Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 29
- 主要终点
- Objective response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.
详细描述
OBJECTIVES:
- Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab.
- Determine the time to treatment failure in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12.
Patients are followed every 6 months for 2 years.
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 Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)
- •Immunoglobulin (Ig) M, IgG, and IgA paraprotein
- •Measurable monoclonal paraprotein
- •Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
- •CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 500/mm^3
- •Platelet count ≥ 25,000/mm^3
- •SGOT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2.5 times ULN
- •Creatinine ≤ 2.5 mg/dL (> 2.5 mg/dL allowed if due to disease)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-method contraception during and for 6 months after study participation
- •No serious comorbid disease
- •No uncontrolled bacterial, fungal, or viral infection
- •No other active malignancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •No prior alemtuzumab
- •More than 3 months since other prior monoclonal antibody therapy
- •Chemotherapy
- •See Disease Characteristics
- •More than 21 days since prior chemotherapy
- •Endocrine therapy
- •More than 21 days since prior steroid therapy
- •Radiotherapy
- •More than 21 days since prior radiotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Objective response
Time to treatment failure
Toxicity
次要结局
未报告次要终点