EUCTR2009-013271-22-IT进行中（未招募）不适用
Front-line treatment of Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) with two tyrosine kinase inhibitors (TKI) (Imatinib and Nilotinib). A phase II exploratory multicentric study in elderly patients and in patients unfit for program of intensive therapy and allogeneic stem cell transplantation - GIMEMA LAL1408
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO0 个研究点开始时间: 2009年11月4日最近更新:
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
- •Patients with previously untreated Ph+ and/or BCR/ABL + ALL: o age 60 years old or o age > 18 years old, but unfit for program of intensive therapy and allogeneic SCT 2. Written informed consent prior to any study procedures being performed 3. Effective contraception
- •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. Impaired cardiac function, including LVEF < 45% as determined by MUGA scan or echocardiogram, uncontrolled congestive heart failure, uncontrolled hypertension 2. History of myocardial infarction within 3 months, or uncontrolled angina pectoris. 3. Significant electric heart abnormalities, including history or presence of significant ventricular or atrial tachyarrhythmias, congenital long QT syndrome and/or QTc > 450 msec on screening ECG (using the QTcF formula) 4. WHO performance status _ 50% (Karnofsky) or _ 3 (ECOG) 5. History of acute (within one year) or chronic pancreatitis. 6. Active HBV or HCV hepatitis, or AST/ALT more than 5 times ULN or bilirubine more than 5 time ULN or INR>1.5 7. Creatinine level >2.5mg/dl or VFG< 2ml/min or proteinuria >5g/day 8. Impairment of gastrointestinal (GI) function, or a GI disease that may significantly alter the absorption of study drugs (e.g., severe malabsorption syndrome, or extended small bowel resection) 9. Patients who are currently receiving treatment with any of the medications listed in Appendix D if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix D have the potential to prolong QT. 10. Patients who have received any investigational drug _ 4 weeks. 11. Patients who have undergone major surgery _ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy. 12. Patients who are pregnant 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 imatinib and nilotinib). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and 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 drugs. 13. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. 14. Patients unwilling or unable to comply with the protocol.
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