Lymphoma Clinical Trial
Official title:
Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell 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. Combining yttrium Y 90 ibritumomab tiuxetan with
rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab
tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large
B-cell non-Hodgkin's lymphoma.
OBJECTIVES:
- Determine the best overall response in patients with relapsed or refractory diffuse
large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and
rituximab.
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
- Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10
minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10
minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.
- CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising
intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT
cytarabine (liposomal) on days 15 and 29.
- Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month
6, patients with stable or responding disease receive maintenance therapy comprising
rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6
months for 2 years (total of 4 courses) in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
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