoint [8] 0 0
Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Secondary outcome [9] 0 0
Duration of Response (DOR), Investigator-Assessed - 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%.
Timepoint [9] 0 0
Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Secondary outcome [10] 0 0
Time to Next Anti-Lymphoma Treatment (TTNALT) - 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.
Timepoint [10] 0 0
Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)
Secondary outcome [11] 0 0
Percentage of Participants With Adverse Events (AEs) - 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.
Timepoint [11] 0 0
Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary outcome [12] 0 0
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab - The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.
Timepoint [12] 0 0
Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)
Secondary outcome [13] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score - The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.
Timepoint [13] 0 0
Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
Secondary outcome [14] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores - 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.
Timepoint [14] 0 0
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 6.5 years, (cycle length = 21 days)
Secondary outcome [15] 0 0
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL) - Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.
Timepoint [15] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Cairns Base Hospital; Cancer Care Centre - Cairns
Recruitment hospital [2] 0 0
Frankston Hospital; Oncology/Haematology - Frankston
Recruitment hospital [3] 0 0
Monash Medical Centre; Haematology - Melbourne
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3168 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Argentina
State/province [19] 0 0
Cordoba
Country [20] 0 0
Argentina
State/province [20] 0 0
Rosario
Country [21] 0 0
Austria
State/province [21] 0 0
Innsbruck
Country [22] 0 0
Austria
State/province [22] 0 0
Salzburg
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Brazil
State/province [24] 0 0
RS
Country [25] 0 0
Brazil
State/province [25] 0 0
SC
Country [26] 0 0
Brazil
State/province [26] 0 0
SP
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Nova Scotia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Canada
State/province [32] 0 0
Saskatchewan
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Changchun
Country [35] 0 0
China
State/province [35] 0 0
Changsha
Country [36] 0 0
China
State/province [36] 0 0
Fujian
Country [37] 0 0
China
State/province [37] 0 0
Fuzhou
Country [38] 0 0
China
State/province [38] 0 0
Guangzhou
Country [39] 0 0
China
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Hangzhou
Country [40] 0 0
China
State/province [40] 0 0
Harbin
Country [41] 0 0
China
State/province [41] 0 0
Nanchang
Country [42] 0 0
China
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Nanjing
Country [43] 0 0
China
State/province [43] 0 0
Nanning
Country [44] 0 0
China
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Shanghai
Country [45] 0 0
China
State/province [45] 0 0
Shenyang
Country [46] 0 0
China
State/province [46] 0 0
Suzhou
Country [47] 0 0
China
State/province [47] 0 0
Tianjin
Country [48] 0 0
China
State/province [48] 0 0
Wuhan
Country [49] 0 0
China
State/province [49] 0 0
Xi'an
Country [50] 0 0
Colombia
State/province [50] 0 0
Bogota
Country [51] 0 0
Colombia
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Floridablanca
Country [52] 0 0
Czechia
State/province [52] 0 0
Brno
Country [53] 0 0
Czechia
State/province [53] 0 0
Hradec Kralove
Country [54] 0 0
Czechia
State/province [54] 0 0
Praha 2
Country [55] 0 0
Denmark
State/province [55] 0 0
København Ø
Country [56] 0 0
Denmark
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Roskilde
Country [57] 0 0
Denmark
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Århus
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Gießen
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Germany
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Heidelberg
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Germany
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Würzburg
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Hong Kong
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Hong Kong
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Hungary
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Budapest
Country [67] 0 0
Hungary
State/province [67] 0 0
Debrecen
Country [68] 0 0
Hungary
State/province [68] 0 0
Gyor
Country [69] 0 0
Hungary
State/province [69] 0 0
Kaposvar
Country [70] 0 0
Hungary
State/province [70] 0 0
Pecs
Country [71] 0 0
Hungary
State/province [71] 0 0
Szeged
Country [72] 0 0
Italy
State/province [72] 0 0
Calabria
Country [73] 0 0
Italy
State/province [73] 0 0
Campania
Country [74] 0 0
Italy
State/province [74] 0 0
Emilia-Romagna
Country [75] 0 0
Italy
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Friuli-Venezia Giulia
Country [76] 0 0
Italy
State/province [76] 0 0
Lazio
Country [77] 0 0
Italy
State/province [77] 0 0
Liguria
Country [78] 0 0
Italy
State/province [78] 0 0
Lombardia
Country [79] 0 0
Italy
State/province [79] 0 0
Piemonte
Country [80] 0 0
Italy
State/province [80] 0 0
Puglia
Country [81] 0 0
Italy
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Sicilia
Country [82] 0 0
Italy
State/province [82] 0 0
Toscana
Country [83] 0 0
Italy
State/province [83] 0 0
Umbria
Country [84] 0 0
Italy
State/province [84] 0 0
Veneto
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Japan
State/province [85] 0 0
Aichi
Country [86] 0 0
Japan
State/province [86] 0 0
Chiba
Country [87] 0 0
Japan
State/province [87] 0 0
Fukuoka
Country [88] 0 0
Japan
State/province [88] 0 0
Gifu
Country [89] 0 0
Japan
State/province [89] 0 0
Hokkaido
Country [90] 0 0
Japan
State/province [90] 0 0
Hyogo
Country [91] 0 0
Japan
State/province [91] 0 0
Iwate
Country [92] 0 0
Japan
State/province [92] 0 0
Kanagawa
Country [93] 0 0
Japan
State/province [93] 0 0
Kyoto
Country [94] 0 0
Japan
State/province [94] 0 0
Niigata
Country [95] 0 0
Japan
State/province [95] 0 0
Okayama
Country [96] 0 0
Japan
State/province [96] 0 0
Osaka
Country [97] 0 0
Japan
State/province [97] 0 0
Shimane
Country [98] 0 0
Japan
State/province [98] 0 0
Tochigi
Country [99] 0 0
Japan
State/province [99] 0 0
Tokyo
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Gyeonggi-do
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Jeollanam-do
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Seoul
Country [103] 0 0
Mexico
State/province [103] 0 0
Chihuahua
Country [104] 0 0
Mexico
State/province [104] 0 0
Monterrey
Country [105] 0 0
Mexico
State/province [105] 0 0
Oaxaca
Country [106] 0 0
Mexico
State/province [106] 0 0
Queretaro
Country [107] 0 0
Panama
State/province [107] 0 0
Panama
Country [108] 0 0
Peru
State/province [108] 0 0
Lima
Country [109] 0 0
Poland
State/province [109] 0 0
Brzozów
Country [110] 0 0
Poland
State/province [110] 0 0
Gdansk
Country [111] 0 0
Poland
State/province [111] 0 0
Lodz
Country [112] 0 0
Poland
State/province [112] 0 0
Lublin
Country [113] 0 0
Poland
State/province [113] 0 0
Warszawa
Country [114] 0 0
Poland
State/province [114] 0 0
Wroclaw
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Kazan
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Moscow
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Nizhny Novgorod
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Penza
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Petrozavodsk
Country [120] 0 0
Russian Federation
State/province [120] 0 0
St Petersburg
Country [121] 0 0
Serbia
State/province [121] 0 0
Belgrade
Country [122] 0 0
Serbia
State/province [122] 0 0
Novi Sad
Country [123] 0 0
Slovakia
State/province [123] 0 0
Bratislava
Country [124] 0 0
South Africa
State/province [124] 0 0
Cape Town
Country [125] 0 0
South Africa
State/province [125] 0 0
Groenkloof
Country [126] 0 0
South Africa
State/province [126] 0 0
Johannesburg
Country [127] 0 0
South Africa
State/province [127] 0 0
Parktown, Johannesburg
Country [128] 0 0
South Africa
State/province [128] 0 0
Pretoria
Country [129] 0 0
Spain
State/province [129] 0 0
Navarra
Country [130] 0 0
Spain
State/province [130] 0 0
Tarragona
Country [131] 0 0
Spain
State/province [131] 0 0
Barcelona
Country [132] 0 0
Spain
State/province [132] 0 0
Madrid
Country [133] 0 0
Spain
State/province [133] 0 0
Pontevedra
Country [134] 0 0
Spain
State/province [134] 0 0
Sevilla
Country [135] 0 0
Spain
State/province [135] 0 0
Toledo
Country [136] 0 0
Switzerland
State/province [136] 0 0
Aarau
Country [137] 0 0
Switzerland
State/province [137] 0 0
Bellinzona
Country [138] 0 0
Switzerland
State/province [138] 0 0
Chur
Country [139] 0 0
Switzerland
State/province [139] 0 0
Zürich
Country [140] 0 0
Taiwan
State/province [140] 0 0
Taipei
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taoyuan
Country [142] 0 0
Thailand
State/province [142] 0 0
Bangkok
Country [143] 0 0
Thailand
State/province [143] 0 0
Khon Kaen
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Aberdeen
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Birmingham
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Cambridge
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Leicester
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Fondazione Italiana Linfomi ONLUS
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01287741
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01287741