Overview

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