NCT00958854Unknown2 期
Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Response rate after chemotherapy with fludarabine and cyclophosphamide
研究概览
简要总结
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.
详细描述
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.
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:
- •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
排除标准
- 未提供
结局指标
主要结局
Response rate after chemotherapy with fludarabine and cyclophosphamide
次要结局
- Incremental response rate to thalidomide treatment
- Toxicity according to the NCI CTCAE v.3.0
- Progression-free and overall survival
研究者
研究点 (1)
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