A Phase I/II Trial of Escalating Dose of Yttrium-90-labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplantation for Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma
- To evaluate the safety and efficacy of a new preparative regimen of yttrium Y 90
ibritumomab tiuxetan in combination with high-dose etoposide and cyclophosphamide
followed by autologous stem cell transplantation (ASCT) for treatment of patients with
poor-risk, relapsed, or refractory non-Hodgkin lymphoma (NHL).
- To determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan which can
be given with high-dose etoposide and high-dose cyclophosphamide followed by ASCT in
patients with NHL.
- To perform dosimetry study to estimate the radiation dose delivered to the tumor and
- To evaluate the short-term and long-term complications of this new preparative regimen.
OUTLINE: This is a phase I does-escalation study of yttrium Y 90 ibritumomab tiuxetan
followed by an open-label phase II study.
- Preparation for transplantation: Peripheral blood stem cells (PBSCs) are collected via
leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene
rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3
times 10^6 /kg) proceed to radioimmunotherapy.
- Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan IV on days -21
and -14. Patients undergo bone marrow biopsy and dose estimation on day -7.
- Chemotherapy: Patients receive etoposide IV on day -4 and cyclophosphamide IV over 2
hours on day -2.
- Transplantation: Patients undergo reinfusion of PBSCs on day 1.
- Growth factor therapy: Patients receive filgrastim (G-CSF) IV beginning on day 1 and
continuing until blood counts recover.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Masking: Open Label, Primary Purpose: Treatment
Auayporn P. Nademanee, MD
Beckman Research Institute
United States: Food and Drug Administration