Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining epirubicin with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
- Determine the response rate, time to progression, and overall survival of patients with refractory or relapsed B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with epirubicin and rituximab.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive epirubicin IV over 3-5 minutes once weekly for 6 weeks. Patients also receive rituximab IV on weeks 2 and 5 during course 1 and then on weeks 1 and 4 for all remaining courses. Treatment repeats every 8 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression.
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 confirmed B-cell non-Hodgkin's lymphoma (any grade) or chronic lymphocytic leukemia meeting 1 of the following criteria:
- •Primary refractory disease
- •Disease progression after at least 1 but no more than 4 prior cytotoxic chemotherapy regimens
- •Rituximab administered alone is not considered 1 prior regimen
- •High-dose chemotherapy with stem cell support is considered 1 prior regimen
- •Bidimensionally measurable or evaluable disease outside prior irradiation port
- •No clinical evidence of CNS involvement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count at least 2,000/mm^3*
- •Platelet count at least 100,000/mm^3* NOTE: *Unless due to bone marrow involvement
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT and SGPT no greater than 2 times upper limit of normal (ULN)
- •Creatinine no greater than 2 times ULN
- •Cardiovascular
- •No unstable angina
- •No uncontrolled congestive heart failure
- •LVEF at least 45%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study treatment
- •HIV negative
- •No other concurrent primary malignancy except basal cell or squamous cell skin cancer, carcinoma in situ, or localized solid tumors cured more than 5 years ago
- •No acute infection requiring systemic therapy
- •No confusion, disorientation, or major psychiatric illness that would preclude understanding of informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •At least 4 weeks since prior biologic therapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •Prior cumulative doxorubicin dose no greater than 6 courses at 50 mg/m^2
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •No prior radiotherapy to the entire pelvis
- •At least 4 weeks since prior radiotherapy
- •Not specified
- •More than 7 days since prior cimetidine
- •No concurrent cimetidine
排除标准
- 未提供