EUCTR2008-007125-39-AT进行中（未招募）1 期
A phase I-II trial of lenalidomide, bendamustin and dexamethasone in the treatment of patients with systemic AL-amyloidosis and ineligible for stem cell transplantation - LeBenD
Klinik f. Innere Med., Fachabteilung Hämatologie0 个研究点目标入组 12 人开始时间: 2009年3月30日最近更新:
适应症
相关药物
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
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
- •Symptomatic primary systemic amyloidosis based on both: a tissue diagnosis of amyloidosis based on polarizing microscopy of green birefringent material in Congo red–stained tissue specimens and immunohistochemical stains of that tissue demonstrating monoclonal light chain deposition
- •Patient is not eligible for autologous stem cell transplantation
- •Age >18 years
- •Blood haemoglobin > 8g/dl
- •Platelets >60 x 109/l
- •WBC > 2,0 x 109/l
- •ANC > 1 x 109/l
- •Glomerular Filtration Rate >30ml/min
- •ECOG Performance Status of 0, 1 or 2
- •Patient’s written informed consent
- •Patient is able to take aspirin (100 mg) daily as prophylactic anticoagulation
- •Women of child-bearing potential must have a negative pregnancy test
- •Effective contraception for both men and women of child bearing
- •potential for the entire treatment period
- •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
- •Patient is eligible for autologous stem cell transplantation
- •Patient with end-stage renal failure or on dialysis
- •Pregnant or breast feeding women
- •Men and women of childbearing potential who are unwilling to use an effective method of contraception for the entire treatment period
- •Deep-vein thrombosis or pulmonary embolism at entry of study
- •Previous treatment for AL-amyloidosis within 4 weeks of study entry with chemotherapy
- •Previous treatment with lenalidomide or bendamustine
- •Known intolerance to lenalidomide, bendamustine or dexamethasone
- •Use of any investigational agent within 28 days prior to screening
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years.
研究者
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