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

NCT00069758 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-05-09

No results posted yet for this study

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

DRUG

SDX-105

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00069758 on ClinicalTrials.gov