EUCTR2013-004370-10-ES进行中（未招募）不适用
A phase II study of ruxolitinib (INCB018424) to evaluate efficacy and safety in Patients with Proliferative Chronic Myelomonocytic Leukemia (CMML) - RUXO_LMMC-PRO_1401
Grupo Español de Sindromes Mielodisplásicos (GESMD)0 个研究点开始时间: 2014年2月7日最近更新:
适应症
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
- •?Proliferative CMML according to French-American-British (FAB) diagnostic criteria.
- •?Proliferative CMML patients with CMML-specific prognostic scoring system (CPSS) low risk or intermediate 1; or intermediate-2 or high who are not transplant candidates.
- •?Patients must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic. If not, a 15 cm or greater measured by ultrasonography.
- •?To understand and voluntarily sign an informed consent form.
- •?Age ?18 years at the time of signing the informed consent form.
- •?Be able to adhere to the study visit schedule and other protocol requirements.
- •?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 beta (PDGF?) can be included if standard treatment with imatinib failed.
- •?ECOG performance status of ?2 at study entry
- •?Laboratory tests results within these ranges:
- •-Creatinine clearance >30 mL/min.
- •-AST (SGOT) and ALT (SGTP) ?2.5 x ULN
- •?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.
- •?Female subjects of childbearing potential must:
- •-Understand that study drug is expected to have a teratogenic risk
- •-Agree to use two effective contraception methods
- •?Male subjects must:
- •-Agree to use condoms
- •-Agree not to donate semen
- •?All subjects must:
- •-Agree to abstain from donating blood
- •-Agree not to share study drug with another person
- •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 5
排除标准
- •?Patients with inadequate bone marrow reserve as demonstrated by:
- •-Absolute neutrophil count (ANC) that is ? 1000/?L.
- •-Platelet count that is <50,000/?L without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
- •?Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
- •?Patient transplant candidates with CMML specific prognostic scoring system (CPSS) intermediate 2 or high risk.
- •?Pregnant or breast feeding females (lactating females must agree not to breast feed while taking INC424).
- •?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.
- •?To use any other experimental drug or therapy within 28 days of baseline.
- •?Any prior use of INC424
- •?Concurrent use of other anti-cancer agents or treatments.
- •?Known positive for HIV or infectious hepatitis, type A, B or C.
- •?Any of concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. For example:
- •-Uncontrolled diabetes
- •-Active or uncontrolled infection
- •-Uncontrolled hypothyroidism
- •-Acute or chronic liver or renal disease
- •?Platelet count less than 50 x109/L.
研究者
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