EUCTR2012-002795-13-GB进行中（未招募）1 期
A phase II trial of Cyclosporin A in Early Adverse Risk CLL - CyCLLe
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
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
- •Stage A or B CLL (Binet system) not requiring therapy by conventional criteria
- •= 2 lines of previous therapy for CLL
- •ECOG performance status =2
- •Life expectancy >12 months
- •No therapy for CLL in previous 3 months (including glucocorticoids)
- •CD38+ve; = 7%
- •Normal renal function (eGFR >60mls/min)
- •Normal liver function (AST and / or ALT <1.5 ULN)
- •Negative serology for Hepatitis B, C and HIV
- •Valid informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Active infection
- •Active autoimmune disease (requiring therapy)
- •Diabetes Mellitus
- •Previous myocardial infarction or history of cardiac dysrhythmia.
- •Uncontrolled hypertension
- •Taking medication known to cause serious interaction with CsA where the interaction cannot be prevented by monitoring and adjusting CsA level
- •Fludarabine refractory disease (Non response to or relapse within 6 months of fludarabine containing regimen)
- •Previous bone marrow transplant
- •History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
- •Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
- •Patients and partners of childbearing potential not willing to use effective contraception during and for 3 months after therapy
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