EUCTR2005-005047-26-IT进行中（未招募）不适用
A phase III randomized, open-label, multi-center study 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 - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 608
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
- •Male or female patients >= 18 years of age. ECOG performance status of 0, 1, or 2. Diagnosis of Ph+ CML in 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 >=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. Bone marrow karyotyping is required. FISH analysis is not allowed. 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. Ability to provide written informed consent prior to any study related screening 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
- •Prior accelerated phase or blast phase CML. Previously documented T315I mutations. 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 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 one of the following: LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) by echocardiography Complete left bundle branch block ST depression of >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 long QT syndrome History of or presence of significant ventricular or atrial tachyarrhythmias Clinically significant resting brachycardia (<50 bpm) QTcF > 450 msec on baseline ECG Right bundle branch block plus left anterior hemiblock, bifascicular block Myocardial infarction within one year of baseline visit Unstable angina diagnosed or treated within the past 12 months 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 (please see Section 6.6.4 for further guidance). Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection or gastric bypass surgery). History of acute pancreatitis within one year of study entry or medical history of chronic pancreaitis. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required). Any other malignancy that is clinically significant or requires active intervention. Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection). History of significant congenital or acquired bleeding disorder unrelated to cancer. Previous radiotherapy to >= 25% of the bone marrow. Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery. Use of therapeutic coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon). Treatment with other investigational agents within 30 days of Day 1 (first dose of study drug). History of non-compliance to medical regimens or inability to grant consent. Women who are pregnant, breast feeding, or of childbearing potential without a negative serum pregnancy test at baseline. Male or female patients of childbearing potential unwilling to use effective barrier contraceptives throughout the trial and for 3 months following discontinuation of study drug. Post-menopausal women must be ammenorrheic for at least 12 months to be considered of non-childbearing potential.
研究者
相似试验
进行中（未招募）
不适用
A phase III randomized, open-label, multi-center study 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.EUCTR2005-005047-26-DEovartis Pharma Services AG608
已完成
3 期
A phase III randomized, open-label, multi-center study 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) ib unatububChronic myeloid leukemia (CML)10024324NL-OMON31183Medisch Spectrum Twente5
进行中（未招募）
不适用
A phase III multi-center, open-label, randomized study 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. - CAMN107A2302ilotinib will be evaluated in patients having showed a suboptimal cytogenetic response to imatinibEUCTR2005-005047-26-HUovartis Pharma Services608
进行中（未招募）
1 期
A phase III multi-center, open-label, randomized study 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. - CAMN107A2302ilotinib will be evaluated in patients having showed a suboptimal cytogenetic response to imatinibMedDRA version: 9.1Level: LLTClassification code 10009700Term: CMEUCTR2005-005047-26-FRovartis Pharma Services
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. - CAMN107A2302EUCTR2005-005047-26-NLovartis Pharma Services