Zevalin® (Ibritumomab Tiuxetan) Followed by Rituxan® (Rituximab) Maintenance in Previously Treated Low Grade Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 12
- 试验地点
- 9
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •ANC >= 1,500/mm3, platelet counts >= 100,000/mm
- •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.
排除标准
- •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
结局指标
主要结局
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
次要结局
- 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.