NCT01570049

Safety and Efficacy Study of Bendamustine to Treat Non-Hodgkin Lymphoma

A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether bendamustine HCl for injection is safe and effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.

Detailed description

This is multicenter, open label study to evaluate the safety and efficacy of bendamustine HCl in patients with indolent Non-hodgkin's lymphoma and relapsed after rituximab treatment. This injection will be given through i.v. infusion in \>= 60 minutes on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for up to 8 cycles unless progressive disease or unacceptable toxicity take place. Patients will be followed for up to 1 year before evaluating progression free survival (PFS) and overall survival (OS).

Conditions

• Non-Hodgkin Lymphoma by Clinical Course

Interventions

Type	Name	Description
DRUG	Bendamustine	for injection

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2012-04-04
• Last updated: 2012-08-02

Locations

2 sites across 1 country: China