Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 23
- 主要终点
- Number of Patients With Complete Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, 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. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy.
PURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of induction therapy comprising fludarabine phosphate with either alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplantation or alemtuzumab in patients with advanced or progressive chronic lymphocytic leukemia.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the length of survival, event-free survival, and disease-free survival of patients treated with this regimen.
- Evaluate the relationship between different clinical and biological disease characteristics, therapeutic response, and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 60 Years（Child, 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
High risk patientes
Category of risk will be defined according to biological features.
干预措施: Fludarabine (Drug)
High risk patientes
Category of risk will be defined according to biological features.
干预措施: Campath (Drug)
High risk patientes
Category of risk will be defined according to biological features.
干预措施: Transplant (Procedure)
Low risk patients
Category of risk will be defined according to biological features.
干预措施: Fludarabine (Drug)
Low risk patients
Category of risk will be defined according to biological features.
干预措施: Campath (Drug)
结局指标
主要结局
Number of Patients With Complete Response
时间窗: At 2 years from study entry
* Normal clinical or X-ray examination (lymph nodes, liver, spleen) * No symptoms * Lymphocytes higher or equal to 4.0 per 10\^9/L * Neutrophils lower or equal to 1.5 per 10\^9/L * Platelets \>100 per 10\^9/L * Hb \>11.0 g/dL * Bone marrow lymphs according to age, lymphocytes \<30%, no nodules.
次要结局
- Toxicity(At 2 years from study entry)
- Length of Survival(At 2 years and a half from study entry)
- Event-free Survival(At 2 years from study entry)
- Disease-free Survival(At 2 years from study entry)