Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL
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.
研究概览
详细说明
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.
PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study within 2.5-3 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19111
- Fox Chase Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
Age
- 18 and over
Performance status
- ECOG 0-2
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
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT and SGPT no greater than 2 times upper limit of normal (ULN)
Renal
- Creatinine no greater than 2 times ULN
Cardiovascular
- No unstable angina
- No uncontrolled congestive heart failure
- LVEF at least 45%
Other
- 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
Surgery
- Not specified
Other
- More than 7 days since prior cimetidine
- No concurrent cimetidine
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- FCCC-02025
- CDR0000304711 (注册表标识符:PDQ (Physician Data Query))
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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