Zevalin And Rituxan For The Treatment Of 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 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response, unconfirmed complete response, and partial response) at 12 weeks
No
Robin Joyce, MD
Study Chair
Beth Israel Deaconess Medical Center
Unspecified
CDR0000341437
NCT00073957
December 2003
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Fletcher Allen Health Care - Medical Center Campus | Burlington, Vermont 05401 |