Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00042913
- 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: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the response rate of patients with diffuse large B-cell non-Hodgkin's lymphoma treated with epratuzumab.
* Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 4 weeks.
* Arm II: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 8 weeks.
* Arm III: Patients receive high-dose epratuzumab IV over 1 hour once weekly for 4 weeks.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) 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
Jonsson Comprehensive Cancer Center, UCLA🇺🇸Los Angeles, California, United States