A study for patients with Non-Hodgkin's Lymphoma (GOYA)

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

  • Non-Hodgkin's Lymphoma
Trial Status:

Completed

This trial runs in
Countries
  • Switzerland
Trial Identifier:

NCT01287741 2010-024194-39 (EudraCT number)

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      F. Hoffmann-La Roche Ltd Sponsor
      Phase 3 Phase
      NCT01287741 , 2010-024194-39 (EudraCT number) Trial Identifier
      Rituximab, Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Treatments
      NHL Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      18 Years and over 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

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