Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma, Low-GradeLymphoma, Non-Hodgkin
- Registration Number
- NCT00168727
- Lead Sponsor
- Biogen
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (8)
Loma Linda University
🇺🇸Loma Linda, California, United States
Northwest Oncology and Hematology
🇺🇸Elk Grove Village, Illinois, United States
Medical Specialists of Fairfield
🇺🇸Fairfield, Connecticut, United States
North County Oncology
🇺🇸Oceanside, California, United States
Horizon Oncolgy Center
🇺🇸Lafayette, Indiana, United States
Presbyterian Hospital Cancer Center
🇺🇸Charlotte, North Carolina, United States
Specialists in Hematology/Oncology
🇺🇸Saint Louis, Missouri, United States
Queens Hospital
🇺🇸Honolulu, Hawaii, United States