drugset / Trial / 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

NCT01718691 ↗

Phase 2 Completed 70 enrolled SymBio Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-11
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous