ISRCTN84606869已完成2 期
A single arm phase II study to investigate the use of Lenalidomide in the treatment of patients with early stage chronic lymphocytic leukaemia (CLL) associated with poor prognostic factors
Christie NHS Foundation Trust (UK)0 个研究点目标入组 40 人开始时间: 2010年3月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Binet stage A CLL
- •2. Two or more risk factors:
- •2.1. Unmutated IgVH locus (=98% homology to germline sequence)
- •2.2. CD38 expression (greater than 7%)
- •2.3. Deletion of chromosome 11q22 (greater than 20% by FISH)
- •2.4. Deletion of chromosome 17p13 (greater than 10% by FISH)
- •3. Over 18 years old, either sex
- •4. Capable to provide written informed consent
- •5. Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- •6. Life expectancy greater than 2 years
- •7. Must agree to not share study lenalidomide with someone else
- •8. Must agree not to donate blood whilst taking the study drug and for one week after discontinuation of treatment
- •9. Female subjects of child bearing potential and all male subjects must agree to comply with the stipulations of the pregnancy prevention plan
排除标准
- •1. Current or recent (within the last 1 month) participation in another clinical trial investigation the action of an investigational medicinal product for the treatment of CLL
- •2. Pregnant or lactating
- •3. Known positivity for human immunodeficiency virus (HIV) types 1 or 2
- •4. Prior history of malignancies, other than CLL, unless the subject was treated with curative intent and has been free of the disease for 3 years. Exceptions include the following:
- •4.1. Basal cell carcinoma of the skin
- •4.2. Squamous cell carcinoma of the skin
- •4.3. Carcinoma in situ of the cervix
- •4.4. Carcinoma in situ of the breast
- •5. Significantly abnormal renal or hepatic function:
- •5.1. Creatinine clearance less than 60 ml/min (measured or calculated)
- •5.2. Serum aspartate aminotransferase (AST) greater than 3 x upper limit of normal (ULN)
- •5.3. Serum bilirubin greater than 34 µmol/l
- •6. Laboratory tumour lysis syndrome according to the Cairo-Bishop classification. Subjects may be enrolled when these abnormalities have been corrected.
- •7. Peripheral neuropathy (grade = 2)
- •8. Previous treatment for CLL
- •9. Previous treatment with Thalidomide or immunomodulatory derivative drugs (including lenalidomide)
- •10. Treatment with corticosteroids (for CLL or other indications) less than 28 days from study entry
- •11. Evidence of Richter's transformation
- •12. Unsupported absolute neutrophil count less than 1 x 10^9/l or platelet count less than 50 x 10^9/l not due to CLL
- •13. Active autoimmune haemolytic anaemia or thrombocytopenia
- •14. Any other medical or psychological condition that in the view of the investigator would be likely to impact compliance with the protocol or interfere with trial treatment
研究者
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