NCT00003757已完成2 期
Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy.
详细描述
OBJECTIVES:
- Determine the rate of complete and partial remission, remission duration, and relapse free survival after treatment with rituximab in patients with refractory or recurrent hairy cell leukemia who previously received cladribine.
- Determine the acute and long term toxicity of rituximab in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV over several hours once a week for 4 weeks.
Patients are followed every 3 months for 3 years and every 6 months thereafter.
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:
- •Histologically proven hairy cell leukemia (HCL)
- •Classic HCL
- •Hairy cells in the bone marrow and/or peripheral blood which co-express CD20/CD25 or CD20/CD11c, and/or which are positive for tartrate resistant acid phophatase (TRAP)
- •Prolymphocytic HCL variant
- •Lymphoid cells in the bone marrow and/or peripheral blood with morphology intermediate between typical hairy cells and prolymphocytes, which co-express CD20/CD11c but lack CD25 expression, and which are negative for TRAP
- •Progressive or recurrent disease after prior treatment with cladribine
- •Greater than 1 month since standard dose cladribine OR
- •Greater than 3 months since low dose cladribine
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 2.3 mg/dL
- •Cardiovascular:
- •No serious cardiac disease
- •No acute or chronic infection
- •HIV negative
- •No psychosis
- •Not pregnant or nursing
- •No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •Recovered from prior therapy
- •No concurrent cytoreductive therapy
排除标准
- 未提供
研究者
研究点 (2)
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