EUCTR2009-012476-28-AT进行中（未招募）1 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.
F.Hoffmann-La Roche0 个研究点目标入组 786 人开始时间: 2009年9月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 786
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult patients, aged 18 years or older
- •2. Have documented CD20+ B-CLL
- •3. Previously untreated CLL requiring treatment according to the NCI criteria (Hallek,M; Blood 2008)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 262
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 524
排除标准
- •1. Prior CLL therapy
- •2. Transformation of CLL to aggressive NHL (Richter’s transformation)
- •3. History of other malignancy unless the malignancy has been in remission without treatment for = 2 years prior to enrolment.
研究者
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