EUCTR2005-001818-41-IT进行中（未招募）不适用
An open label multicenter expanded access study of oral AMN107 in adult patients with imatinib Glivec/Gleevec resistant or intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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
- •Patients under consideration for participation in this study must meet one of the following disease inclusion criteria as defined in 1, 2, or 3. Inclusion criteria number 4 applies to all three groups CML-BC, CML-AP, and CML- CP. 1. Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis defined as at least 30 blasts in peripheral blood and/or bone marrow or extramedullary disease excluding liver and spleen 2. Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML patients in accelerated phase defined with one or more of the following criteria present within 4 weeks prior to beginning treatment 8805; 15 but 30 blasts in blood or bone marrow 8805; 30 blasts plus promyelocytes in peripheral blood or bone marrow providing that 30 blasts present in bone marrow peripheral basophils 8805; 20 thrombocytopenia 100 X 109/L unrelated to therapy 3. Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in chronic phase defined with the following criteria 15 blasts in peripheral blood and bone marrow 30 blasts plus promyelocytes in peripheral blood and bone marrow 20 basophils in the peripheral blood 8805; 100 x 109/L 8805; 100,000/mm3 platelets No evidence of extramedullary leukemic involvement, with the exception of liver and spleen 4. CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib-resistance or intolerance are eligible 5. Males or females 8805;18 years of age
- •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
- •1. Cytopathologically confirmed CNS infiltration. in absence of suspicion of CNS involvement, lumbar puncture is not required 2. Impaired cardiac function, including any one of the following LVEF 45 as determined by MUGA scan or echocardiogram Complete left bundle branch block Use of a cardiac pacemaker ST depression of 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads Congenital long QT syndrome History of or presence of significant ventricular or atrial tachyarrhythmias Clinically significant resting bradycardia 50 beats per minute QTc 480 msec on screening ECG using the QTcF formula The ICH guideline criterion of 450 msec has been increased to 480 msec to allow patient with this life threatening disease where no medication is currently approved, providing an acceptable benefit-risk for the patient. Right bundle branch block plus left anterior hemiblock, bifascicular block Myocardial infarction within 3 months prior to starting AMN107 Uncontrolled angina pectoris Other clinically significant heart disease e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen 3. Use of therapeutic coumarin derivatives i.e., warfarin, acenocoumarol, phenprocoumon up to the day before study drug administration 4. Acute or chronic liver or renal disease considered unrelated to tumor
研究者
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