EUCTR2011-004912-43-AT进行中（未招募）不适用
Fludarabine/Rituximab combined with escalating doses of Lenalidomide in untreated chronic lymphocytic leukemia (CLL) – a dose-finding study with escalating starting dose of Lenalidomide and concomitant evaluation of safety and efficacy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •Signed written informed consent
- •Male or female = 18 years of age
- •CLL (as determined by CD23+, CD5+, CD19+)
- •Treatment indication as defined by the NCI Workshop criteria (see appendix 5 and reference 10)
- •No previous treatment of the CLL by chemotherapy, radiotherapy (except localized radiotherapy of 1 lymphatic area) or immunotherapy
- •Life expectancy > 6 months (except prognosis due to high risk CLL)
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Active bacterial, viral or fungal infection
- •Positivity for HIV, Hepatitis B or C
- •Reduced organ functions and bone marrow dysfunction not due to CLL
- •Creatinine clearance of below 30 ml/min
- •Patients with a history of other malignancies within 2 years prior to study entry (except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent)
- •Patients with medical co-morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment
- •Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina
- •Other known co-morbidity with the potential to dominate survival
- •Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter'ssyndrome, or prolymphocytic leukemia (PLL))
- •Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the applied drugs
- •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapynot indicated in the study protocol
- •Administration of any investigational agent(s) within 4 weeks prior to entry
- •Pregnancy or lactation
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
研究者
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