70
Participants
Start Date
November 30, 2011
Primary Completion Date
November 30, 2013
Study Completion Date
November 30, 2013
SyB L-0501
A dose of 90 mg/m\^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.
rituximab
A dose of 375 mg/m\^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.
Research site, Nagoya
Research site, Kashiwa
Research site, Fukuoka
Research site, Sapporo
Research site, Kagoshima
Research site, Isehara
Research site, Kyoto
Research site, Sendai
Research site, Nagasaki
Research site, Moriguchi
Research site, Izumo
Research site, Hamamatsu
Research site, Utsunomiya
Research site, Tokyo
Lead Sponsor
SymBio Pharmaceuticals
INDUSTRY