Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- side effects
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas (PTCL). 30 patients will be treated into this study.
详细描述
Doxorubicin is often used to treat Peripheral T-cell lymphomas (PTCL). However, patients with PTCL have an especially poor outcome with a 5-year overall survival rate of only 26% following treatment with standard doxorubicin containing regimens. There is general agreement that results with conventional chemotherapy are so poor in patients with most PTCL that new approaches are warranted.The nucleoside analogs are Fludarabine being combined with other agents in PTCL (excluding ALK positive ALCL and primary cutaneous ALCL) is reported by others.We conduct a II stage clinical trials to evaluate the efficacy of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with in Newly Diagnosed PTCL.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of peripheral T cell lymphoma must established by histological biopsy, and immunochemistry analysis and cytogenetic assessment should be done as well. The patients with peripheral T cell lymphoma (PTCL), PTCL-unspecified type(PTCL-u), angioimmunoblastic lymphoma (AILT) and non-skin type anaplastic large cell lymphoma (ALCL, ALK-).
- •Good performance status, ECOG score≤
- •Estimated survival span >3 months
- •Previously untreated.
- •At least 1 assessable disease (maximal diameter >1.0cm, the disease foci located within the irradiated area are excluded) evaluated by CT or MRI, PET is also permitted.
- •Good compliance and inform consenting
- •Fit for the following criteria:
- •Absolute neutrophil count (ANC)≥1.5×109/L
- •Platelet（PLT）≥80×109/L
- •Total bilirubin (TBI) ≤upper normal limit (UNL)
- •Serum creatine (Cr) ≤UNL
- •Alanine aminotransferase (ALT) and Aspartate transaminase（AST）≤1.5 UNL
排除标准
- •Severe cardiac, renal or hepatic incompetence: serum direct bilirubin, indirect bilirubin, ALT, AST and Cr greater than 1.5 UNL; cardiac function greater than grade II. 28 days within the major surgical operation.
- •Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)
- •Severe uncontrolled underlying diseases
- •Pregnancy or lactation
- •Autoimmune disease history
- •Severe infection or metabolic diseases
- •Known allergic to multiple agents, including sulphanilamide.
- •Severe peptic ulceration or bleeding, contra-indicative for corticosteroids
- •Lymphoma involving central nervous system
研究组 & 干预措施
A
干预措施: FAD (Drug)
结局指标
主要结局
side effects
时间窗: 1 months
次要结局
- PFS (progression free survival)(3 months)
- complete remission(CR)(2 months)