A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation
I. Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) in
patients with post-transplant lymphoproliferative disorder.
II. Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients.
III. Correlate the Epstein-Barr virus viral load with response and relapse in patients
treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10
minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the
absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by
IDEC-Y2B8 IV over 10 minutes on day 8.Cohorts of 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 no more than 1 of 6 patients experience dose-limiting toxicity.
Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are
followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimated using binomial proportions and their 95% confidence intervals.
Up to 4 years
AIDS Associated Malignancies Clinical Trials Consortium
United States: Food and Drug Administration
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