Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have chronic myelogenous leukemia in chronic or accelerated phase.
研究概览
详细说明
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate, duration of response, and survival of patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic or accelerated phase.
- Assess the toxicity of this drug in these patients.
OUTLINE: Patients receive bortezomib intravenous (IV) over 3-5 seconds twice weekly on weeks 1-2. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 5-30 patients will be accrued for this study within 15-30 months.
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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Texas
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Houston、Texas、美国、77030-4009
- MD Anderson Cancer Center at University of Texas
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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:
Diagnosis of Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML) in chronic or accelerated phase, defined as having any of the following:
- Peripheral blood (PB) or bone marrow (BM) blasts at least 10% but less than 30%
- PB or BM blasts and promyelocytes at least 20%
- PB or BM basophils at least 20%
- Progressive splenomegaly (at least 10 cm confirmed twice at least 4 weeks apart or 50% increase in splenomegaly over 4 weeks)
- Clonal evolution defined as the presence of additional cytogenetic abnormalities other than the Ph chromosome
- Thrombocytopenia (platelet count less than 100,000/mm^3) unrelated to therapy
- Hemoglobin less than 7 g/dL unrelated to therapy or bleeding
- Failed prior treatment with imatinib mesylate or intolerant, unable, or unwilling to receive it
- Ineligible for higher-priority or higher-efficacy regimens or protocols
- No blastic phase CML
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy:
- At least 18 weeks
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Other:
- No other concurrent illness that would preclude study entry
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 2 prior cytotoxic regimens in addition to imatinib mesylate and/or hydroxyurea
- At least 4 weeks since prior chemotherapy and recovered
- Concurrent hydroxyurea and/or anagrelide allowed during first 2 courses
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Other:
- See Disease Characteristics
- See Chemotherapy
- At least 24 hours since prior imatinib mesylate
- No other concurrent investigational agents
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 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 (实际的)
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 (实际的)
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
其他研究编号
- CDR0000068872
- MDA-DM-00274
- NCI-1756
- DM00-274 (其他标识符:UT MD Anderson Cancer Center)
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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