Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell Non-Hodgkin's Lymphoma
- Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when
administered with rituximab in patients with B-cell non-Hodgkin's lymphoma who have
relapsed after high-dose chemotherapy and autologous hematopoietic stem cell
- Determine the safety and efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan
- Phase I: Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled
ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients receive
rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes.
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience
- Phase II: Once the MTD is determined, 58 additional patients are treated at that dose
level as in phase I.
Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and
then annually thereafter.
PROJECTED ACCRUAL: Approximately 78 patients (20 for phase I and 58 for phase II) will be
accrued for this study within 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Julie M. Vose, MD
University of Nebraska
United States: Food and Drug Administration
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|