Trials / Unknown
UnknownNCT00022685
Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
A Phase III Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (Rituximab)
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | epratuzumab |
Timeline
- Start date
- 2001-09-01
- First posted
- 2003-01-27
- Last updated
- 2013-12-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00022685. Inclusion in this directory is not an endorsement.