ISRCTN02757147已完成3 期
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia
German CLL Study Group - GCLLSG (Germany)0 个研究点目标入组 552 人开始时间: 2003年12月12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
- 552
研究概览
简要总结
2010 Results article in https://pubmed.ncbi.nlm.nih.gov/20194844/ (added 23/09/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Confirmed diagnosis of B-CLL according to National Cancer Institute (NCI)/German CLL Study Group (GCLLSG) criteria
- •2. Need for treatment
- •3. Age =18 years
- •4. Life expectancy >6 months
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •6. Patient's written informed consent
- •7. Willingness to contraception for the entire duration of the treatment and 2 months thereafter
排除标准
- •1. Manifest autoimmune cytopaenias including Coombs-positive autoimmune haemolytic anaemia
- •2. Active second malignancy requiring treatment (except basal cell carcinoma or malignant tumour treated curatively by surgery)
- •3. Prior chemotherapy and/or radiotherapy
- •4. Pregnancy, nursing
- •5. Concomitant disease requiring prolonged use of glucocorticoids (>1 month)
- •6. Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the study drugs
- •7. Active bacterial, viral or fungal infection
- •8. Creatinine clearance <70 ml/min
- •9. Total bilirubin >2 fold of upper normal limit
- •10. Total cumulative illness rating scale (CIRS) score >6
- •11. Cerebral dysfunction, legal incapacity
- •12. Richter's syndrome
研究者
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