ISRCTN84611849已完成3 期
A randomised phase III study of chimeric anti-CD20 monoclonal antibody (rituximab) with two-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate or high-risk non-Hodgkin?s lymphoma
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 400 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
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
入选标准
- •1. Patients with a confirmed histologic diagnosis of Non-Hodgkins Lymphoma (NHL) according to the World Health Organisation (WHO) classification:
- •a. Mantle Cell Lymphoma (MCL)
- •b. Follicular Lymphoma (grade III) (FL III)
- •c. Diffuse Large B-Cell Lymphoma (DLBCL)
- •2. Low-intermediate, high-intermediate or high risk NHL according to age-adjusted International Prognostic Index (IPI) score
- •3. NHL must be CD20 positive
- •4. Age 65 years or more
- •5. WHO performance status zero to two
- •6. Written informed consent
排除标准
- •1. Intolerance of exogenous protein administration
- •2. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II to IV) or Left Ventricular Ejection Fraction (LVEF) less than 45%
- •3. Significant renal dysfunction (serum creatinine greater than or equal to 150 mmol/l), unless related to NHL
- •4. Significant hepatic dysfunction (total bilirubin greater than or equal to 30 mmol/l or transaminases greater than or equal to 25 times normal level), unless related to NHL
- •5. Suspected or documented Central Nervous System involvement by NHL
- •6. Patients known to be Human Immunodeficiency Virus (HIV)-positive
- •7. Patients with active, uncontrolled infections
- •8. Patients with uncontrolled asthma or allergy, requiring steroid treatment
- •or treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localised lymphoma mass or infiltration
- •9. Story of active cancer during the past five years, except basal carcinoma of the skin or stage zero cervical carcinoma
研究者
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