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

Completed · Phase 2

Conditions studied: Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00069758

Run by

Cephalon

People needed

72

Starts

2003-09-01

Expected to finish

2007-04-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented indolent or transformed B-Cell NHL indolent NHL: follicular B-Cell lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma
• Documented refractory disease to rituximab therapy, given as a single agent or in combination (defined as no response, or progression within 6 months of completing rituximab treatment.)
• Age of at least 18 years at Screening Visit (Site specific requirement may differ)

You may not qualify if…

• Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously.
• Use of investigational agents within 28 days of study
• History of prior high dose chemotherapy with allogeneic stem cell support

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Comprehensive Cancer Center-Desert Regional Medical Center — Palm Springs, California, United States
• San Diego Cancer Center — Vista, California, United States
• Georgetown University Medical Center - Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Mountain States Tumor Institute — Boise, Idaho, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• The Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• University of Rochester Medical Center — Rochester, New York, United States
• The Sarah Cannon Cancer Center — Nashville, Tennessee, United States
• Southwest Regional Cancer Center — Austin, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• Queen Elizabeth Health Sciences Centre — Halifax, Nova Scotia, Canada
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada
• Toronto Sunnybrook Regional Cancer Centre — Toronto, Ontario, Canada
• CHA Hopital Enfant-Jesus — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.