NCT00262210已完成2 期
A Comparative Study for Non-Hodgkin's Lymphoma in Hepatitis B Virus Carriers
National Health Research Institutes, Taiwan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 1995年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- We expect to enter 25 patients per year and finish accrual of patients within 4 years.
研究概览
简要总结
* AIMS OF THE STUDY
- To test if steroid-free chemotherapeutic regimens decrease the risk of HBV reactivation and hepatitis development in HBsAg (+) carriers.
- To compare the efficacy of steroid-free chemotherapeutic regimens with that of steroid-containing regimens in terms of lymphoma control.
- To study the change of activity of HBV and other hepatotropic viruses during the course of chemotherapy.
详细描述
* TREATMENT PLANS FOR FIRST-LINE AND SECOND LINE CHEMOTHERAPY
- First-line Chemotherapy 1.1 PACE and ACE Treatment Scheme of PACE and ACE* Cyclophosphamide 650 mg/m2, i.v. Day 1 Epirubicin 60 mg/m2, i.v. Day 1 Etoposide 55 mg/m2/d, i.v. Day 1-3 Prednisolone 60 mg/m2/d, p.o. Day 1-7
- For ACE, prednisolone is omitted. 1.2 Courses will be repeated every 21 days. 1.3 For patients with CR, give at least 2 additional courses for a minimum of 6 courses.
1.4 For patients with PR or SD, may change to second-line chemotherapy if no further tumor shrinkage between two consecutive courses.Local radiotherapy is allowed for residual localized tumors.
1.5 For patients with PD, change to second-line chemotherapy . 2. Second-line Chemotherapy : For patients who have failed steroid-containing or steroid- free chemotherapy, respective steroid-containing and steroid-free salvage chemotherapy should be used.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Histologically proven NHL, and for which intensive chemotherapy is considered treatment-of-choice.
- •HBsAg-positive.
- •No previous chemotherapy and radiotherapy.
- •No concurrent radiotherapy. AGC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
- •Total bilirubin ≦ 2.5 mg/dl. Alanine aminotransferase (SGPT) < 200 I.U/L
- •Serum creatinine ≦1.5 mg/dl Blood urea nitrogen (BUN) ≦ 25 mg/dl
- •Objectively measurable or evaluable disease
- •Signed informed consent
排除标准
- •Age > 75 years, or Age < 15 years
- •Pregnant or breast-feeding women.
- •Patients with history of brain metastasis or CNS involvement.
- •Child's class B or C in patients with liver cirrhosis.
- •Impaired cardiac function with NYHA (New York Heart Association) classification ≧ GrII.
- •Concurrent glucocorticoids use (for other reasons). The conventional use of glucocorticoids for antiemetic purpose is also not allowed.
结局指标
主要结局
We expect to enter 25 patients per year and finish accrual of patients within 4 years.
次要结局
未报告次要终点
研究者
研究点 (1)
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