Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with progressive non-Hodgkin's lymphoma.
Radiation: yttrium Y 90 ibritumomab tiuxetan
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study To Evaluate The Safety And Efficacy Of Zevalin (IND # BB IND 4850) Therapeutic Regimen In Patients With Transformed CD20 + B-Cell Non-Hodgkin's Lymphoma|
- Overall response rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Complete response (CR), unconfirmed CR, and partial response [ Designated as safety issue: No ]
- Event-free survival [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Time to next lymphoma treatment [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
- Determine the efficacy of yttrium Y 90 ibritumomab tiuxetan and rituximab, in terms of overall response rate (complete, unconfirmed complete, and partial) and duration of response, in patients with transformed CD20+ B-cell non-Hodgkin's lymphoma.
- Determine the safety of this regimen in these patients.
- Determine the event-free survival and time to treatment progression in patients treated with this regimen.
- Determine the immunogenicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV followed within 4 hours by indium In 111 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 18-24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062114
Show 94 Study Locations
|Study Chair:||Thomas C. Shea, MD||UNC Lineberger Comprehensive Cancer Center|
|Study Chair:||Fay Young, MD||James P. Wilmot Cancer Center|
|Study Chair:||Andrew M. Evens, DO, MS||Robert H. Lurie Cancer Center|