ISRCTN52265296已完成不适用
A phase II study of anti-CD52 monoclonal antibody (Alemtuzumab, MabCampath®) with 2-weekly CHOP chemotherapy (Camp-CHOP 14) in patients with mature T-cell non-Hodgkin's lymphoma
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 20 人开始时间: 2010年7月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with a confirmed histologic diagnosis of T-cell non-Hodgkin's lymphoma (T-NHL) according to the World Health Organization (WHO) classification:
- •1.1. Extranodal NK/T cell lymphoma, nasal type
- •1.2. Enteropathy-type T-cell lymphoma (EATL), if measurable disease
- •1.3. Subcutaneous panniculitis-like T-NHL
- •1.4. Angioimmunoblastic T-cell lymphoma
- •1.5. Peripheral T-cell lymphoma, unspecified (T-NHL NOS)
- •2. Aged 18 - 65 years inclusive, either sex
- •3. Stage II or more
- •4. WHO performance status 0, 1 or 2
- •5. Measurable disease
- •6. Written informed consent
排除标准
- •1. Patients with NK/T-NHL of the following type:
- •1.1. Precursor T cell lymphoblastic lymphoma/leukaemia
- •1.2. All mature T cell leukaemias (T-PLL, ATLL, NK cell leukaemia, T-LGL)
- •1.3. Anaplastic large cell lymphoma
- •1.4. Hepatosplenic T cell lymphoma
- •1.5. Enteropathy-type T cell lymphoma without measurable disease
- •1.6. Blastic NK cell lymphoma
- •2. Intolerance of exogenous protein administration
- •3. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II - IV, appendix F) or left ventricular ejection fraction (LVEF) less than 45%
- •4. Significant renal dysfunction (serum creatinine greater than or equal to 150 µmol/l), unless related to NHL
- •5. Significant hepatic dysfunction (total bilirubin greater than or equal to 30 µmol/l or transaminases greater than or equal to 2.5 times normal level), unless related to NHL
- •6. Suspected or documented central nervous system involvement by NHL
- •7. Patients known to be human immunodeficiency virus (HIV)-positive
- •8. Patients with active, uncontrolled infections
- •9. Patients with uncontrolled asthma or allergy, requiring steroid treatment
- •10. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localised lymphoma mass or infiltration
- •11. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
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