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) - Imatinib vs. nilotinib for treatment of newly diagnosed chronic phase CM

ovartis Pharma BV0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

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.

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 any of these drugs during study treatment.;* 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 cont

研究者

发起方

ovartis Pharma BV

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