Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma
Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.
研究概览
详细说明
OBJECTIVES:
Primary
- Determine the response rate in patients with angioimmunoblastic T-cell lymphoma after chemotherapy comprising fludarabine and cyclophosphamide.
Secondary
- Assess the incremental anatomical and molecular response rate in these patients during treatment with thalidomide.
- Determine the toxicity of treatment with fludarabine and cyclophosphamide followed by thalidomide.
- Assess the progression-free and overall survival of these patients.
- Develop a detailed pathological description of the disease at presentation and at relapse.
- Assess the number of circulating clonal T cells at presentation and during thalidomide treatment.
- Screen for possible etiological viruses at presentation.
- Evaluate the evolution of EBV viral load during follow-up.
OUTLINE: This is a multicenter study.
Patients receive oral or IV fludarabine and oral or IV cyclophosphamide once daily on days 1-3. Courses repeat every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Beginning at least 4 weeks after completion of chemotherapy, patients who achieve at least stable disease receive oral thalidomide once daily for at least 6 months.
Lymph nodes, marrow, and peripheral blood will be collected periodically for research studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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England
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Exeter、England、英国、EX2 5DW
- 招聘中
- Cancer Research UK and University College London Cancer Trials Centre
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接触:
- Claudius Rudin, MD
- 电话号码:44-1392-402-850
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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:
- Newly diagnosed angioimmunoblastic T-cell lymphoma
- Measurable disease (i.e., anatomically assessable)
PATIENT CHARACTERISTICS:
- WHO/ECOG performance status 0-2
- Serum creatinine ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception before, during, and after study treatment
- No known seropositivity for hepatitis B virus, hepatitis C virus, or HIV
- No active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for angioimmunoblastic T-cell lymphoma
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)
研究衡量的是什么?
主要结果指标
结果测量 |
|---|
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Response rate after chemotherapy with fludarabine and cyclophosphamide
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次要结果测量
结果测量 |
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无进展生存期和总生存期
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Incremental response rate to thalidomide treatment
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Toxicity according to the NCI CTCAE v.3.0
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合作者和调查者
调查人员
- 首席研究员:Claudius Rudin, MD、Royal Devon and Exeter Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
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
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