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

Completed · Phase 4

Conditions studied: Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade

In brief

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.

Key facts

Study ID

NCT00168727

Run by

Biogen

People needed

12

Starts

2003-06-01

Expected to finish

2005-10-31

Last updated by the study team

2023-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Loma Linda University — Loma Linda, California, United States
• North County Oncology — Oceanside, California, United States
• Medical Specialists of Fairfield — Fairfield, Connecticut, United States
• Queens Hospital — Honolulu, Hawaii, United States
• Northwest Oncology and Hematology — Elk Grove Village, Illinois, United States
• Horizon Oncolgy Center — Lafayette, Indiana, United States
• Specialists in Hematology/Oncology — St Louis, Missouri, United States
• Presbyterian Hospital Cancer Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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