A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma
- Determine 12-week overall and complete response rate in patients with indolent
non-Hodgkin's lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as
- Determine 1-year event-free survival of patients treated with this regimen.
- Determine time to progression and time to next antilymphoma therapy in patients treated
with this regimen.
- Determine the molecular response rate in patients treated with this regimen.
- Determine the hematological and non-hematological toxicity of this regimen in these
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV followed, no more than 4 hours later, by indium In 111
ibritumomab tiuxetan (for imaging) IV over 10 minutes on day 1. If biodistribution is
acceptable, patients receive rituximab IV followed, no more than 4 hours later, by a single
dose of yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8, or 9 in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, weeks 6, 10, and 14, every 3 months for 2 years,
and then every 6 months for 2 years.
After completion of study treatment, patients are followed weekly for 3 months, every 3
months for 2 years, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 18-28 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 14 weeks
Robin Joyce, MD
Beth Israel Deaconess Medical Center
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Vermont Cancer Center at University of Vermont||Burlington, Vermont 05405-0075|