EUCTR2005-001818-41-HU进行中（未招募）不适用
An open-label, multicenter, expanded access study of oral AMN 107 in adult patients with Imatinib (Glivec®/Gleevec®) - resistant or - intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase - NA
ovartis Pharma Services0 个研究点目标入组 2,000 人开始时间: 2006年1月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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:
- •= 15% but < 30% blasts in blood or bone marrow
- •= 30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that < 30% blasts present in bone marrow)
- •peripheral basophils = 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
- •= 100 x 109/L (= 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
- •The following inclusion criteria are mandatory for all patients:
- •5.Males or females =18 years of age
- •6.WHO Performance Status of = 2
- •7.Patients must have the following laboratory values:
- •Potassium within normal limits or correctable with supplements
- •Total calcium (corrected for serum albumin) within normal limits or correctable with supplements
- •Magnesium = LLN or correctable with supplements
- •Phosphorus = LLN or correctable with supplements
- •ALT and AST = 2.5 x ULN or = 5.0 x ULN if considered due to tumor
- •Alkaline phosphatase = 2.5 x ULN unless considered due to tumor
- •Serum bilirubin = 1.5 x ULN
- •Serum creatinine = 1.5 x ULN or 24-hour creatinine clearance ? 50 ml/min
- •Serum amylase = 1.5 x ULN and serum lipase = 1.5 x ULN
- •8.Written signed and dated informed consent prior to any study procedures being performed
- •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
- •5.Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
- •6.Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) = 1 week prior to starting study drug.
- •7.Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval (Post-text supplement 2).
- •8.Patients who have received chemotherapy = 1 week or who are within 5 half-lives of their last dose of chemotherapy (6 weeks for nitrosurea or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy. Patients who have received imatinib = 1 week or who have not recovered from side effects of such therapy.
- •9.Patients who have received immunotherapy =1 week prior to starting study drug or who have not recovered from side effects of such therapy
- •10.Patients who have received any investigational drug = 4 weeks or investigational cytotoxic agent within 1 week (or who are within 5 half-lives of a previous investigational cytotoxic agent) prior to starting study drug or who have not recovered from side effects of such therapy
- •11.Patients who have received wide field radiotherapy = 4 weeks or limited field radiation for palliation < 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- •12.Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- •13.Known diagnosis of human deficiency virus (HIV) infection (HIV testing is not mandatory)
- •14.Patient with a history of another malignancy that is currently clinically significant or currently requires active intervention.
- •15.Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a
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