EUCTR2005-005047-26-NL进行中（未招募）1 期
A phase III multi-center, open-label, randomized study of the efficacy of nilotinib versus imatinib in adult patients with Philadelphia chromosome positive (Ph+ ) chronic myelogenous leukemia in chronic phase (CML - CP) who have suboptimal cytogenetic response (CyR) on imatinib. - CAMN107A2302
ovartis Pharma Services0 个研究点目标入组 0 人开始时间: 2007年10月24日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
入选标准
- •Male and female patients = 18 years of age.
- •ECOG performance status of 0,1, or 2.
- •Diagnosis of Ph+ CML-CP defined as:
- •<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 hepatosplenomegaly
- •Patients with suboptimal cytogenetic response to a dose of at least 400 mg imatinib defined as = 6 to < 12 months of treatment and have 36 - 95% Ph+ metaphases, or = 12 to < 18 months of treatment and have 1 - 35% Ph+ metaphases.
- •Total bilirubin <1.5XULN; SGOT and SGPT <2.5XULN; creatinine < 1.5XULN, potassium and magnesium = LLN or correctable with supplements. Serum amylase and lipase = 1.5xULN, alkaline phosphatase = 2.5XULN unless considered tumor related.
- •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
- •Prior accelerated phase or blast phase CML.
- •Previously documented T315I mutation.
- •Achieved prior PCyR or CCyR and lost that response prior to entering the study.
- •Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
- •Patients who have received more than 18 months of imatinib therapy.
- •Intolerance to imatinib 400 mg/day defined as the inability to maintain dosing of at least 400 mg daily for the previous 3 months.
- •Previous treatment with any other tyrosine kinase inhibitor except imatinib.
- •Impaired cardiac function including any of the following: LVEF by echocardiography < 45% or below the institutional lower range (whichever is greater); complete left bundle branch block; ST depression > 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads; congenital long QT syndrome or family history of; history or presence of significant ventricular or atrial tachyarrhythmias; clinically significant resting brachycardia (< 50 bpm); QTcF > 450 msec at baseline; right bundle branch block plus left anterior hemiblock, bifascicular block; myocardial infarction = 3 months; uncontrolled angina; other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with antihypertensives).
- •Treatment with strong inhibitors of CYP3A4 or medications that have been well documented to prolong the QT interval is contraindicated (see Concomitant Therapy section in protocol).
研究者
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