A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Rituximab; Obinutuzumab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone
Intervention description: Rituximab at a dose of 375 mg/m^2, administered by intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles.; Obinutuzumab 1000 mg IV infusion, administered on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, obinutuzumab was also infused on Days 8 and 15.; Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.; Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.; Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.; Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Obinutuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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