A Study of Obinutuzumab (RO5072759) in Combination With CHOP Chemotherapy Versus MabThera/Rituxan (Rituximab) With CHOP in Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Collaborator:
Fondazione Italiana Linfomi ONLUS
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01287741
First received: January 31, 2011
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with CHOP chemotherapy versus MabThera/Rituxan (rituximab) with CHOP in previously untreated patients with CD20-positive diffuse large B-cell lymphoma. Patients will be randomized to receive either obinutuzumab 1000 mg intravenously (iv) every 21 days or MabThera/Rituxan 375 mg/m2 iv every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days. Anticipated time on study treatment is 24 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, B-Cell |
Drug: RO5072759 Drug: rituximab [MabThera/Rituxan] Drug: CHOP chemotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicenter, Open-label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL) |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival, assessed by the investigator according to a modified version of the Revised Response Criteria for Malignant Lymphoma [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
- Overall response rate at the end of treatment, assessed by the investigator and the Independent Review Committee (IRC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Complete response rate at the end of treatment, assessed by investigator and IRC [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Progression-free survival assessed by the Independent Review Committee [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
- Event-free survival, defined as time to progression or relapse, or initiation of non-protocol-specified anti-lymphoma therapy, or death, whichever occurs first [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
- Disease-free survival, assessed by investigator [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
- Duration of response, assessed by the investigator [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
- Time to next lymphoma treatment [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
- Quality of life (Functional Assessment of Cancer Therapy-Lymphoma subscale, Euro-Quality of Life 5D questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Core 30) [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
- Medical resource utilization (hospitalizations, drug therapies, medical and surgical procedures and treatments) [ Time Frame: up to approximately 78 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: G-CHOP |
Drug: RO5072759
1000 mg iv every 21 days, 8 cycles (additional doses Days 8 and 15 of Cycle 1)
Other Name: GA101
Drug: CHOP chemotherapy
CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days, 6 or 8 cycles
|
| Active Comparator: R-CHOP |
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv every 21 days, 8 cycles
Drug: CHOP chemotherapy
CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv every 21 days, 6 or 8 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Low-intermediate, intermediate or high-risk IPI score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion >/= 7.5 cm)
Exclusion Criteria:
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
- Patients with transformed lymphoma and patients 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 (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
- Primary CNS lymphoma, blastic variant of mantle-cell lymphoma, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, and primary cutaneous DLBCL
- Positive for HIV
- Active hepatitis B or C infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287741
Show 234 Study Locations
Contacts
| Contact: Please reference Study ID Number: BO21005 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 234 Study LocationsSponsors and Collaborators
Hoffmann-La Roche
Fondazione Italiana Linfomi ONLUS
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01287741 History of Changes |
| Other Study ID Numbers: | BO21005, 2010-024194-39 |
| Study First Received: | January 31, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013