NCT00180882Unknown3 期
LMBA02 Protocol for Patients With a Burkitt Lymphoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Event free survival from date of first randomization
研究概览
简要总结
To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 18 years or older
- •Histologically or cytologically proven Burkitt lymphoma according to the WHO classification
- •WHO performance < 3
- •Informed consent
排除标准
- •Known HIV positive infection
- •Positive serology for HCV and HBV (except after vaccination)
- •Patients previously treated for lymphoma
- •cardiac disease that contradict anthracycline chemotherapy
- •Psychological or psychiatric condition who contradict steroids therapy
- •Patients with serious renal failure unrelated to the lymphoma (serum creatinin level higher than 150 mmole/L)
- •Cirrhosis or severe hepatic failure unrelated to the lymphoma
- •Previous malignant disease except basal cell skin carcinoma or in situ uterine cervix carcinoma
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Primary organ transplant or other immunosuppressive conditions Pregnancy
结局指标
主要结局
Event free survival from date of first randomization
次要结局
- Complete and partial response rate, overall survival, toxicity
研究者
研究点 (2)
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