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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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)
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
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
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
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
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
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
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
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)
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)
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
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
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
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)
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2018
Sample size
Target
Accrual to date
Final
1418
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
State/province [39] 0 0
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
State/province [42] 0 0
Nanjing
Country [43] 0 0
China
State/province [43] 0 0
Nanning
Country [44] 0 0
China
State/province [44] 0 0
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
State/province [51] 0 0
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
State/province [56] 0 0
Roskilde
Country [57] 0 0
Denmark
State/province [57] 0 0
Århus
Country [58] 0 0
Germany
State/province [58] 0 0
Aachen
Country [59] 0 0
Germany
State/province [59] 0 0
Berlin
Country [60] 0 0
Germany
State/province [60] 0 0
Dresden
Country [61] 0 0
Germany
State/province [61] 0 0
Erlangen
Country [62] 0 0
Germany
State/province [62] 0 0
Gießen
Country [63] 0 0
Germany
State/province [63] 0 0
Heidelberg
Country [64] 0 0
Germany
State/province [64] 0 0
Würzburg
Country [65] 0 0
Hong Kong
State/province [65] 0 0
Hong Kong
Country [66] 0 0
Hungary
State/province [66] 0 0
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
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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
State/province [75] 0 0
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
State/province [81] 0 0
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
Country [85] 0 0
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
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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
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Gdansk
Country [111] 0 0
Poland
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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
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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
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Pontevedra
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Spain
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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 - ETS
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01287741