Consolidation Therapy With Lenalidomide (Revlimid®) With or Without Rituximab Followed by Maintenance Therapy With Revlimid® After Autologous/Syngeneic Transplant for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
研究概览
简要总结
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether lenalidomide is more effective with or without rituximab in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This phase II trial is studying how well lenalidomide works when given with or without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplant.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of consolidation therapy comprising lenalidomide with or without rituximab followed by maintenance therapy comprising lenalidomide in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplantation.
OUTLINE:
- Consolidation phase: Patients are assigned to 1 of 2 treatment groups.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group I (consolidation phase)
Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: lenalidomide (Drug)
Group II (consolidation phase)
Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
干预措施: rituximab (Biological)
Group II (consolidation phase)
Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
干预措施: lenalidomide (Drug)
结局指标
主要结局
Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
Disease-free survival at 2 years after transplant
次要结局
- Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0
- Ability to complete planned therapy
- Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy
- Time to disease progression
- Relapse rates