PHASE II TRIAL OF YTTRIUM-90-IBRITUMOMAB TIUXETAN (ZEVALIN) RADIOIMMUNOTHERAPY AFTER CYTOREDUCTION WITH ESHAP CHEMOTHERAPY IN PATIENTS WITH RELAPSED FOLLICULAR NON-HODGKIN'S LYMPHOMA
- To evaluate the 1-year progression-free survival of patients with relapsed stage II-IV
follicular non-Hodgkin lymphoma treated with ESHAP chemotherapy for cytoreduction
followed by yttrium Y 90 ibritumomab tiuxetan radioimmunotherapy.
- To evaluate the median time to progression in these patients.
- To evaluate the overall and complete response rates in patients treated with this
- ESHAP chemotherapy: Patients receive ESHAP chemotherapy comprising etoposide IV over 1
hour, methylprednisolone IV, cisplatin IV on days 1-4, and cytarabine IV over 2 hours
on day 1. Treatment repeats every 28 days for 2 courses in the absence of disease
progression or unacceptable toxicity.
- Radioimmunotherapy: Between 4-6 weeks after completion of ESHAP chemotherapy, patients
receive rituximab IV followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes
on day 1. Patients with < 25% bone marrow involvement and expected biodistribution
proceed to treatment. Patients receive rituximab IV followed by yttrium Y 90
ibritumomab tiuxetan IV over 10 minutes on day 7, 8, or 9.
After completion of study treatment, patients are followed periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 1 year
To evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy.
Thomas P. Miller, MD
University of Arizona
United States: Food and Drug Administration
|University of Arizona Cancer Center||Tucson, Arizona 85724|