NCT00069758

Safety and Activity of SDX-105 (Bendamustine) in Patients With Rituximab Refractory Non-Hodgkin's Lymphoma

A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (planned)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Summary: As this is an open label study, all patients will receive SDX-105 by 30-60 minute intravenous infusion on day 1 and day 2. Treatment will repeat every 21 days. Treatment can continue for up to one year in the absence of disease progression or unacceptable toxicity. Patients will be followed until disease progression. Rationale: Drugs used in chemotherapy, such as SDX-105, use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: This study will evaluate the effectiveness and safety in non-Hodgkin's lymphoma in patients who are refractory to Rituxan.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	SDX-105

Timeline

• Start date: 2003-09-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2003-10-02
• Last updated: 2014-05-09

Locations

17 sites across 2 countries: United States, Canada