EUCTR2007-000208-34-GB进行中（未招募）1 期
A phase III multi-center, open label, randomised study of optimised imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 771
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 or female patients 18 years of age
- •ECOG 0, 1, or 2.
- •Patients with CML-CP within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis). Standard conventional cytogenetic analysis must be done on bone marrow. FISH cannot be used)
- •Diagnosis of chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL a review of a minimum 20 metaphases is required)
- •Documented chronic phase CML will meet all the criteria defined by:
- •< 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
- •Adequate end organ function as defined by:
- •total bilirubin < 1.5 x ULN
- •SGOT and SGPT < 2.5 x ULN
- •creatinine < 1.5 x ULN
- •Serum amylase and lipase = 1.5 x ULN
- •Alkaline phosphatase = 2.5 x ULN unless considered tumor related.
- •Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug.
- •Patients must have the following laboratory values (= LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):
- •Potassium = LLN
- •Magnesium = LLN
- •Phosphorus = LLN
- •Total calcium (corrected for serum albumin) = LLN.
- •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 747
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 99
排除标准
- •Patients who are considered Ph negative because they do not have a confirmed cytogenetic diagnosis of Philadelphia chromosome of (9,22) translocation.
- •Previously documented T315I mutations.
- •Treatment with tyrosine kinase inhibitor(s) prior to study entry is not allowed, except in the following situation: in emergent cases where the patient requires disease management while awaiting study start, commercial supplies of Gleevec/Glivec at any dose may be prescribed to the patient but for no longer than 2 weeks in duration.
- •Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
- •Impaired cardiac function including any one of the following:
- •LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram
- •Inability to determine the QT interval on ECG
- •Complete left bundle branch block
- •Use of a ventricular-paced pacemaker
- •Congenital long QT syndrome or a known family history of long QT syndrome.
- •History of or presence of clinically significant ventricular or atrial tachyarrhythmias
- •Clinically significant resting brachycardia (<50 beats per minute)
- •QTc > 450 msec on the average of 3 serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc
- •History of clinically documented myocardial infarction
- •History of unstable angina (during the last 122 months)
- •Other clinically significant heart disease (e.g. congestive heart failure or uncontrolled hypertension).
- •Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
- •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.
- •Treatment with other investigational agents within 30 days of Day 1.
- •History of non-compliance to medical regimens or inability to grant consent.
- •Use of therapeutic coumarin derivatives (i.e., warfarin,
- •acenocoumarol, phenprocoumon)
- •Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
- •Patients actively receiving therapy with strong CYP3A4 inducers (e.g, dexamthasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbitol, St. John's Wort) and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. See link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.
- •Novartis must be contacted if a patient needs to be started on
研究者
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