EUCTR2005-005047-26-DE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.
相关药物
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 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 400 mg imatinib (1st line therapy) 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 rquired on a min. of 20 metaphases. FISh analysis is not allowed.
- •The following laboratory results must be present:
- •Total bilirubin <1.5XULN; SGOT and SGPT <2.5XULN; Creatinine < 1.5XULN, Serum potassium, phosphorus, magnesium and calcium = LLN or correctable with supplements prior to the first doese of study drug. 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 on imatinib and lost that response prior to entering the study.
- •Prior treatment with > 400 mg/day of imatinib.
- •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 400 mg daily for the previous 3 months.
- •Previous treatment with any other tyrosine kinase inhibitor except imatinib.
- •Patients who had any other treatment for CML (e.g. interferon, transplant) except
- •hydroxyurea and/or anagrelide.
- •Impaired cardiac function including any one of the following:
- •LVEF < 45% by echocardiography
- •Complete left bundle branch block
- •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 screening ECG (using the QTcF formula). If QTc > 450 and
- •electrolytes are not with normal ranges, electrolytes should be corrected and then the patient rescreened for QTc
- •Use of a ventricular-paced pacemaker
- •Myocardial infarction within one year of the first dose of study drug
- •Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled
- •hypertension, unstable angina).
- •Treatment with strong inducers (e.g., dexamethasone, phenytoin, carbamazepine,
- •rifampin, rifabutin, rifapentin, phenobarbitol, St John’s Wort), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. See link in Section 6.6.4 for complete list of these medications.
- •Treatment with strong CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. See link in Section 6.6.4 for complete list of these medications.
- •Treatment with medications that have been well documented to prolong the QT interval is contraindicated. 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 pancreatitis.
- •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 chronic liver disease, pancreatic, or severe renal disease unrelated to tumor, active or uncontrolled infection).
- •History of significant congenital or acquired bleeding disorder unrelated to cancer.
- •Previous radiotherapy to = 25% of the bone marrow.
- •Patients who have had major surgery within 4 weeks prior to the first dose of study drug or who have not recovered from prior surgery.
- •Use of therapeutic coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon).
- •Treatment with other investigational agents within 28 days of Day 0 (first dose of
- •study drug).
- •History of non-compliance to medical regimens or inability to grant consent.
研究者
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