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)
Alaska Cancer Research and Education Center
🇺🇸Anchorage, Alaska, United States
Bay Area Cancer Research Group
🇺🇸Concord, California, United States
Wilshire Oncology Medical Group
🇺🇸La Verne, California, United States
USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
🇺🇸Los Angeles, California, United States
San Diego Cancer Center
🇺🇸Vista, California, United States
Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center
🇺🇸Stamford, Connecticut, United States
Georgetown University Medical Center - Lombardi Cancer Center
🇺🇸Washington, District of Columbia, 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
Scroll for more (24 remaining)Alaska Cancer Research and Education Center🇺🇸Anchorage, Alaska, United States