A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy

Status
Active
Cancer Type
Non-Hodgkin Lymphoma
Trial Phase
Phase II
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01414855
Protocol IDs
GAO4915g (primary)
BO25324
Study Sponsor
Genentech Incorporated

Summary

This open-label, multicenter study will evaluate the efficacy and safety of RO5072759 (GA101) in combination with CHOP chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of RO5072759 (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 RO5072759 will also be infused on Days 8 and 15) in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy during cycles 1 to 6.