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. (see Contacts and Locations)
Verified July 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: July 21, 2014
Last verified: July 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 CD 20-positive diffuse large B-cell lymphoma. Patients will be randomized to receiv e either obinutuzumab 1000 mg intravenously (iv) every 21 days or MabThera/Ritux an 375 mg/m2 iv every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP ch emotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone) iv ever y 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 231 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: July 21, 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 July 23, 2014