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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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)
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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)
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Secondary ID [1]
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2010-024194-39
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Secondary ID [2]
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BO21005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Median Time to Progression-Free Survival (PFS), Investigator-Assessed
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline up to approximately 6.5 years (up to 31 January 2018)
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Secondary outcome [1]
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Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
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Secondary outcome [2]
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Median Time to Overall Survival (OS)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to approximately 6.5 years (up to 31 January 2018)
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Secondary outcome [3]
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Overall Response Rate (ORR), Investigator-Assessed
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline up to approximately 6.5 years (up to 31 January 2018)
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Secondary outcome [4]
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Overall Response Rate (ORR), IRC-Assessed
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
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Secondary outcome [5]
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Complete Response (CR) at the End of Treatment, Investigator-Assessed
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline up to approximately 6.5 years (up to 31 January 2018)
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Secondary outcome [6]
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Complete Response (CR) at the End of Treatment, IRC-Assessed
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
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Secondary outcome [7]
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Median Time to Event-Free Survival (EFS), Investigator-Assessed
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Assessment method [7]
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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.
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Timepoint [7]
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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)
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Secondary outcome [8]
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Median Time to Disease-Free Survival (DFS), Investigator-Assessed
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
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Secondary outcome [9]
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Duration of Response (DOR), Investigator-Assessed
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Assessment method [9]
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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%.
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Timepoint [9]
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Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
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Secondary outcome [10]
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Time to Next Anti-Lymphoma Treatment (TTNALT)
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Assessment method [10]
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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.
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Timepoint [10]
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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)
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Secondary outcome [11]
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Percentage of Participants With Adverse Events (AEs)
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline up to approximately 6.5 years (up to 31 January 2018)
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Secondary outcome [12]
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Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
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Assessment method [12]
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The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.
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Timepoint [12]
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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)
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Secondary outcome [13]
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Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
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Assessment method [13]
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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.
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Timepoint [13]
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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)
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Secondary outcome [14]
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
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Assessment method [14]
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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.
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Timepoint [14]
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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)
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Secondary outcome [15]
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Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
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Assessment method [15]
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Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.
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Timepoint [15]
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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)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/07/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/01/2018
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Sample size
Target
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Accrual to date
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Final
1418
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Cairns Base Hospital; Cancer Care Centre - Cairns
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Recruitment hospital [2]
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Frankston Hospital; Oncology/Haematology - Frankston
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Recruitment hospital [3]
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Monash Medical Centre; Haematology - Melbourne
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Recruitment hospital [4]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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4870 - Cairns
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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3168 - Melbourne
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Florida
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Georgia
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Illinois
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Maine
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Minnesota
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New York
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North Carolina
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Ohio
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Oregon
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Argentina
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Cordoba
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Argentina
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Rosario
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Austria
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Innsbruck
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Austria
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Salzburg
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Austria
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Wien
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Brazil
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RS
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Brazil
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SC
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Brazil
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SP
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Canada
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Saskatchewan
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China
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Beijing
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China
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Changchun
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China
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Changsha
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China
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Fujian
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China
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Fuzhou
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China
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Guangzhou
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China
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Hangzhou
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China
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Harbin
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China
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Nanchang
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China
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Nanjing
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China
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Nanning
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China
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Shanghai
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China
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Shenyang
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China
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Suzhou
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China
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Tianjin
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China
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Wuhan
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China
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Xi'an
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Colombia
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Bogota
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Colombia
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Floridablanca
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha 2
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Denmark
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København Ø
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Denmark
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Roskilde
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Country [57]
0
0
Denmark
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State/province [57]
0
0
Århus
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0
0
Germany
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Aachen
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Country [59]
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Germany
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Berlin
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Country [60]
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Germany
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Dresden
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Country [61]
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0
Germany
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0
Erlangen
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Country [62]
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0
Germany
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Gießen
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Country [63]
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Germany
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Heidelberg
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Country [64]
0
0
Germany
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Würzburg
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Country [65]
0
0
Hong Kong
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Hong Kong
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Country [66]
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Hungary
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Budapest
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Country [67]
0
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Hungary
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State/province [67]
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0
Debrecen
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Country [68]
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0
Hungary
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State/province [68]
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0
Gyor
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Country [69]
0
0
Hungary
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State/province [69]
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0
Kaposvar
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Country [70]
0
0
Hungary
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State/province [70]
0
0
Pecs
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Country [71]
0
0
Hungary
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State/province [71]
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0
Szeged
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Country [72]
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Italy
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State/province [72]
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Calabria
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Country [73]
0
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Italy
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Campania
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Country [74]
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Italy
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Emilia-Romagna
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Country [75]
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Italy
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Friuli-Venezia Giulia
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Country [76]
0
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Italy
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Lazio
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Country [77]
0
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Italy
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State/province [77]
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Liguria
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Country [78]
0
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Italy
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State/province [78]
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Lombardia
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Country [79]
0
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Italy
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State/province [79]
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Piemonte
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Country [80]
0
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Italy
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State/province [80]
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Puglia
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Country [81]
0
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Italy
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State/province [81]
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Sicilia
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Country [82]
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Italy
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State/province [82]
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Toscana
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Country [83]
0
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Italy
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Umbria
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Country [84]
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Italy
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Veneto
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Country [85]
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Japan
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State/province [85]
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Aichi
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Country [86]
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Japan
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State/province [86]
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Chiba
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Country [87]
0
0
Japan
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State/province [87]
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0
Fukuoka
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Country [88]
0
0
Japan
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State/province [88]
0
0
Gifu
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Country [89]
0
0
Japan
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State/province [89]
0
0
Hokkaido
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Country [90]
0
0
Japan
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State/province [90]
0
0
Hyogo
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Country [91]
0
0
Japan
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State/province [91]
0
0
Iwate
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Country [92]
0
0
Japan
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State/province [92]
0
0
Kanagawa
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Country [93]
0
0
Japan
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State/province [93]
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0
Kyoto
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Country [94]
0
0
Japan
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State/province [94]
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0
Niigata
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Country [95]
0
0
Japan
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State/province [95]
0
0
Okayama
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Country [96]
0
0
Japan
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State/province [96]
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Osaka
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Country [97]
0
0
Japan
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State/province [97]
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0
Shimane
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Country [98]
0
0
Japan
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State/province [98]
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0
Tochigi
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Country [99]
0
0
Japan
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State/province [99]
0
0
Tokyo
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Country [100]
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0
Korea, Republic of
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State/province [100]
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Gyeonggi-do
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Country [101]
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0
Korea, Republic of
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State/province [101]
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Jeollanam-do
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Country [102]
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Korea, Republic of
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Seoul
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Country [103]
0
0
Mexico
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State/province [103]
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Chihuahua
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Country [104]
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Mexico
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Monterrey
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Country [105]
0
0
Mexico
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Oaxaca
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Country [106]
0
0
Mexico
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State/province [106]
0
0
Queretaro
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Country [107]
0
0
Panama
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State/province [107]
0
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Panama
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Country [108]
0
0
Peru
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State/province [108]
0
0
Lima
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Country [109]
0
0
Poland
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State/province [109]
0
0
Brzozów
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Country [110]
0
0
Poland
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State/province [110]
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0
Gdansk
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Country [111]
0
0
Poland
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State/province [111]
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0
Lodz
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Country [112]
0
0
Poland
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State/province [112]
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Lublin
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Country [113]
0
0
Poland
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State/province [113]
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Warszawa
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Country [114]
0
0
Poland
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State/province [114]
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0
Wroclaw
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Country [115]
0
0
Russian Federation
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State/province [115]
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Kazan
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Country [116]
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0
Russian Federation
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State/province [116]
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0
Moscow
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Country [117]
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0
Russian Federation
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State/province [117]
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0
Nizhny Novgorod
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Country [118]
0
0
Russian Federation
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State/province [118]
0
0
Penza
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Country [119]
0
0
Russian Federation
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State/province [119]
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0
Petrozavodsk
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Country [120]
0
0
Russian Federation
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State/province [120]
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0
St Petersburg
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Country [121]
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0
Serbia
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State/province [121]
0
0
Belgrade
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Country [122]
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0
Serbia
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State/province [122]
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0
Novi Sad
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Country [123]
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0
Slovakia
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State/province [123]
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0
Bratislava
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Country [124]
0
0
South Africa
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State/province [124]
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0
Cape Town
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Country [125]
0
0
South Africa
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State/province [125]
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0
Groenkloof
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Country [126]
0
0
South Africa
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State/province [126]
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0
Johannesburg
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Country [127]
0
0
South Africa
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State/province [127]
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Parktown, Johannesburg
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Country [128]
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0
South Africa
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State/province [128]
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Pretoria
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Country [129]
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0
Spain
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State/province [129]
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Navarra
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Country [130]
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Spain
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Tarragona
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Country [131]
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Spain
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Barcelona
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Country [132]
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Spain
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Madrid
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Country [133]
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Spain
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State/province [133]
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Pontevedra
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Country [134]
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Spain
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State/province [134]
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Sevilla
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Country [135]
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Spain
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State/province [135]
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Toledo
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Country [136]
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0
Switzerland
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State/province [136]
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Aarau
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Country [137]
0
0
Switzerland
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State/province [137]
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Bellinzona
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Country [138]
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Switzerland
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Chur
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Country [139]
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Switzerland
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Zürich
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Country [140]
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Taiwan
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Taipei
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Country [141]
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0
Taiwan
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State/province [141]
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Taoyuan
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Country [142]
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0
Thailand
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State/province [142]
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0
Bangkok
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Country [143]
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0
Thailand
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State/province [143]
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0
Khon Kaen
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Country [144]
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0
United Kingdom
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State/province [144]
0
0
Aberdeen
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Country [145]
0
0
United Kingdom
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0
0
Birmingham
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Country [146]
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0
United Kingdom
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Cambridge
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Country [147]
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United Kingdom
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Leicester
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Country [148]
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0
United Kingdom
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State/province [148]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
Fondazione Italiana Linfomi - ETS
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01287741
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Trials
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Address
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0
Hoffmann-La Roche
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0
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Phone
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0
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01287741
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