EUCTR2005-001818-41-AT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
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:
- •= 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
- •= 50 x 109/L (= 50,000/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.Patients who have received dasatinib provided that they have had one day (24 hours) washout from their last dose of medication and have recovered from side effects of such therapy prior to starting study drug.
- •6. Males or females =18 years of age
- •7.WHO Performance Status of = 2
- •8.Patients must have the following laboratory values:
- •Potassium within normal limits or corrected to within normal limits with supplements
- •Total calcium (corrected for serum albumin) within normal limits or correctable with supplements
- •Magnesium within normal limits or corrected to within normal limits 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
- •9.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% or below the institutional lower limit of the normal range as determined by MUGA scan or echocardiogram
- •Complete left bundle branch block
- •Use of a ventricular-paced pacemaker
- •Congenital long QT syndrome
- •History of or presence of clinically significant ventricular or atrial tachyarrhythmias
- •Clinically significant resting bradycardia (< 50 beats per minute)
- •QTc > 450 msec on screening and on day 1 (using the QTcF formula).If QTc > 450 msec and electrolytes are not within normal ranges before AMN107 dosing, electrolytes should be corrected and then the patient rescreened for QTc criterion
- •Right bundle branch block plus left anterior hemiblock, bifascicular block
- •Myocardial infarction within 12 months prior to starting AMN107
- •Other clinically significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension)
- •3.Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration
- •4.Other concurrent severe and/or uncontrolled medical conditions, (e.g., uncontrolled diabetes, active or uncontrolled infection, acute or chronic liver disease considered unrelated to tumor, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107) that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
- •5.Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval or are strong CYP3A4 inhibitors(Post-text supplement 2) or who are within 5 half-lives of the last dose of this medication prior to starting study drug.
- •6.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. Hydroxyurea is permitted as clinically indicated at the investigators discretion prior to enrollment. Patients who have received imatinib within 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy.
- •7.Patients who have received immunotherapy =1 week prior to starting study drug or who have not recovered from side effects of such therapy
- •8.Patients who have received any investigational drug = 4 weeks or investigational drug/ 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
- •9.Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- •10.Known diagnosis of human deficiency virus (HIV) infection (HIV testing is not mandatory)
- •11.Patient with a history of another malignancy that is currently clinically significant or currently requires active intervention.
- •12.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 negative serum pregnancy test within 48 hrs prior to administration of AMN107). Post menopausal wome
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