ISRCTN03739647已完成3 期
Phase III, open-label, randomised, multicentre efficacy and safety study of bendamustine hydrochloride versus chlorambucil in treatment-naive patients with (Binet Stage B/C) chronic B-Cell Lymphocytic Leukaemia (B-CLL) requiring therapy
Mundipharma Research Ltd (UK)0 个研究点目标入组 319 人开始时间: 2005年11月23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
- 319
研究概览
简要总结
2009 results in https://pubmed.ncbi.nlm.nih.gov/19652068/ (added 10/06/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Treatment-naive
- •2. Confirmed chronic B-cell lymphocytic leukemia
- •3. Symptomatic Binet stage B or Binet stage C disease
- •4. Written informed consent
- •5. World Health Organization (WHO) performance status 0 - 2
- •6. Life expectancy greater than 3 months
排除标准
- •1. Previous treatment with other cytotoxic drugs
- •2. Participation in another clinical trial within 4 weeks prior to or during this study
- •3. Mental disorders
- •4. History of a second malignancy
- •5. Manifest immune hemolysis or immune thrombocytopenia that can be treated with glucocorticoids alone
- •6. Richter's syndrome or transformation to Prolymphocytic Leukemia (PLL)
- •7. Abnormal liver, renal and cardiac function
- •8. Known Human Immunodeficiency Virus (HIV) infection
- •9. Major surgery within 30 days before the start of the trial
- •10. Pregnancy
- •11. Lactation
研究者
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