Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 31
- 主要终点
- Efficacy of chemotherapy
研究概览
简要总结
Nasal/nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin's lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples.
The investigators propose a phase II protocol for patients with refractory or relapsing nasal/nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy.
Since january 2009, the study concerns all patients with nasal/nasal type NK-T-cell lymphoma who have not received asparaginase before.
详细描述
Primary Objective:
- Determine the overall and complete response rate
Secondary Objectives:
- To evaluate survival without progression
- To evaluate total survival.
- To evaluate the tolerance and the side effects of the treatment.
- To evaluate the duration and the mode of hospitalization of the patients treated by this therapeutic association.
- To constitute a bank of biological samples - serum, tumoral, ADN, ARN to allow prognostic studies implying virus EBV, p53, CD94, C-kit and asparagine synthetase gene in order to better understand the mechanisms of the cancerogenesis of this variety of cytotoxic LNH and to identify the predictive factors of response to the asparaginase.
Sampling:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with relapsing/refractory T-NK/NK lymphoma:
- •Ages 18 years and above
- •Patients must have a diagnosis of NK-cell (or T-NK) non-Hodgkin's lymphoma, nasal or nasal-type.
- •Stage I, II, III, or IV disease
- •Creatinine less than 3 x upper limit of normal (ULN)
- •Able to give informed consent
- •No prior treatment with asparaginase
- •Patients with T-NK/NK lymphoma (de novo patients ):
- •Ages 18 years and above
- •Patients must have a diagnosis of NK-cell (or T-NK) non-Hodgkin's lymphoma, nasal or nasal-type.
- •Stage I, II, III, or IV disease
- •Creatinine less than 3 x upper limit of normal (ULN)
- •Able to give informed consent
- •no prior chemotherapy or radiotherapy
排除标准
- •Patients who are pregnant or nursing
- •Any factor which might limit the patient's ability to provide informed consent
- •Liver insufficiency
- •Evolutive thrombosis
结局指标
主要结局
Efficacy of chemotherapy
时间窗: 3 month, 6 month, 9 month, 12 month, 18 month, 24 month
次要结局
未报告次要终点