85
Participants
Start Date
November 29, 2013
Primary Completion Date
December 19, 2018
Study Completion Date
December 19, 2018
Cyclophosphamide
Cyclophosphamide will be administered at 750 milligrams per square meter (mg/m\^2) IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
Doxorubicin
Doxorubicin will be administered at 50 mg/m\^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
Obinutuzumab
Obinutuzumab will be administered at 1000 milligrams (mg) IV on Cycle 1 Days 1, 8, and 15 and on Day 1 of Cycles 3-8.
Polatuzumab Vedotin
Polatuzumab vedotin will be administered at escalating doses (at a starting dose of 1 mg/kg) IV every 3 weeks, for 6 or 8 cycles.
Prednisolone
Prednisolone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles. Prednisone at 100 mg orally from Day -7 to Day -1 may be given at the discretion of the treating investigator physician.
Prednisone
Prednisone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles. Prednisone at 100 mg orally from Day -7 to Day -1 may be given at the discretion of the treating investigator physician.
Rituximab
Rituximab will be administered at 375 mg/m\^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
Blue Ridge Cancer Care, Roanoke
The University of Alabama at Birmingham, Birmingham
Hopital Claude Huriez - CHU Lille; Service des maladies du sang, Lille
Washington University; Pediatrics, St Louis
Centre Hospitalier Lyon Sud; Hematolgie, Pierre-Bénite
Centre Henri Becquerel; Hematologie, Rouen
Banner MD Anderson Cancer Center, Greeley
Hopital Henri Mondor, Unite Hemopathies lymphoides, Créteil
Northwest Cancer Specialists, Portland
Oregon Health and Science University, Portland
Willamette Valley Clinical Studies; Cancer Institute, Springfield
Lead Sponsor
Genentech, Inc.
INDUSTRY