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 April 2014 by Hoffmann-La Roche
Sponsor:
Collaborator:
Fondazione Italiana Linfomi ONLUS
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01287741
First received: January 31, 2011
Last updated: April 22, 2014
Last verified: April 2014
  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: May 2016
Estimated Primary Completion Date: August 2015 (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)
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

Contacts
Contact: Reference Study ID Number: BO21005 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 244 Study Locations
Sponsors 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: April 22, 2014
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 April 23, 2014