Rituximab and GM-CSF in Treating Patients With Chronic Lymphocytic Leukemia
A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia
RATIONALE: Monoclonal antibodies, such as rituximab, 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying how well giving rituximab together with GM-CSF works in treating patients with B-cell chronic lymphocytic leukemia.
研究概览
详细说明
OBJECTIVES:
- Determine the complete and overall response rate in patients with B-cell chronic lymphocytic leukemia treated with rituximab and sargramostim (GM-CSF).
- Determine the time to progression in patients treated with this regimen.
- Determine the effects of this regimen on CD20 antigen expression and soluble CD20 levels in these patients.
OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease status
Patients receive rituximab IV on days 4, 11, 18, and 25 and sargramostim (GM-CSF) subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40, 43, 45, 47, 50, 52, and 54 (course 1). Patients with responding disease may receive an additional course of treatment.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
研究类型
阶段
- 阶段2
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:
Diagnosis of B-cell chronic lymphocytic leukemia meeting 1 of the following criteria:
Previously treated stage III or IV or earlier stage disease with evidence of active disease, as defined by ≥ 1 of the following:
- Weight loss > 10% within the past 6 months
- Extreme fatigue
- Fever or night sweats without evidence of infection
- Worsening anemia or thrombocytopenia
- Progressive lymphocytosis with a rapid lymphocyte doubling time
- Marked hypogammaglobulinemia or paraproteinemia
- Lymphadenopathy > 5 cm in diameter
- Previously untreated stage 0-II disease with symptoms or significant fatigue or at high risk of progression due to of B2 microglobulin > 3.0 mg/mL
- Patients who are ≥ 70 years of age with previously untreated stage III or IV or earlier stage disease requiring treatment but who refused chemotherapy are eligible
PATIENT CHARACTERISTICS:
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin < 2.0 mg/dL* (elevated bilirubin allowed if due to of Gilbert's disease) NOTE: *Liver dysfunction due to lymphocytic organ infiltration allowed
Renal
- Creatinine < 2.5 mg/dL* NOTE: *Renal dysfunction due to lymphocytic organ infiltration allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active viral infection (e.g., viral hepatitis)
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
研究衡量的是什么?
主要结果指标
结果测量 |
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整体回复率
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合作者和调查者
调查人员
- 学习椅:Ian W. Flinn, MD, PhD、Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
其他相关的 MeSH 术语
其他研究编号
- J0546 CDR0000450145
- P30CA006973 (美国 NIH 拨款/合同)
- P01CA081534 (美国 NIH 拨款/合同)
- JHOC-J0546
- JHOC-05070103
- CLLRC-008
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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