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

Phase II Clinical 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 (Multicenter, Open-label).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma where hematopoietic stem cell transplantation is not indicated.

Conditions

• Low-grade B Cell Non-Hodgkin's Lymphoma
• Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-10-31
• Last updated: 2016-04-27
• Results posted: 2016-04-27

Locations

14 sites across 1 country: Japan