Antibody Therapy With Alemtuzumab and Rituximab for Initial Treatment of High Risk Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Related Adverse Events
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as alemtuzumab and 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. Giving alemtuzumab together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving alemtuzumab together with rituximab works in treating patients with high-risk, early-stage chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the rate of complete and overall response to alemtuzumab and rituximab in patients with high-risk, early-stage chronic lymphocytic leukemia.
- Determine the toxicity of this regimen in these patients. Secondary
- Determine the overall survival and time to progression of patients treated with this regimen.
- Determine time to response and duration of response in patients treated with this regimen.
- Correlate prognostic markers 11q-, 17p-, unmutated VH gene, and CD38+ with clinical outcome.
- Determine response to this regimen using an expanded definition of response that includes minimal residual disease detected by sensitive flow cytometry in patients in complete clinical remission and single rearranged IgVH gene detected by polymerase chain reaction in patients with no monoclonal population on flow cytometry.
- Correlate in vitro response with clinical outcome in patients treated with this regimen.
- Determine if alemtuzumab and rituximab are synergistic in vitro.
- Determine the mechanism of action of this regimen in vitro.
- Determine the effect of this regimen on immune function.
- Monitor T-lymphocyte, natural killer cell, and monocyte number during and after treatment in these patients.
- Serially evaluate T-lymphocyte immunophenotype and function in patients treated with this regimen.
- Monitor recovery of humoral immunity by serial serum protein electrophoresis, immunofixation electrophoresis, and immunoglobulin quantification.
OUTLINE:
- Dose-escalation (week 1): Patients receive rituximab IV on day 1 and escalating doses of alemtuzumab subcutaneously (SC) on days 3-5 in week 1.
- Treatment (weeks 2-5): Patients receive alemtuzumab SC on days 1-3 (at the highest dose administered during week 1) and rituximab IV on day 3 in weeks 2-5 in the absence of disease progression or unacceptable toxicity.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Alemtuzumab + Rituximab
Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
干预措施: Alemtuzumab (Drug)
Alemtuzumab + Rituximab
Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of Participants With Treatment Related Adverse Events
时间窗: Weekly for first 6 weeks, then monthly for 6 months, then at 9 and 12 months post registration
Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.\> \> Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE
Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months
时间窗: Up to 6 months
Confirmed response is defined as a \> 50% decrease in clinical symptoms from baseline and recovery from blood counts.
次要结局
- Survival(Death or last follow-up (up to 5 years))
- Time to Disease Progression(Time from registration to progression (up to 5 years))
- Time to Response(Registration to first response (up to 5 years))
- Duration of Response(Up to 5 years)