Conditions: Lymphoma, B-Cell
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 100
Healthy volunteers: no

Brief summary:
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.

Detailed description:

Arms:
arm 1: Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.

Interventions: intervention 1: obinutuzumab intervention 2: cyclophosphamide intervention 3: doxorubicin intervention 4: prednisone intervention 5: vincristine
Intervention descriptions: intervention 1: 1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15. intervention 2: 750 mg/m\^2 intravenous (IV), Day 1 of each 21-day cycle, 6 cycles. intervention 3: 50 mg/m\^2 IV, Day 1 of each 21-cycle, 6 cycles. intervention 4: 100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles. intervention 5: 1.4 mg/m\^2 IV, Day 1 of each 21-day cycle, 6 cycles.

Protocol document: