NCT00794638

A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma

A Multicenter Phase I Clinical Trial to Assess the Safety of Two Consecutive Days of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: SymBio Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial.

Conditions

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

Interventions

Type	Name	Description
DRUG	SyB L-0501	The administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
DRUG	Rituximab	The administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2008-11-20
• Last updated: 2021-07-02

Locations

4 sites across 1 country: Japan