Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
- Assess the clinical response rate (complete response [CR], unconfirmed CR, and partial
response) in patients with previously untreated marginal zone lymphoma treated with
yttrium Y 90 ibritumomab tiuxetan and rituximab.
- Determine progression-free survival, in terms of time to relapse or progression, of
patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Assess local disease control in these patients
- Evaluate the safety and tolerability of this regimen in these patients.
OUTLINE: Patients receive rituximab IV and indium In 111 ibritumab tiuxetan IV over 10
minutes on day 1. Patients with acceptable biodistribution receive rituximab IV and yttrium
Y 90 ibritumomab tiuxetan IV on day 7, 8, or 9.
After the completion of study treatment, patients are followed every 3 months for 2 years
and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response rate (complete response [CR], unconfirmed CR, and partial response)
Izidore S. Lossos, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|