A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma
OBJECTIVES:
Primary
- 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
first-line treatment.
Secondary
- 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
patients.
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response, unconfirmed complete response, and partial response) at 14 weeks
No
Robin Joyce, MD
Study Chair
Beth Israel Deaconess Medical Center
Unspecified
CDR0000409723
NCT00110149
May 2004
Name | Location |
---|---|
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 |