A phase II trial of Cyclosporin A in early adverse risk Chronic Lymphocytic Leukaemia (CLL)

niversity of Birmingham (UK)0 个研究点目标入组 5 人开始时间: 2014年3月5日最近更新: 2019年7月15日

适应症

试验速览

暂无简介。

•1. Stage A or B CLL (Binet system) not requiring therapy by conventional criteria
•2. = 2 lines of previous therapy for CLL
•3. Male and female, age =18
•4. ECOG performance status =2
•5. Life expectancy >12 months
•6. No therapy for CLL in previous 3 months (including glucocorticoids)
•7. CD38+ve = 7%
•8. Normal renal function (eGFR >60mls/min)
•9. Normal liver function (AST and / or ALT <1.5 ULN)
•10. Negative serology for Hepatitis B, C and HIV
•11. Valid informed consent

•1. Active infection
•2. Active autoimmune disease (requiring therapy)
•3. Diabetes Mellitus
•4. Previous myocardial infarction or clinically significant cardiac dysrhythmia.
•5. Uncontrolled hypertension
•6. Taking medication known to cause serious interaction with CsA where the interaction cannot be prevented by monitoring and adjusting CsA level
•7. Fludarabine refractory disease (Non response to or relapse within 6 months of fludarabine containing regimen)
•8. Previous bone marrow transplant
•9. 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.
•10. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
•11. Patients and partners of childbearing potential not willing to use effective contraception during and for 3 months after therapy

发起方

niversity of Birmingham (UK)