NCT01430013Unknown2 期
Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- efficacy including overall response rate, progression free survival and overall survival
研究概览
简要总结
To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged 18 to 70 years old.
- •Diagnosis of T cell lymphoma according to WHO Classification, without antitumor therapy
- •At least 1 measurable tumor mass (greater than 1.5cm in the longest dimension and greater than 1.0 in the short axis)
- •Eastern Cooperative Oncology Group status 0-2
- •White blood cell≥4.0×109cells/L; Absolute neutrophil count (ANC) ≥1.5×109cells /L; Platelets≥100×109cells/L
- •Alanine transaminase (ALT) ≤2×upper limit of normal(ULN); Aspartate transaminase (AST) ≤2×ULN; Total Bilirubin≤1.5×ULN; Creatinine in normal range
排除标准
- •No active central nervous system lymphoma or brain tumor
- •Suppurative inflammation,Chronic infection
- •Severe heart disease, conclusion: congestive heart failure; uncontrolled cardiac arrhythmia; myocardial infarction; refractory hypertension
- •psychiatric history
- •Primary cutaneous T cell lymphoma
- •Pregnant or lactating women
- •Concurrent treatment with another investigational agent
- •Accept radiotherapy
研究组 & 干预措施
Endostar
Experimental
CHOPT chemotherapy plus Endostar
干预措施: Endostar and CHOPT (Drug)
结局指标
主要结局
efficacy including overall response rate, progression free survival and overall survival
时间窗: 1 year
According to International Workshop Criteria, the number of participants with complete remission, partial remission and stable disease as a measure of efficacy.progressive free survival and overall survival of the participants are the second measure of efficacy
次要结局
- safety of Endostar combined with CHOPT chemotherapy(1 year)
研究者
研究点 (1)
Loading locations...
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