EUCTR2007-000208-34-IT进行中（未招募）1 期
A phase III multi-center, open-label, randomized study of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive Ph chronic myelogenous leukemia in chronic phase CML-CP - ND
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
- 846
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
- •Inclusion criteria Male or female patients 8805; 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 8805; 100 x 109/L 8805; 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 8804; 1.5 x ULN Alkaline phosphatase 8804; 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 8805; LLN lower limit of normal or corrected to within normal limits with supplements prior to the first dose of study medication. Potassium 8805; LLN Magnesium 8805; LLN Phosphorus 8805; 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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria 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 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 baseline ECG using the QTcF formula . If QTcF 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant heart disease e.g. unstable angina, 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 8805; 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 inhibitors e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil 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 any of these drugs during study treatment. Impairment of gastrointestinal GI function or GI disease that may significantly alter the absorption of study drug e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis. Acute or chronic liver, pancreatic or severe renal disease considered unrelated to disease. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval an
研究者
相似试验
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
进行中（未招募）
不适用
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. - CAMN107A2302ilotinib will be evaluated in patients having showed a suboptimal cytogenetic response to imatinibEUCTR2005-005047-26-BEovartis Pharma Services586
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. - CAMN107A2302EUCTR2005-005047-26-CZovartis Pharma Services608