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
1 other identifier
interventional
72
2 countries
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2003
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 30, 2003
CompletedFirst Posted
Study publicly available on registry
October 2, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMay 9, 2014
May 1, 2014
3.6 years
September 30, 2003
May 8, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (17)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Comprehensive Cancer Center-Desert Regional Medical Center
Palm Springs, California, 92262, United States
San Diego Cancer Center
Vista, California, 92083, United States
Georgetown University Medical Center - Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
CHA Hopital Enfant-Jesus
Québec, Quebec, G1J 1Z4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2003
First Posted
October 2, 2003
Study Start
September 1, 2003
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
May 9, 2014
Record last verified: 2014-05