drugset / Trial / NCT00069758

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

NCT00069758 ↗

Phase 2 Completed 72 enrolled Cephalon
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2003-09
Primary completion
2007-04
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule — Intravenous

Indications