A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

  • Cancer
  • Non Hodgkin Lymphoma (NHL)
  • Diffuse Large B-Cell Lymphoma (DLBCL)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Terminated

This study runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • China
  • Colombia
  • Czechia
  • Denmark
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Panama
  • Peru
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom
  • United States
Study Identifier:

NCT01287741 2010-024194-39 BO21005

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT01287741, BO21005, 2010-024194-39 Study Identifier
      Rituximab, Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Treatments
      Diffuse Large B-Cell Lymphoma Condition
      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)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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