A Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy Versus MabThera/Rituxan (Rituximab) With CHOP in Patients With CD20-Positive Diffuse Large B-Cell Lymphoma

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) - GOYA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024194-39-GB

Enrollment

1400

Registered

2011-03-10

Start date

2011-08-02

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PREVIOUSLY UNTREATED PATIENTS WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) MedDRA version: 20.0 Level: HLT Classification code 10012819 Term: Diffuse large B-cell lymphomas System Organ Class: 100000004943 MedDRA version: 20.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10

Interventions

Product Name: Obinutuzumab (GA101) Product Code: RO5072759 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Obinutuzumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients, >/= 18 years of age Previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) At least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the CT scan) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Adequate hematological function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 700

Exclusion criteria

Exclusion criteria: History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or any component of CHOP or GA101 Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines Diagnosis of transformed lymphoma (follicular IIIB) if previously treated with radiotherapy, chemotherapy, or immunotherapy Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation Prior treatment with cytotoxic drugs or rituximab for another condition (e.g., 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 Ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent, for purposes other then lymphoma symptom control Primary CNS lymphoma and secondary CNS invilvement by lymphoma, MCL, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL Patients with a history of confirmed PML

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: up to approximately 78 months; Main Objective: The primary objective of this study is to demonstrate superiority in PFS with G-CHOP compared with rituximab plus chemotherapy (R-CHOP) in previously untreated patients with CD20-positive DLBCL, based on investigator-assessed PFS. ; Secondary Objective: OS up to approximately 78 months ORR at the end of treatment, assessed by the investigator and the IRC 24 weeks CR rate at the end of treatment, assessed by investigator and IRC 24 weeks EFS, defined as time to progression or relapse, or initiation of nonprotocol- specified anti-lymphoma therapy, or death, whichever occurs first up to approximately 78 months PFS assessed by the Independent Review Committee up to Event-free survival, defined as time to progression or relapse, or initiation of nonprotocol- specified anti-lymphoma therapy, or death, whichever occurs first Disease-free survival, assessed by investigator up to approximately 78 months Duration of response, assessed by the investigator up to approximately 78 months Time to next lymphoma treatment up to approximately 78 months Incidence of adverse events up to approximately 78 months Quality of life up to approximately 78 months Medical resource utilization up to approximately 78 months ; Primary end point(s): The primary efficacy endpoint is PFS, as determined by the investigator, defined as the time from the date of randomization until the first occurrence of disease progression, relapse, or death from any cause. While the primary efficacy endpoint is investigator-assessed PFS, PFS based on IRC assessments will also be analyzed to support the primary analysis. In the United States, IRC-ass	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: up to approximately 78 months; Main Objective: The primary objective of this study is to demonstrate superiority in PFS with G-CHOP compared with rituximab plus chemotherapy (R-CHOP) in previously untreated patients with CD20-positive DLBCL, based on investigator-assessed PFS. ; Secondary Objective: OS up to approximately 78 months ORR at the end of treatment, assessed by the investigator and the IRC 24 weeks CR rate at the end of treatment, assessed by investigator and IRC 24 weeks EFS, defined as time to progression or relapse, or initiation of nonprotocol- specified anti-lymphoma therapy, or death, whichever occurs first up to approximately 78 months PFS assessed by the Independent Review Committee up to Event-free survival, defined as time to progression or relapse, or initiation of nonprotocol- specified anti-lymphoma therapy, or death, whichever occurs first Disease-free survival, assessed by investigator up to approximately 78 months Duration of response, assessed by the investigator up to approximately 78 months Time to next lymphoma treatment up to approximately 78 months Incidence of adverse events up to approximately 78 months Quality of life up to approximately 78 months Medical resource utilization up to approximately 78 months ; Primary end point(s): The primary efficacy endpoint is PFS, as determined by the investigator, defined as the time from the date of randomization until the first occurrence of disease progression, relapse, or death from any cause. While the primary efficacy endpoint is investigator-assessed PFS, PFS based on IRC assessments will also be analyzed to support the primary analysis. In the United States, IRC-ass

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Secondary

Measure	Time frame
Secondary end point(s): - ORR at the end of treatment, assessed by the investigator and IRC - CR rate at the end of treatment, assessed by investigator and IRC - PFS assessed by the IRC - Event-free survival, defined as time to progression or relapse, or initiation of non-protocol-specified anti-lymphoma therapy, or death, whichever occurs first - Disease-free survival, assessed by investigator - Duration of response, assessed by the investigator - Time to next lymphoma treatment - Incidence of adverse events - Quality of life - Medical resource utilization ; Timepoint(s) of evaluation of this end point: 24 months for PFS, OS, ORR, CRR up to approximately 78 months for all other measures	—

Measure

Time frame

Secondary end point(s): - ORR at the end of treatment, assessed by the investigator and IRC - CR rate at the end of treatment, assessed by investigator and IRC - PFS assessed by the IRC - Event-free survival, defined as time to progression or relapse, or initiation of non-protocol-specified anti-lymphoma therapy, or death, whichever occurs first - Disease-free survival, assessed by investigator - Duration of response, assessed by the investigator - Time to next lymphoma treatment - Incidence of adverse events - Quality of life - Medical resource utilization ; Timepoint(s) of evaluation of this end point: 24 months for PFS, OS, ORR, CRR up to approximately 78 months for all other measures

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Countries

Australia, Austria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Japan, Korea, Democratic People's Republic of, Poland, Slovakia, Spain, Thailand, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026