NCT00458523已完成2 期
Eradication of Minimal Residual Disease (MRD) in Patients With Chronic Lymphocytic Leukaemia (CLL) With Alemtuzumab: A Phase II Study
Leeds Cancer Centre at St. James's University Hospital4 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2006年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Rate of undetectable minimal residual disease (MRD) after completion of alemtuzumab therapy
研究概览
简要总结
RATIONALE: 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.
PURPOSE: This phase II trial is studying the side effects and how well alemtuzumab works in treating patients with B-cell chronic lymphocytic leukemia in partial remission or complete remission.
详细描述
OBJECTIVES:
Primary
- Determine the rate of achieving minimum residual disease (MRD) negativity after treatment with alemtuzumab in patients with B-cell chronic lymphocytic leukemia (B-CLL) who have low levels of MRD after conventional therapy or who relapse at an MRD level after a prior MRD-negative remission.
- Determine the safety of alemtuzumab in patients treated in the MRD-positive setting.
Secondary
- Determine the clinical response in patients treated with this drug.
- Determine the time to MRD relapse in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the effect of this drug when administered as consolidation/maintenance therapy on CD52 expression on CLL cells.
- Determine the safety and efficacy of repeated drug dosing required to achieve sustained MRD negativity in these patients.
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) meeting the following criterion:
- •Confirmed by characteristic immunophenotype on peripheral blood flow cytometry
- •In complete or partial remission after prior therapy for B-CLL
- •No treatment failure after receiving prior alemtuzumab therapy
- •Minimal residual disease (MRD) status meeting 1 of the following criteria:
- •Detectable B-CLL MRD (i.e., MRD-positive) as shown by peripheral blood or bone marrow involvement
- •Undetectable B-CLL MRD (i.e., MRD-negative remission)
- •Lymph nodes < 2 cm in maximum diameter
- •No persisting severe pancytopenia due to prior therapy rather than disease, as defined by the following criteria:
- •Neutrophil count < 5,000/mm^3
- •Platelet count < 50,000/mm^3
- •No clinically progressive disease (i.e., peripheral blood B-cell count ≥ 5,000/mm³)
- •No mantle cell lymphoma
- •No CNS involvement with B-CLL
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- •Creatinine < 2 times upper limit of normal (ULN)*
- •Bilirubin < 2 times ULN*
- •No known HIV positivity
- •No concurrent active infection
- •No history of anaphylaxis after exposure to rat or mouse-derived, complementary-determining region-grafted humanized monoclonal antibodies
- •No other concurrent severe diseases or mental disorders
- •No concurrent active secondary malignancy NOTE: *Unless secondary to direct infiltration of the liver by B-CLL or hemolysis
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior allogeneic stem cell transplantation
- •Any other prior therapy allowed
- •At least 6 months since completion of last therapy for B-CLL
- •More than 6 weeks since prior investigational agents
- •No other concurrent cytotoxic agents
排除标准
- 未提供
结局指标
主要结局
Rate of undetectable minimal residual disease (MRD) after completion of alemtuzumab therapy
Rate of unacceptable toxicities
次要结局
- Rate of overall response (complete or partial response)
- Time to MRD relapse
- Overall survival
- Expression of CD52 on chronic lymphocytic leukemia cells
- Rate of re-achievement of MRD negativity after completion of alemtuzumab therapy
- Incidence of successful retreatment
- Toxicity from repeated therapy
- Length of interval between required treatments
研究者
研究点 (4)
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