EUCTR2012-005062-34-IT进行中（未招募）不适用
An open label, single arm, phase II study of nilotinib 300 mg BID in newly diagnosedCP-CML patients, in order to verify disappearance of CD34+/lin-Ph+ cells from bone marrowduring treatment. - PhilosoPhi34
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2012年12月21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
- •1. Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph chromosome [(9;22) translocation] within 3 months of diagnosis; 2. Patients Ph negative or with variant translocations by standard cytogenetic analysis but Ph positive by FISH, are eligible as well; 3. Age = 18 years old (no upper age limit given); 4. WHO performance status =2; 5. Normal serum levels = LLN (lower limit of normal) of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements, prior to the first dose of study medication; 6. AST and ALT = 2.5 x ULN or = 5.0 x ULN if considered due to leukaemia; 7. Alkaline phosphatase = 2.5 x ULN unless considered due to leukaemia; 8. Total bilirubin = 1.5 x ULN, except know Mb Gilbert; 9. Serum lipase and amylase = 1.5 x ULN; 10. Serum creatinine = 1.5 x ULN; 11.Written informed consent signed prior to any study procedures being performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 87
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 87
排除标准
- •1. Pre-treatment with hydroxyurea for > 3 months and with imatinib is not permitted; 2. Prior accelerated phase including clonal evolution or blast crisis; 3. Contraindication to excipients in study medication; 4. Known impaired cardiac function including any of the following: a. LVEF < 45% b. Complete left bundle branch block c. Right bundle branch block plus left anterior hemiblock, bifascicular block d. Use of a ventricular-paced pacemaker e. Congenital long QT syndrome f. History or presence of clinically significant ventricular or atrial tachyarrhythmias g. Clinically significant resting bradycardia (< 50 beats per minute) h. QTcF > 450 msec on screening ECG. If QTcF > 450 msec and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion i. Myocardial infarction within 12 months prior to starting nilotinib j. Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension); 5. History of acute (i.e. within 1 year of starting study medication) or chronic pancreatitis; 6. Other concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol; 7. Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery); 8. Concomitant medications with potential QT prolongation (see link for complete list: http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm); 9. Concomitant medications known to be strong inducers or inhibitors of the CYP450 Isoenzyme CYP3A4:see link for complete list (http://medicine.iupui.edu/flockhart/table.htm); 10. Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy; 11. Patients who are pregnant or breast feeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of nilotinib. Post menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug; 12. Treatment with any haematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF) = 1 week prior to starting study drug; 13. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory); 14. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention; 15. Patients unwilling or unable to comply with the protocol.
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