EUCTR2009-017147-33-AT进行中（未招募）不适用
A Phase I/II Study of Lenalidomide in Patients with Chronic Myelomonocytic Leukemia
AGMT gemeinnützige GmbH0 个研究点开始时间: 2010年1月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •selected inclusion criteria:
- •1.CMML according to the WHO diagnostic criteria
- •2.Understand and voluntarily sign an informed consent form.
- •3.Age >= 18 years at the time of signing the informed consent form.
- •4.Able to adhere to the study visit schedule and other protocol requirements.
- •5.All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (PDGFRB) can be included if standard treatment with imatinib failed.
- •6.ECOG performance status of >= 2 at study entry
- •7.Laboratory test results within these ranges:
- •Creatinine clearance > 30ml/min
- •AST (SGOT) and ALT (SGPT) >= 2.5 x ULN
- •8.Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •2.Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- •3.Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •4.Use of any other experimental drug or therapy within 28 days of baseline.
- •5.Known hypersensitivity to thalidomide.
- •6.The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •7.Any prior use of lenalidomide.
- •8.Concurrent use of other anti-cancer agents or treatments.
- •9.Known positive for HIV or infectious hepatitis, type A, B or C.
研究者
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