EUCTR2009-011078-14-GB进行中（未招募）1 期
A single arm phase II study to investigate the use of Lenalidomide in the treatment of patients with early stage CLL associated with poor prognostic factors. - RESPeCT: Revlimid Early Stage Poor prognosis CLL Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
入选标准
- •Binet stage A CLL
- •2 or more risk factors:
- •- Unmutated IgVH locus (=98% homology to germline sequence)
- •- CD38 expression (>7%)
- •- Deletion of chromosome 11q22 (>20% by FISH)
- •- Deletion of chromosome 17p13 (>10% by FISH)
- •Over 18 years old
- •Capable to provide written informed consent
- •ECOG performance status < 2
- •Life expectancy > 2 years
- •Must agree to not share study lenalidomide with someone else
- •Must agree not to donate blood whilst taking the study drug and for one week after discontinuation of treatment
- •Female subjects of child bearing potential and all male subjects must agree to comply with the stipulations of the pregnancy prevention plan
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •Pregnant or lactating
- •Known positivity for human immunodeficiency virus (HIV) types 1 or 2
- •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:
- •- Basal cell carcinoma of the skin
- •- Squamous cell carcinoma of the skin
- •- Carcinoma in situ of the cervix
- •- Carcinoma in situ of the breast
- •Significantly abnormal renal or hepatic function
- •- Creatinine clearance < 60ml/min (measured or calculated)
- •- Serum aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN)
- •- Serum bilirubin > 34µmol/l)
- •Laboratory tumour lysis syndrome according to the Cairo-Bishop classification. Subjects may be enrolled when these abnormalities have been corrected.
- •Peripheral neuropathy (grade = 2)
- •Previous treatment for CLL
- •Previous treatment with Thalidomide or immunomodulatory derivative drugs (including lenalidomide)
- •Treatment with corticosteroids (for CLL or other indications) < 28 days from study entry
- •Evidence of Richter’s transformation
- •Unsupported absolute neutrophil count < 1x109/l or platelet count < 50x109/l not due to CLL
- •Active autoimmune haemolytic anaemia or thrombocytopenia
- •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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