NCT00145002已完成3 期
Phase III Study of VCAP-AMP-VECP vs. Biweekly CHOP in Aggressive Adult T-cell Leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.
详细描述
Nothing to describe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ATL was made based on seropositivity for HTLV-I by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral T-cell malignancy
- •Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL
- •Aged 15-69 years
- •No prior chemotherapy or radiotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia
- •Preserved organ (bone marrow, liver, kidney, heart and lung) functions
- •All patients were required to provide written informed consent
排除标准
- •Diabetes mellitus necessitating treatment with insulin
- •Active systemic infection
- •Cardiac disorders expected to become worse as a result of the DOX-containing regimen
- •Acute hepatitis, chronic hepatitis or liver cirrhosis
- •Positive for HBs Ag or anti-HCV Ab
- •Active concurrent malignancy
- •Other serious medical or psychiatric conditions
- •Pregnancy or breast feeding
- •Central nervous system involvement by ATL cells
结局指标
主要结局
Overall survival
次要结局
- Progression free survival
- CR rate
- Toxicity
研究者
研究点 (2)
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