SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
- Registration Number
- NCT00076349
- Lead Sponsor
- Cephalon
- Brief Summary
SUMMARY:
This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression.
RATIONALE:
Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients.
PURPOSE:
This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 bendamustine and rituximab open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab
- Primary Outcome Measures
Name Time Method Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma 4-6 months
- Secondary Outcome Measures
Name Time Method • To characterize the safety profile of SDX-105 plus rituximab in this patient population • To determine the one-year and Kaplan-Meier estimates of progression-free survival (PFS) rates • To determine the median duration of response (DR) 4-6 months
Trial Locations
- Locations (34)
Beth Israel/Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Oncology and Hematology
🇺🇸Metairie, Louisiana, United States
Georgetown University Medical Center - Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Alaska Cancer Research and Education Center
🇺🇸Anchorage, Alaska, United States
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Queen Elizabeth II Health Sciences Centre-Victoria General Site
🇨🇦Halifax, Nova Scotia, Canada
San Diego Cancer Center
🇺🇸Vista, California, United States
Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center
🇺🇸Stamford, Connecticut, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
North Eastern Ontario Regional Cancer Center
🇨🇦Sudbury, ,, Ontario, Canada
Hopital Notre-Dame Du Chum
🇨🇦Montreal, Quebec, Canada
Bay Area Cancer Research Group
🇺🇸Concord, California, United States
USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
🇺🇸Los Angeles, California, United States
Wilshire Oncology Medical Group
🇺🇸La Verne, California, United States
Pasco Hernando Oncology
🇺🇸New Port Richey, Florida, United States
John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Suburban Hematology & Oncology Associates
🇺🇸Lawrenceville, Georgia, United States
Georgia Oncology Partners Research and Education Foundation
🇺🇸Macon, Georgia, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Hubert H. Humphrey Cancer Center
🇺🇸Robbinsdale, Minnesota, United States
The Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Arena Oncology Associates
🇺🇸Great Neck, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology
🇺🇸Rochester, New York, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Univ. of Virginia Health System-Cancer Center Clinical Trials Office
🇺🇸Charlottesville, Virginia, United States
St. Vincent's Hospital
🇦🇺Darlinghurst, Australia
The Royal Victoria Hospital Cancer Care Program Clinical Trials
🇨🇦Barrie, Ontario, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Westmead Hospital
🇦🇺Westmead, Australia
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
ACORN - West Cancer Center
🇺🇸Memphis, Tennessee, United States
Peter MacCallum Cancer Institute
🇦🇺East Melbourne, Victoria, Australia