NCT01118845

Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.

Detailed description

Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m\^2/day on day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.

Conditions

• Non-Hodgkin's Lymphoma
• Lymphoma, Large Cell
• Diffuse, Mantle Cell Lymphoma, Lymphoma
• Follicular Lymphoma
• Large B-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	SyB L-0501	The administration of SyB L-0501 at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. SyB L-0501 60 mg/m\^2, 90 mg/m\^2 or 120 mg/m\^2/day on Day 2 and Day 3 will be followed by 18 days of observation.
DRUG	Rituximab	The administration of rituximab at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-05-07
• Last updated: 2013-07-04
• Results posted: 2013-07-04

Locations

25 sites across 2 countries: Japan, South Korea