NL-OMON39141招募中3 期
An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil (RClb)or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities. - BO21004/CLL11
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 3
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Have documented previously untreated CD20+ B-CLL according to NCI criteria
- •Total CIRS score >6 or creatinine clearance <70 ml/min or both
- •no additional bone marrow dysfunction
- •Age 18 years or older
- •Life expectancy >6 months
排除标准
- •Patients who have received previous CLL therapy
- •Transformation of CLL to aggressive NHL (Richter*s transformation)
- •Inadequate renal function: Creatinine clearance < 30 ml/min
- •Inadequate liver function
- •Patients with manifest auto-immune haemolytic anemia (AIHA). However, Coombs positive with no clinical signs of AIHA are eligible.
- •Patients with active bacterial, viral, or fungal infection requiring systemic treatment.
研究者
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