Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Median Progression Free Survival (PFS)
研究概览
简要总结
Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
详细描述
The objective of this study is to estimate the median progression-free survival for patients receiving this regimen, along with the rate of complete response at 6 months, toxicities associated with this regimen, and laboratory correlates. Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3
- •Meeting FLIPI criteria for intermediate or high risk.
- •No prior chemotherapy, radiotherapy or immunotherapy for lymphoma;
- •Patients may not have known HIV infection, and must not be Hepatitis B Surface Antigen positive.
排除标准
- •May not be pregnant or breastfeeding, have documented CNS (Central Nervous System) disease, G-CSF (Granulocyte Colony Stimulating Facto) or GM-CSF (Granulocyte/Macrophage Colony Stimulating Factor) within 2 weeks prior
研究组 & 干预措施
Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance
干预措施: Ibritumomab Tiuxetan (Zevalin) + Rituximab (Drug)
结局指标
主要结局
Median Progression Free Survival (PFS)
时间窗: up to 5 years, 9.5 months, from first day on treatment to last follow up
Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma).
次要结局
- 24-month Progression Free Survival (PFS)(Up to 24 months)
- Response Rates(Up to 5 years and 9.5 months)
- Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0(Up to 5 years and 9.5 months)
- Overall Survival (OS)(At 12 months)