Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Best Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab.
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
- Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.
- CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29.
- Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Y-90 Ibritumomab Tiuxetan
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine
干预措施: rituximab (Biological)
Y-90 Ibritumomab Tiuxetan
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine
干预措施: cytarabine (Drug)
Y-90 Ibritumomab Tiuxetan
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine
干预措施: liposomal cytarabine (Drug)
Y-90 Ibritumomab Tiuxetan
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine
干预措施: yttrium Y 90 ibritumomab tiuxetan (Radiation)
结局指标
主要结局
Best Response
时间窗: 12 months
This data is the best overall response achieved by patients by the 12 month period.
Response Rate = Complete and Partial Response at 12 Weeks.
时间窗: 12 weeks
Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) \> 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node \> 1 cm in short axis \> 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy
次要结局
- Event Free Survival(12 months)
研究者
Robin Joyce
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center