Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma

The objective of this study is to determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in patients with low-grade lymphoma in first or second relapse treated with Zevalin followed by 2 years of Rituxan maintenance therapy in a multicenter, community-based setting, as well as evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.

To meet the initial trial enrollment goal of 300 patients over two years, 42 total sites were activated. The study has subsequently closed to accrual. Currently 8 sites remain active to follow the 12 subjects enrolled in the past year.

Inclusion criteria

• Follicular non-Hodgkin's lymphoma including SLL in first or second relapse.
• No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory.
• Age >= 18 years, not pregnant or lactating.
• Expected survival >= 3 mths; PS 0, 1, or 2.
• ANC >= 1,500/mm3, platelet counts >= 100,000/mm3.
• Total bilirubin > 2.0 mg/dL, creatinine > 2.0 mg/dL.
• Total lymphocyte count < 5,000/mm3 for SLL.
• <25% bone marrow involvement with lymphoma.

Exclusion criteria

• Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection.
• Bulky areas of disease more than 10 cm in diameter.
• Patients with CLL, CNS, or mantle cell lymphoma.
• Hx of HIV/AIDS related lymphoma, hepatitis B or C.
• Prior radioimmunotherapy or XRT to >25% of active bone marrow.
• G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment