Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00022685
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.
- Detailed Description
OBJECTIVES:
* Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma.
* Confirm the convenient administration of this drug in this patient population.
* Determine the efficacy of this drug in terms of objective response rate in these patients.
* Determine the duration of response and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and 22.
Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years.
PROJECTED ACCRUAL: Approximately 30-100 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States