Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
- 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
- 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 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.
Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response, unconfirmed complete response, and partial response) at 12 weeks
Robin Joyce, MD
Beth Israel Deaconess Medical Center
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Fletcher Allen Health Care - Medical Center Campus||Burlington, Vermont 05401|