Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
Low-grade B Cell Non-Hodgkin's LymphomaMantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated
Interventions
DRUG

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.

DRUG

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.

Trial Locations (14)

Unknown

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

Sponsors
All Listed Sponsors
lead

SymBio Pharmaceuticals

INDUSTRY

NCT01718691 - Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter