View Clinical Trial (Medical Research Study)

Extension Study to 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)

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Conditions:		Myelogenous Leukemia, Chronic
Purpose:		This study will evaluate the safety and tolerability of nilotinib after failure of imatinib therapy or imatinib therapy after nilotinib failure.
Study Summary:
Criteria:		Inclusion criteria: 1. Male or female patients ≥ 18 years of age. 2. ECOG 0, 1, or 2. 3. Patients with Ph+ CML who have failed treatment in the core protocol. 4. Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL a review of a minimum 20 metaphases is required). 5. 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. 6. 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. Exclusion criteria: 1. Previously documented T315I mutations. 2. 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.
NCT ID:		NCT00718263
Primary Contact:		Study Director Novartis Pharmaceuticals Novartis Pharmaceuticals Novartis Pharmaceuticals Phone: +1(800)340-6843
Backup Contact:		N/A
Location Contact:		Miami, Florida 33176 United States Maria Sangiovanni Phone: 305-854-3046 Email: marias@ams-ohrc.com Site Status: Not yet recruiting

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