EUCTR2008-004384-19-IT进行中（未招募）不适用
Front-line treatment of Philadelphia positive (Ph pos), BCR-ABL positive, chronic myeloid leukemia (CML) with two tyrosine kinase inhibitors (TKI) (Nilotinib and Imatinib). A phase II exploratory multicentric study. - GIMEMA CML0408
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO0 个研究点开始时间: 2008年7月28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
- •1.Patients with a cytologic and cytogenetic confirmed diagnosis of Ph pos CML.
- •2.Age ≥ 18 years old
- •3.Early chronic phase (ECP) (within 6 months from diagnosis)
- •4.No prior treatment with Imatinib for more than 30 days, with a washout period of at least 7 days
- •5.WHO performance status 0/1
- •6.Normal serum level of potassium, total calcium corrected for serum albumin, magnesium and phosporus, or correctable with supplements
- •7.ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia.
- •8.Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia.
- •9.Serum bilirubin ≤ 1.5 x ULN
- •10.Serum creatinine ≤ 1.5 x ULN
- •11.Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN.
- •12.Written 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.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 12 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.History of acute (within one year) or chronic pancreatitis.
- •5.Impairment of gastrointestinal (GI) function, or a GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- •6.Use of therapeutic coumarin derivates (i.e. warfarin, acenocoumarol, phenprocoumon).
- •7.Acute or chronic liver or renal disease considered unrelated to leukaemia
- •8.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
- •9.Patients who are currently receiving treatment with any of the medications listed in Appendix G and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix G have the potential to prolong QT.
- •10.Patients who have received Imatinib for more than 30 days, or have been submitted to HSCT.
- •11.Patients who have received any investigational drug ≤ 4 weeks.
- •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.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 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 dr
- •14.Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).
- •15.Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
- •16.Patients unwilling or unable to comply with the protocol.
研究者
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