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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Antibodies, Monoclonal; Rituximab

Criteria

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