A pilot study to establish the safety and efficacy of a combination of dexamethasone and lenalidomide in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) - LenD (Lenalidomide in CLL)

niversity College London0 个研究点目标入组 12 人开始时间: 2012年1月4日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 12

研究概览入排标准研究者记录与标识符相似试验

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

•1. Diagnosis of relapsed or refractory CLL as defined by the NCIWG criteria, requiring treatment
•2. 1-3 lines of prior therapy
•3. Fludarabine-based therapy inappropriate
•4. Alemtuzumab-based therapy inappropriate
•5. WHO Performance status =2
•6. Age = 18 years
•7. Life expectancy > 6 months
•8. Male and female subjects must meet the inclusion criteria for the Lenalidomide Pregnancy Risk Minimisation Plan (or must meet the criteria for women of non-child-bearing potential).
•9. Male and female subjects (except women meeting the criteria of non-child-bearing potential) must agree to follow the Lenalidomide Pregnancy Risk Minimisation Plan(including contraception 4 weeks before, during and 4 weeks after treatment for females of child-bearing potential).
•10. Signed written 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 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

排除标准

•1. Previously untreated CLL
•2. Fit patients for whom alemtuzumab or fludarabine-based therapy would be appropriate
•3. Creatinine clearance < 30ml/min calculated by Cockcroft-Gault
•4. Bilirubin > 1.5 x upper limit of normal
•5. Patients with marrow suppression resulting in significant cytopenia (Neutrophils <0.5 x 10^9/l, Platelets <30 x 10^9/l).
•6. Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy or other investigational therapy within 4 weeks prior to study Day 1.
•7. Known infection with HIV, hepatitis B or hepatitis C.
•8. Uncontrolled glaucoma, diabetes mellitus, hypertension or symptomatic peptic ulcer disease
•9. Peripheral neuropathy > grade 1
•10. Proven or suspected transformation to aggressive B-cell malignancy (e.g. large B-cell lymphoma, Richter’s syndrome, or PLL).
•11. Second malignancy requiring treatment other than non metastatic skin tumours
•12. Any medical condition that would require long-term use (>1 month) of systemic corticosteroids at a dose greater than 5mg/day of prednisolone during study treatment.
•13. Active uncontrolled bacterial, viral or fungal infections
•14. Patients with uncontrolled cardiac failure or unstable angina
•15. Epileptic disorders requiring anticonvulsant therapy
•16. Major surgery, other than diagnostic surgery within 4 weeks prior to Study Day 1.
•17. Pregnant or currently breastfeeding.
•18. Patients who for other reasons are not expected to complete the study
•19. Subjects with a known allergy to allopurinol will be excluded from the study.

研究者

发起方

niversity College London

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